25(OH)-vitamin D and Its Association with Bone Density, Body Composition, Strength, Walking Speed, Physical Performance and Pain in Hospitalized Individuals with Neurological Disorders

The NeuroVitD study aims to assess vitamin D levels in hospitalized cohorts with neurological disorders resulting in motor disabilities, providing epidemiological data necessary for guidelines. The primary objective is to assess vitamin D insufficiency in the neurological populations under investigation and secondary to evaluate the impact of vitamin D supplementation on problems associated with structural and functional parameters.
The NeuroVitD study will be a randomized, cluster, controlled intervention trial lasting 2 years, enrolling 120 individulas, (30 controls), including those with stroke, spinal cord injury, and traumatic brain injury. Comprehensive epidemiological data, including demographic and anthropometric information, will be documented alongside social behaviors such as exercise and smoking. Serum vitamin D levels, bone density, body composition, strength, speed, physical performance and pain will be assessed.
The study will also evaluate the effects of vitamin D supplementation at two distinct dosages: 50,000 I.U of vitamin D weekly for 8 weeks or 25,000 I.U of vitamin D for 4 weeks followed by 10,000 I.U of vitamin D drops weekly for an additional 4 weeks. Calcium, parathyroid hormone, and phosphorus levels will be assessed to examine the impact of vitamin D administration on additional biochemical markers.
The findings will encompass vitamin D levels, bone density, body composition, strength, walking speed, physical performance and pain. The impact of vitamin D supplementation on various biochemical parameters will be analyzed, along with gender and group comparisons. Correlations will be established based on participants' residential locations, the administration of vitamin D supplementation, seasonal variations, and associations with specific medications for neurological conditions.

Start Date01 Jun 2025

Sponsor / Collaborator-

NCT06861062

/ Not yet recruitingNot ApplicableIIT

Effects of Vitamin D3 and Yeast Beta-Glucan Supplementation on Cardiovascular Disease in Patients with Type 2 Diabetes: a Randomized Double-Blind Controlled Trial

This study is a randomized, double-blind, placebo-controlled trial involving 8,000 individuals aged 40-79 with type 2 diabetes. The trial includes a 2-year intervention period followed by 3 years of follow-up. The primary objective is to investigate whether daily dietary supplementation with vitamin D3 (1600 IU) or yeast β-glucan (600 mg) reduces the risk of major cardiovascular diseases, including myocardial infarction, stroke, treated or hospitalized heart failure, and cardiovascular deaths. The secondary objectives include evaluating the effects of vitamin D3 or yeast β-glucan supplementation on all-cause mortality, microvascular disease, cognitive function, and other outcomes.

Start Date20 Mar 2025

Sponsor / Collaborator

Huazhong University of Science & Technology

NCT05174611

/ RecruitingPhase 2IIT

Vitamin D as an Intervention for Improving Quadricep Muscle Strength in Patients After Anterior Cruciate Ligament Reconstruction: A Randomized Double-Blinded, Placebo-Controlled Clinical Trial

Quadriceps muscle strength is one of the key determinants for patients to fulfill the Return-to-Play (RTP) criteria after an anterior cruciate ligament reconstruction (ACLR), in which the muscle size is directly linked to muscle strength. Quadriceps muscle atrophy is unavoidable after ACLR, but the rehabilitation program should increase quadriceps muscle mass. However, despite good rehabilitation compliance, some patient's progress is sub-par and fail to regain muscle mass. Quadriceps muscle atrophy can persist beyond the completion of the rehabilitation program in almost half the patients and the reason behind this is still unknown. This represents an area that requires significant investigation, as quadriceps muscle atrophy and weakness have been shown to be determinants of poor knee function, decreased performance in sports and increased risk of reinjury.
Quadriceps muscle atrophy after ACLR is well documented. This can be due to a decreased ability to regain muscle mass with rehabilitation. Athletes are one of the high-risk groups for vitamin D insufficiencies. Vitamin D deficiency can potentially result in decreased hypertrophy when exercising the muscle, leading to a poorer outcome in rehabilitation. Vitamin D has long been recognized for its effect on musculoskeletal health. It can have a direct effect on muscle hypertrophy by acting on specific vitamin D receptors (VDRs) on myocytes, and sufficient or increased levels of vitamin D in patients have been found to correlate with an increase in the size, number, and strength of muscle fibres. Quadriceps muscle hypertrophy after ACLR is triggered by exercise training, facilitated by diet and a number of intrinsic factors. As the rehabilitation programs and diets are similar in patients with varying extents of quadriceps muscle atrophy, individual responses (intrinsic factors) to exercise training may account for the resulting persistent quadriceps muscle atrophy. In this study, the investigators hypothesize that the deficiency of vitamin D may contribute to persistent quadriceps atrophy and weakness.
With a stringent double-blinded randomized-controlled-trial (RCT) research design, our proposal will then address the research questions: 'Does vitamin D supplements improve the vitamin D deficiency status in patients after ACL reconstruction?', and 'Does vitamin D supplements improve quadriceps muscle strength for patients after ACLR?'

Start Date17 Mar 2025

Sponsor / Collaborator

The Chinese University of Hong Kong

100 Clinical Results associated with Colecalciferol

100 Translational Medicine associated with Colecalciferol

100 Patents (Medical) associated with Colecalciferol

45,278

Literatures (Medical) associated with Colecalciferol

31 Dec 2025·Environmental Pollutants and Bioavailability

Evaluating the influence of aquatic environmental hazard, polylactic acid microplastics, on Labeo rohita

Author: Al-Ghanim, Khalid A. ; Ali, Shafaqat ; Naeem, Adan ; Hussain, Syed Makhdoom ; Rashid, Eram ; Sarker, Pallab K.

This research sought to evaluate toxicity after intake of polylactic acid microplastics (PLA-MPs) on multiple parameters of Labeo rohita fingerlings, focusing on their growth, nutrient consumption, body composition, histopathol., hematol. and minerals status.Six test diets were formulated using sunflower meal (SFM) serving as the reference diet, incorporating different MPs concentrations: control (0%), 0.5%, 1%, 1.5%, 2% and 2.5% MPs.The formulated diets were administered to triplicate groups of 15 fish, with each fed at 5% weight (live wet) for 90 days duration.The outcomes revealed that the growth had significantly decreased in L. rohita fingerlings when exposed to PLA-MPs.Furthermore, the apparent nutrients digestibility reduced with the escalation in PLA-MPs levels.PLA-MP exposure led to substantial alterations in body composition, including enhanced body fat and reduced protein content.Furthermore, blood profile was also altered after the PLA-MPs exposure.Addnl., examination of gut histopathol. indicated an intensification in abnormalities in intestine at the 2.5% PLA-MPs concentrationThe diet having 2.5% MPs exhibited the min. body mineral compositionThis study suggests that exposure of PLA-MPs influenced the L. rohita health performance.

01 Dec 2025·IMMUNOLOGIC RESEARCH

Arginine vasopressin (AVP) treatment increases the expression of inhibitory immune checkpoint molecules in monocyte-derived dendritic cells

Article

Author: Naseri, Bahar ; Baradaran, Behzad ; Ghahramanipour, Zahra ; Sohrabi, Sepideh ; Karimzadeh, Hadi ; Mardi, Amirhossein ; Baghbani, Elham ; Masoumi, Javad

Arginine vasopressin (AVP) has disparate impacts on immune responses by divergent receptors on cells including DCs. This study was conducted with the aim of investigating the impact of AVP on the maturation and expression of the inhibitory immune checkpoint molecules in tolerogenic monocyte-derived DCs. CD14 marker was used to separate monocytes from peripheral blood mononuclear cells (PBMCs) by MACS method. To differentiate monocytes from DCs, we utilized GM-CSF and IL-4 cytokines. Tolerogenic DCs were generated using vitamin D3 and dexamethasone. We added LPS and AVP to the culture medium on day 6 after incubation of DCs at 37 °C. Finally, we assessed the surface molecules by flow cytometry and used real-time PCR to evaluate the expression of genes related to the inhibitory immune checkpoints. Based on the obtained data, AVP increased the expression of CD11c (P ≤ 0.0001), HLA-DR (P ≤ 0.01), and CD86 (P ≤ 0.01) in AVP-mDCs. Also, the expression of all the immune checkpoint genes including CTLA-4 (P ≤ 0.001), BTLA (P ≤ 0.001), PDL-1 (P ≤ 0.05), B7H7 (P ≤ 0.001), LAG3 (P ≤ 0.01), and VISTA (P ≤ 0.001) in AVP-mDCs was increased in comparison to the control group. Vasopressin caused the generation of mature and tolerogenic DCs. Our data may help to consider AVP-mDCs to take part in autoimmune disease therapy, transplanted tissue rejection impedance, and allergies.

01 Dec 2025·INFLAMMATION RESEARCH

Vitamin D3 suppresses NLRP3 inflammasome pathway and enhances steroid sensitivity in a neutrophilic steroid hyporesponsive asthma mouse model

Article

Author: Hundt, Jennifer ; Mdkhana, Bushra ; Hamid, Qutayba ; Khalil, Bariaa ; Selvakumar, Balachandar ; Hachim, Ibrahim ; Halwani, Rabih ; Sharif-Askari, Narjes Saheb ; Zakri, Adel

OBJECTIVE:

Severe steroid hyporesponsive asthma is a heterogeneous group of chronic inflammatory diseases characterized by irreversible airflow limitation, hyperresponsiveness, inflammation, and remodelling of the airways. Severe asthmatics account for more than 60% of asthma-related healthcare cost worldwide given they are hyporesponsive to corticosteroids and due to the absence of targeted treatment specifically for the T helper-17 (Th-17) high endotype. Hence, there is a clear unmet need to investigate other treatment options to control patients' symptoms. The role of the NLRP3 inflammasome pathway has been highlighted in the literature to contribute to disease pathogenesis and severity. Interestingly, vitamin D3 is an important regulator of the NLRP3 inflammasome pathway.

METHODS:

Using house dust mite (HDM) and lipopolysaccharide (LPS), we induced a neutrophilic steroid hyporesponsive asthma mouse model to investigate the effect of vitamin D3 on downregulating the NLRP3 inflammasome pathway and enhancing steroid sensitivity.

RESULTS:

We showed that calcitriol, the active form of vitamin D3, could downregulate the NLRP3 inflammasome pathway. This was associated with a significant reduction in airway hyperresponsiveness, IL-17 release, neutrophil infiltration, and mucus secretion. Further, calcitriol enhanced steroid sensitivity by inhibiting the expression of GR-β. Mechanistically, calcitriol targeted the NLRP3 inflammasome to ubiquitination.

CONCLUSIONS:

Our research highlights the potential use of calcitriol as a low cost and accessible supplement to ameliorate airway inflammation during severe steroid hyporesponsive asthma.

145

News (Medical) associated with Colecalciferol

04 Mar 2025

·www.prnewswire.com

Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®

STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1], [2] The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences from the reference products With the FDA approval of STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) Celltrion's biosimilar portfolio continues to grow, expanding treatment options to reach more patients JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively for all indications of reference products.[1], [2] "The approval of STOBOCLO and OSENVELT is another step forward in our efforts to deliver cost-effective and high-quality treatments that address critical unmet needs in osteoporosis-related fracture as well as cancer-related skeletal events," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "Patients deserve therapeutic options that have the potential to make real impacts on their care and their lives. We are committed to continuous innovation to meet these goals leveraging our experience and successful track record with biosimilar and novel biologics." The FDA approval is based on robust clinical evidence, including results from Phase III clinical trials in postmenopausal women with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of CT-P41 to reference denosumab. Study results demonstrated that CT-P41 had equivalent efficacy and PD to reference denosumab with similar PK and comparable safety and immunogenicity profiles. "Denosumab is used to improve or protect bone health in patients with osteoporosis or those undergoing various cancer treatments and as a therapy for a lifetime for postmenopausal osteoporosis (PMO) patients," said Prof. Jean-Yves Reginster, Professor of Medicine, Protein Research Chair, Biochemistry Dept, College of Science, King Saud University, Riyadh, Kingdom of Saudi Arabia and Director WHO Collaborating Centre for Epidemiology of Musculoskeletal Health and Aging, Liège, Belgium. "Biosimilars have expanded into new therapeutic areas such as immunology, oncology and ophthalmology as they continue to offer significant cost-saving potential while expanding patient access. Having a denosumab product with a clinically proven track record in quality and safety is a valuable addition for my patients." In accordance with a settlement agreement with Amgen Inc., STOBOCLO and OSENVELT are expected to be available in the U.S. in June 2025. About STOBOCLO® (denosumab-bmwo) STOBOCLO® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing PROLIA ® (denosumab). STOBOCLO 60 mg/mL injection is approved by the FDA based on comprehensive data and clinical evidence confirming the therapeutic equivalence to PROLIA. In the U.S., STOBOCLO is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. STOBOCLO was also approved by the European Medicines Agency (EMA) in February 2025. INDICATIONS STOBOCLO® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in women at high risk for fracture receiving a adjuvant aromatase inhibitor therapy for breast cancer IMPORTANT SAFETY INFORMATION WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease, including those on dialysis, face a higher risk of severe hypocalcemia after denosumab administration, with reported cases leading to hospitalization, life-threatening events, and fatalities. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients Before starting STOBOCLO® (denosumab-bmwo) in advanced chronic kidney disease patients, assess for CKD-MBD. Treatment should be supervised by a healthcare provider experienced in diagnosing and managing CKD-MBD. STOBOCLO is contraindicated in hypocalcemia, pregnant women, and in patients with known hypersensitivity to denosumab. Severe Hypocalcemia: Ensure adequate calcium and vitamin D; monitor for severe hypocalcemia. Drug Products with Same Active Ingredient: Do not use with other denosumab products. Hypersensitivity : If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of STOBOCLO. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on STOBOCLO. Conduct oral exams before treatment; maintain oral hygiene; consider discontinuation of STOBOCLO if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of STOBOCLO therapy should be considered, pending a benefit-risk assessment, on an individual basis. Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment: Increased risk post-discontinuation of denosumab; transition to alternative therapy if discontinuing STOBOCLO. Serious Infections: Higher risk in denosumab users; assess benefit-risk profile, especially in immunocompromised patients. Assess the benefit-risk profile before starting STOBOCLO and reconsider its use if serious infections develop. Dermatologic Adverse Reactions: Consider discontinuing STOBOCLO if severe dermatitis, eczema, or rashes occur. Musculoskeletal Pain: Consider discontinuation of STOBOCLO if severe pain develops. Bone Turnover Suppression: In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodelling; patients should be monitored for these outcomes. Hypercalcemia in Pediatrics Patients with Osteogenesis Imperfecta: Not for pediatric use; hypercalcemia reported in patients osteogenesis imperfecta treated with denosumab products. Most common Adverse Reactions: In (>5%) of patients with: Postmenopausal osteoporosis were back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis were back pain, arthralgia, and nasopharyngitis. Glucocorticoid-induced osteoporosis (> 3%) were back pain, hypertension, bronchitis, and headache. Bone loss due to hormone ablation for cancer (≥ 10%) were arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. For more information, see Full Prescribing Information. About OSENVELT® (denosumab-bmwo) OSENVELT® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing XGEVA ® (denosumab). OSENVELT 120 mg/1.7 mL (70 mg/mL) injection is approved by the FDA based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to XGEVA. In the U.S., OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. OSENVELT was also approved by the European Medicines Agency (EMA) in February 2025. INDICATION OSENVELT® (denosumab-bmwo) is indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. IMPORTANT SAFETY INFORMATION Contraindications: Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products. Drug Products with Same Active Ingredient. Patients receiving OSENVELT should not receive other denosumab products concomitantly. Hypersensitivity. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT. Hypocalcemia. Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on OSENVELT. Conduct oral exams and appropriate preventive dentistry before and during treatment; maintain oral hygiene and avoid invasive dental procedures; consider discontinuation of OSENVELT if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of OSENVELT therapy should be considered, pending a benefit-risk assessment, on an individual basis. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons. Clinically significant hypercalcemia, potentially requiring hospitalization, can occur within a year after stopping denosumab in patients with giant cell tumor of bone or growing skeletons; monitor serum calcium and manage calcium and vitamin D needs post-discontinuation. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation. Increased risk post-discontinuation of denosumab; evaluate for risk for vertebral fractures after discontinuing OSENVELT. Embryo-Fetal Toxicity. Denosumab may cause fetal harm; verify pregnancy status before starting OSENVELT and advise effective contraception during treatment and for 5 months after the last dose. Most common Adverse Reactions: Bone Metastasis from Solid Tumors (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. In patients (≥ 10%) with: Multiple Myeloma were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache; Giant Cell Tumor of Bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Hypercalcemia of Malignancy (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. For more information, see Full Prescribing Information . About Celltrion Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website . and stay updated with our latest news and events on our social media - LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has seven biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), STEQEYMA® (Ustekinumab-stba), and AVTOZMA® (tocilizumab-anoh) as well as a novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit , and stay updated with our latest news and events on our social media - LinkedIn FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc. and its subsidiaries that may constitute forward-looking statements, under pertinent securities laws. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect to the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks STOBOCLO® and OSENVELT® are registered trademarks of Celltrion Inc. PROLIA® and XGEVA® are registered trademarks of Amgen Inc. References US-CT-P41-24-00010 For further information please contact:  Andria Arena [email protected] +1 516-578-0057 SOURCE Celltrion WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3Clinical Result

06 Feb 2025

·www.drugs.com

Vitamin D in Early Pregnancy Could Boost Baby's Health

THURSDAY, Feb 6, 2024 -- Getting enough vitamin D, the "sunshine vitamin," during early pregnancy could be important for infant health, new research suggests. Researchers at Penn State found that infants born to women deficient in the nutrient were more likely to be delivered prematurely. Those newborns were also more likely to be smaller compared to babies delivered by women who'd gotten enough of the vitamin in their first trimester. “This study provides evidence that early pregnancy -- and even pre-conception -- nutrition is vitally important,” lead study author Celeste Beck said. She was a doctoral student at Penn State's University Park campus when the study was conducted, and is now an associate research scientist at Heluna Health. “We can't just assume that everybody is deficient, but proper nutrition is something that needs to be on your radar if you may become pregnant," senior study author Alison Gernand , associate professor of nutritional sciences at Penn State, added. “This study provides evidence that vitamin D appears to be an important part of a pregnant woman’s nutritional health," Gernand said. The research appears in the February issue of American Journal of Clinical Nutrition . Vitamin D is considered essential to health, and the body generates it naturally via the absorption of sunlight by the skin. However, many people no longer get enough vitamin D in their daily lives. In fact, prior research has found that “more than 25% of women who are pregnant or lactating have lower than recommended levels of vitamin D,” noted Gernand. “A lot of the development early in pregnancy requires vitamin D, so we conducted this study to better understand how early-pregnancy vitamin D status is related to pregnancy outcomes," she explained in a Penn State news release. Vitamin D insufficiency is defined as blood levels of the nutrient that are below 50 nanomoles per liter (nmol/L) of blood. In the new study, the researchers looked at first trimester vitamin D levels of 351 pregnant U.S. women who'd enrolled in a major federal study between 2010 and 2013. At first, there appeared to be no differences in pregnancy outcomes for women who were either above or below the 50 nmol/L blood level for vitamin D. But concerning differences did arise when researchers looked at a wider range of vitamin D concentrations. As Gerland and Beck reported, women with blood levels lower than 40 nmol/L during their first trimester had rates of preterm birth that were four times that of women who had vitamin D levels of 80 nmol/L or above. What's more, there was a trend to smaller babies (based on fetal length) among women as vitamin D levels during the first trimester decreased. The researchers stressed that these results are preliminary: There were few premature births in the study group overall, so a larger study may be needed to confirm the findings. Vitamin D levels during the second trimester appeared to have no relation to pregnancy outcomes. That could be because vitamin D levels tended to improve among the women later in pregnancy, although more study is needed to understand the finding, the researchers said. The take-home message from the study: Women may need to boost their vitamin D levels early in pregnancy. “Individual women may or may not need supplements depending on their diet and lifestyle," Gerland said. "But healthy nutrition is critical for promoting the healthy development of a fetus. This research indicates that vitamin D levels -- along with iron, folate and other essential nutrients in pregnancy -- should be monitored and understood by obstetricians and women early on to promote healthy birth outcomes.” The study was funded by the U.S. National Institutes of Health, the University of Utah and the Penn State Department of Nutritional Sciences. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

30 Dec 2024

·www.prnewswire.com

2025 Wellness Survey: Sauna Tops Recovery Practices People Want to Try; Building Muscle Remains Top New Year's Fitness Goal in Annual Life Time Poll

When asked about GLP-1 drugs, more than 60% believe the medications can improve overall health CHANHASSEN, Minn., Dec. 30, 2024 /PRNewswire/ -- As 2025 approaches, Life Time (NYSE: LTH) has released results from its annual health and wellness survey. More than 1,350 people participated, shedding light on 2025 goal setting and wellness trends for the New Year. Notable findings include: Continue Reading As 2025 approaches, Life Time has released results from its annual health and wellness survey. More than 1,350 people participated, shedding light on 2025 goal setting and wellness trends for the New Year. When asked which post-workout recovery practices people are interested in trying – or increasing – in 2025: 69.1% of respondents named using a sauna, while 50% said assisted stretching, and 42.4% chose ice baths or cryotherapy. When asked about GLP-1 drugs, 60.8% believe these medications have the potential to improve overall health. A high percentage (74.7%) plan to prioritize their health in 2025, compared to 62.4% of respondents who focused more on their health in 2024. A nearly 20% increase! 99.3% of respondents confirmed they feel happier after completing a workout, reinforcing the mental health benefits of getting your sweat on. For the third consecutive year, building muscle is the top health goal heading into the New Year, followed by eating better, moving more in general and weight loss. Strength training places as the top preferred workout routine, just ahead of cardio-focused workouts. "People of all ages are realizing the benefits of strength training and recovery by making it a priority in their routine," said Danny King, Director of Recovery and Performance at Life Time. "At Life Time, we're continuing to expand the size of our strength training spaces and recovery zones on our exercise floors, prioritizing equipment that fits a variety of body types and doubling down on our digital content. Our free Life Time Digital app is making it easier than ever for people to get started with strength training routines through classes and coaching at their fingertips." Survey respondents addressed 17 questions about their health, exercise habits, workouts and other topics: When it comes to nutrition, over 65% of respondents reported they don't follow a specific nutrition philosophy or eat intuitively. 59.5% of respondents take a supplement daily, with protein powder, multi-vitamins, and vitamin D being the most popular. Of those who take supplements, more than 60% said they take at least two to four daily. On learning about new nutrition and wellness trends, 48.6% prefer guidance from certified professionals, compared to 13% who rely solely on social media. When it comes to fitness apps, people most often use them for workouts, followed by data tracking, nutrition and meditation. More than 80% said they carve out at least several days a week with time dedicated to self-care and activities that make them happy. Unlike the traditional gym or club that is focused on selling and hoping you never use it, Life Time aims to be integral to daily life – a third place – to every member it serves. With more than three decades as a trusted and desirable brand, Life Time is a premier lifestyle, leisure and entertainment company. Regardless of your health and wellness goal in 2025, Life Time an array of programs and services for those 90 days old to 90 years old – from vast strength training floors to Dynamic Personal Training and Dynamic Stretch, to pickleball, tennis, cycle, Pilates, yoga and small-and large-group training, and athletic events you'll find it all here. For those on the go, Life Time also offers a free app with access to on-demand and livestreamed classes, coaching and wellness content from Experience Life magazine. The annual survey was conducted from Dec. 11 to Dec. 23 among general consumers and Life Time members. For more information about Life Time, visit or follow on social media at Facebook, Instagram and LinkedIn. About Life Time Life Time (NYSE: LTH) empowers people to live healthy, happy lives through its portfolio of more than 175 athletic country clubs across the United States and Canada. The health and wellness pioneer also delivers a range of healthy way of life programs and information, and the best curated products and LTH nutritional supplements via its complimentary Life Time Digital app. The Company's healthy living, healthy aging, healthy entertainment communities and ecosystem serve people 90 days to 90+ years old and is supported by a team of more than 41,000 dedicated professionals. In addition to delivering the best programs and experiences through its clubs, Life Time owns and produces nearly 30 of the most iconic athletic events in the country. SOURCE Life Time, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Colecalciferol

External Link

KEGG	Wiki	ATC	Drug Bank
D00188	Colecalciferol	A11CC05	DB00169

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Vitamin D Deficiency	China	Jiangsu Wuzhong Medicine Group Co., Ltd.	01 Jan 1987
Hypoparathyroidism	Canada	-	01 Jan 1985

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Osteoporosis, Postmenopausal	Phase 3	South Korea	Alvogen Korea Co., Ltd.	01 Dec 2011
Chronic heart failure	Phase 3	Italy	Abiogen Pharma SpA	01 Nov 2011
Hypercalcemia	Phase 3	Denmark	University of Aarhus	01 May 2008
Hyperparathyroidism, Primary	Phase 3	Denmark	University of Aarhus	01 May 2008
Crohn Disease	Phase 3	Denmark	University of Aarhus	01 Sep 2005
Lower urinary tract infectious disease	Phase 2	China	Zensun (Shanghai) Sci & Tech Co., Ltd.	08 May 2021
Osteoporosis	Phase 2	Denmark	University of Aarhus	01 Dec 2015
Rheumatoid Arthritis	Phase 2	Denmark	University of Aarhus	01 Dec 2015
Diabetes Mellitus, Type 2	Phase 2	Denmark	University of Aarhus	01 Dec 2008
Sarcopenia	Phase 1	United States	Metabolic Technologies, Inc.	01 Nov 2008

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01817166 (D-Lay MS, NEWS \| Pubmed) Manual	Phase 3	Multiple Sclerosis	316	cholecalciferol	fsyoxwirvm(czkqkpnnsh) = qtsyrbjnat cdtrrpvbav (dybuaiflrc ) View more	Positive	11 Mar 2025
				Placebo	fsyoxwirvm(czkqkpnnsh) = kufqnlpfrj cdtrrpvbav (dybuaiflrc ) View more
NCT02224144 (CTgov)	Phase 2	Bone Diseases, Metabolic \| Vascular Calcification \| Kidney Failure, Chronic ... View more	61	Calcitriol+Vitamin D3 (Vitamin D3 Plus Calcitriol)	tumjewykrq(eylilbhaun) = lenzhiqhpg uamcsfzdwy (adrqhoihfn, 0.54) View more	-	07 Mar 2025
				Placebo+Vitamin D3 (Vitamin D3 Plus Placebo)	tumjewykrq(eylilbhaun) = ouoagsmvpj uamcsfzdwy (adrqhoihfn, 0.46) View more
NCT01748448 (ViDMe, CTgov)	Phase 3	Melanoma, Cutaneous Malignant	436	Vitamin D (Vitamin D)	eomugynibj = gdzewjdgrz noeerngxvk (hgvhqlwaww, mzdsiyxkbs - hvhefwtbst) View more	-	17 Feb 2025
				Placebo: Oil (Placebo: Oil)	eomugynibj = ghousahzgn noeerngxvk (hgvhqlwaww, ytxobmefsq - baiplvevpw) View more
NCT01443728 (CTgov)	Phase 2	Asthma \| Vitamin D Deficiency \| Acute Chest Syndrome ... View more	70	Experimental: Vitamin D3 100,000 IU (Vitamin D3 100,000 IU)	ldyjipkwwa(awhyhzowon) = fmdeuadrrv hzybyvlksh (qtwjmjzvxd, 0.35) View more	-	09 Aug 2024
				Active Comparator: Vitamin D3 12,000 IU (Vitamin D3 12,000 IU)	ldyjipkwwa(awhyhzowon) = czktvwzyjg hzybyvlksh (qtwjmjzvxd, 0.35) View more
625-P (ADA2024)	Not Applicable	Diabetes Mellitus, Type 2 Vitamin D \| Thyroid function	730	Vitamin D (Lower VD group)	fokruhyesa(yrmndirudu) = uelzjsymut rpospeorck (lfprfmvdxv ) View more	Positive	14 Jun 2024
				Vitamin D (Higher VD group)	fokruhyesa(yrmndirudu) = fyimeggtvv rpospeorck (lfprfmvdxv ) View more
EULAR2024	Not Applicable	Systemic Lupus Erythematosus	-	Vitamin D (SLE Female Patients)	yqcwbcospo(jezmwazsoe) = ardtrryryx pxjjcnaskw (zoizyhzdci )	-	05 Jun 2024
				Vitamin D (Control Group)	yqcwbcospo(jezmwazsoe) = gmdodpjlgs pxjjcnaskw (zoizyhzdci )
EULAR2024	Not Applicable	Fibromyalgia Vitamin D levels	-	Vitamin D (Fibromyalgia Syndrome (FMS) patients)	iuabaygixp(vmqoyhuxla) = dbiiaeqamt dgdrvaulmf (noqyhcbdhp )	Positive	05 Jun 2024
				Vitamin D (Healthy individuals)	iuabaygixp(vmqoyhuxla) = loauoovgsk dgdrvaulmf (noqyhcbdhp )
NCT01169259 (VITAL, ENDO2024)	Phase 3	Diabetes Mellitus, Type 2	-	Vitamin D 2000 IU/d	xhngrpijlp(fykrvinkun) = vycbobghnh asggmajkck (mdlvsdnvii )	Negative	01 Jun 2024
				Vitamin D (Placebo)	xhngrpijlp(fykrvinkun) = aexcuvoktz asggmajkck (mdlvsdnvii )
ENDO2024	Not Applicable	Osteoporotic Fractures VDD \| serum 25OHD	-	vitamin D (Patients with hip fragility fractures)	fzqjdznpfx(krlsgchsiz) = kmyhbsnkjr qverhnijwa (yvlorthxsl )	-	01 Jun 2024
ENDO2024	Not Applicable	Hyperparathyroidism, Primary 1,25(OH)2 vitamin D \| FGF23	-	Vitamin D (PHPT patients)	vtndhshfsf(zijucedcaf) = xlfjqiqpef vtldnfpzci (lrmwyuaqhm ) View more	-	01 Jun 2024
				Vitamin D (Healthy individuals (CTRL))	vtndhshfsf(zijucedcaf) = fgulytpeqr vtldnfpzci (lrmwyuaqhm ) View more

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Colecalciferol

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