An Interventional, Prospective Open-Label Study of Immunosuppressive Therapies to Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia (RESTORE)

The primary objective of this study is to evaluate the effect of immunosuppressive therapy (IST) in participants treated with asfotase alfa who demonstrate immune-mediated loss of effectiveness (LoE).

Start Date02 Jul 2025

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

ChiCTR2500099627

/ SuspendedPhase 4IIT

A randomized controlled study of the efficacy and safety of folic acid in the development of atrophic gastritis

Start Date07 Apr 2025

Sponsor / Collaborator-

NCT06774885

/ Not yet recruitingPhase 3IIT

ROLE OF FOLIC ACID IN THE MANAGEMENT OF ADJUVANT ENDOCRINE THERAPY-INDUCED HOT FLASHES IN BREAST CANCER PATIENTS

The study's objective is to investigate the role of folic acid administration in the management of hot flashes associated with adjuvant endocrine therapy in patients with breast cancer.

Start Date09 Feb 2025

Sponsor / Collaborator

Future University in Egypt

100 Clinical Results associated with Folic Acid

100 Translational Medicine associated with Folic Acid

100 Patents (Medical) associated with Folic Acid

67,706

Literatures (Medical) associated with Folic Acid

31 Dec 2025·GYNECOLOGICAL ENDOCRINOLOGY

Early gestational diabetes mellitus risk predictor using neural network with NearMiss

Article

Author: Su, Xiaojie ; Huang, Lihong ; Zhao, Min

BACKGROUND:

Gestational diabetes mellitus (GDM) is globally recognized as a significant pregnancy-related condition, contributing to complex complications for both mothers and infants. Traditional glucose tolerance tests lack the ability to identify the risk of GDM in early pregnancy, hindering effective prevention and timely intervention during the initial stages.

OBJECTIVE:

The primary objective of this study is to pinpoint potential risk factors for GDM and develop an early GDM risk prediction model using neural networks to facilitate GDM screening in early pregnancy.

METHODS:

Initially, we employed statistical tests and models, including univariate and multivariate logistic regression, to identify 14 potential risk factors. Subsequently, we applied various resampling techniques alongside a multi-layer perceptron (MLP). Finally, we evaluated and compared the classification performances of the constructed models using various metric indicators.

RESULTS:

As a result, we identified several factors in early pregnancy significantly associated with GDM (p < 0.05), including BMI, age of menarche, age, higher education, folic acid supplementation, family history of diabetes mellitus, HGB, WBC, PLT, Scr, HBsAg, ALT, ALB, and TBIL. Employing the multivariate logistic model as the baseline achieved an accuracy and AUC of 0.777. In comparison, the MLP-based model using NearMiss exhibited strong predictive performance, achieving scores of 0.943 in AUC and 0.884 in accuracy.

CONCLUSIONS:

In this study, we proposed an innovative interpretable early GDM risk prediction model based on MLP. This model is designed to offer assistance in estimating the risk of GDM in early pregnancy, enabling proactive prevention and timely intervention.

31 Dec 2025·Journal of the International Society of Sports Nutrition

Survey of nutritional intake status in college baseball players

Article

Author: Aoyama, Yuka ; Tanaka, Mamoru ; Seguchi, Manato ; Iio, Yoko ; Kozai, Hana ; Mori, Yukihiro ; Ito, Morihiro

BACKGROUND:

Diet is closely related to exercise performance. To improve athletes' performance and manage their condition, it is important to get sufficient energy and various nutrients. Thus, it is necessary that athletes understand their nutritional intake status to improve performance and maintain health. This study aimed to explore the nutritional intake status of college baseball players using the Food Frequency Questionnaire (FFQ). Furthermore, the characteristics of their nutritional intake status with respect to athletic performance were evaluated. The result of this studyprovide an opportunity for many under-developed college athletes with irregular lifestyles to recognize and improve their nutritional problems.

METHODS:

In October 2022, a questionnaire survey of 116 male members of a college baseball club was conducted. Of whom, 100 (94.3%) members responded to the survey and 92 (92.0%) provided valid responses. The survey items included basic characteristics such as college grade and type of living arrangement, and information on living conditions, e.g. whether the participant ate breakfast. Nutritional intake was evaluated using the FFQ. Players were divided into the first (regular players in official games), second (bench players in official games), third (players who may join the second or higher team in the future), and fourth teams (players who do not belong to the first to third teams); these categories were used as a marker of performance level. The Kruskal-Wallis test was used to analyze the association between the performance levels of baseball players and the intake of each nutrient and food group obtained by the FFQ. For items that showed a significant association, inter-group comparison was performed using the Dunn-Bonferroni method.

RESULTS:

Carbohydrate intake was greater in the second team compared with the third and fourth teams; saturated and monounsaturated fatty acid intake was higher in the third team compared with the fourth team. Calcium, zinc, copper, manganese, insoluble dietary fiber, iodine, and molybdenum intake was higher in the second team compared with the fourth team. Intake of grains, sugar, dairy, and total energy was significantly higher in the second team compared with the fourth team. However, the protein intake ratio was significantly lower in the second team compared with the fourth team. Overall, energy deficiency and associated deficiencies in protein, fat, and carbohydrate were observed, in addition to dietary fiber and calcium deficiencies. The intake of several food groups appeared inadequate, such as potatoes, beans, vegetables, fruits, eggs, milk, and fats.

CONCLUSIONS:

The study showed deficiencies in the amount of energy and nutrients such as protein, fat, and carbohydrate in college baseball players. Differences in the intake of carbohydrate, calcium, and insoluble dietary fiber among different performance levels were observed, with significantly higher intake of carbohydrate, calcium, and insoluble dietary fiber in the second team. Implementing organized and strategic remedial measures and athletes' identification of nutritional problems are vital to overcome nutritional and energy deficiencies. This study provides useful information for the development of strategies to support nutritional intake in college baseball players.

01 Dec 2025·Genes and Nutrition

Impact of single nucleotide polymorphisms (SNPs) in antioxidant-enzyme genes on the concentrations of folate, homocysteine and glutathione in plasma from healthy subjects after folic acid supplementation – a randomized controlled crossover trial

Article

Author: Slettan, Audun ; Cabo, Rona ; Mansoor, Mohammad Azam ; Blomhoff, Rune ; Kottahachchi, Darshana ; Ali, Dhikra Saleem ; Stea, Tonje Holte ; Perera, Erandie ; Maddumage, Ridmi

Abstract:

Background:

One-carbon metabolism links folate and methionine metabolism and this is essential for nucleotide synthesis in the cells. Alterations in one-carbon metabolism are associated with cardiovascular disease (CVD), type 2 diabetes and cancer. Our aim was to investigate whether SNPs in antioxidant-enzyme genes impact the concentrations of folate in serum (s-folate), plasma total homocysteine (p-tHcy) and total glutathione in plasma (p-tGSH) in healthy subjects after supplementation with folic acid.

Methods:

In a randomized, double blind, crossover study, healthy subjects received 0.8 mg folic acid per day or a placebo for two weeks. Twenty-four male, and sixty-seven female subjects participated in this study. Participants were aged 36.4 ± 14.8 years (mean ± SD). We studied SNPs in six genes by PCR methods. The concentrations of s-folate, p-tHcy and p-tGSH were measured in fasting samples with Cobas and an HPLC-fluorescence method. Student T-tests and ANOVA were used for the statistical calculations.

Main findings:

The subjects with SNP (rs4880) in superoxide dismutase (SOD2) gene (CC) allele had higher concentrations of s-folate and lower concentrations of p-tHcy than subjects with (CT + TT) alleles, (p = 0.014 and p = 0.012). Contrary to SOD2 (CC) allele, the subjects with SNP (rs1001179) catalase (CAT) CC allele had lower concentrations of s-folate (p = 0.029), higher concentrations of p-tGSH (0.017) and higher concentrations of p-tHcy before and after folic acid supplementations (p = 0.015, p = 0.017) than the subjects with (CT + TT) allele. Glutathione transferase (theta)1 (GST-T1) genotype was associated with higher concentrations of s-folate than GST-T0 before (p = 0.025) and after folic acid supplementation (p = 0.047). SNP (rs1050450) in glutathione peroxidase (GPX1) had also impact on the concentrations of p-tGSH (p = 0.011) in healthy subjects.

Conclusion:

SNPs in SOD2 (rs4880), CAT (rs1001179), and GST1 impact the concentrations of s-folate, and p-tHcy in healthy subjects before and after folic acid supplementation. Our findings suggest that SNPs in antioxidant-genes have a role in health and disease by impacting the concentrations of s-folate, p-tHcy and p-tGSH.

News (Medical) associated with Folic Acid

04 Mar 2025

·www.prnewswire.com

Are higher doses of folic acid in pregnancy safe?

MINNEAPOLIS, March 4, 2025 /PRNewswire/ -- Taking a higher dose of folic acid during the first trimester of pregnancy was safe and associated with improved verbal abilities in children at age six as well as improved behavior skills, according to a preliminary study released March 4, 2025, that will be presented at the American Academy of Neurology's 77th Annual Meeting taking place April 5–9, 2025, in San Diego and online. "Folic acid during pregnancy has been shown to reduce deformities and improve intellectual abilities in children, but the best dose of folic acid is unknown," said study author Kimford J. Meador, MD, PhD, of Stanford University in Palo Alto, California, and a Fellow of the American Academy of Neurology. "Our study provides new information showing a positive connection between taking folic acid during early pregnancy and brain health outcomes in children, with no evidence of negative effects at higher doses." The study looked at 345 children when they were six years old. Of the participants, 262 were children of women with epilepsy and 83 were children of women without epilepsy. Researchers recorded doses of folic acid taken by their mothers during the first 12 weeks of pregnancy and divided the children into five groups based on average dosage: no folic acid, folic acid up to 0.4 milligrams (mg) per day; more than 0.4 to 1.0 mg per day; more than 1.0 to 4.0 mg per day; and more than 4.0 mg per day. The current recommended dose during pregnancy for the general population is 0.4 mg per day, while women with epilepsy may be prescribed a higher dose. Children were given multiple tests to assess verbal skills. For example, for one vocabulary test, participants were asked to describe objects, actions or concepts presented in each picture using one word. For the general population, scores for these verbal tests range from 70 to 130, with a mean of 100, with higher scores indicating better abilities. Parents also completed questionnaires to assess the children's behaviors like communication skills, social skills and daily living skills. Results from these tests were combined for an overall standardized behavioral score. For the general population, scores range from 70 to 130, with a mean of 100, with higher scores indicating better abilities. After adjusting for factors such as mother's IQ, epilepsy medications, and pregnancy complications, researchers found the average verbal score for children of women who took folic acid was 108 compared to 96 for children of women who did not take folic acid. The average behavioral score for children of women who took folic acid was 102 compared to 82 for children of women who did not take folic acid. When looking only at children whose mothers took folic acid during pregnancy, researchers found scores were similar across low to high doses of folic acid. Children of mothers who took a low dose had a similar average verbal score of 110 compared to 108 for children of mothers who took a high dose. Children of those who took a low dose and children of those who took a high dose both had average behavioral scores of 103. "While previous studies have found risks with higher doses, these findings are reassuring for people who are pregnant or planning to have children that taking a higher dose of folic acid early in pregnancy may still positively impact the brain health of their child," Meador said. "Additional studies are needed to determine the best dose of folic acid to maximize benefits and minimize risks to neurodevelopment as well as other outcomes, which could vary for different groups of women." A limitation of the study was that it did not look at other factors that may affect folic acid intake and absorption, such as other vitamins taken and genetics. The study was supported by the National Institute of Neurological Disorders and Stroke and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Discover more about brain health at BrainandLife.org, from the American Academy of Neurology. This resource also offers a magazine, podcast, and books that connect patients, caregivers and anyone interested in brain health with the most trusted information, straight from the world's leading experts in brain health. Follow Brain & Life® on Facebook, X, and Instagram. The American Academy of Neurology is the leading voice in brain health. As the world's largest association of neurologists and neuroscience professionals with more than 40,000 members, the AAN provides access to the latest news, science and research affecting neurology for patients, caregivers, physicians and professionals alike. The AAN's mission is to enhance member career fulfillment and promote brain health for all. A neurologist is a doctor who specializes in the diagnosis, care and treatment of brain, spinal cord and nervous system diseases such as Alzheimer's disease, stroke, concussion, epilepsy, Parkinson's disease, multiple sclerosis, headache and migraine. Explore the latest in neurological disease and brain health, from the minds at the AAN at AAN.com or find us on Facebook, X, Instagram, LinkedIn, and YouTube. SOURCE American Academy of Neurology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical Result

03 Dec 2024

·www.drugs.com

Two Common Antiseizure Medications Do Not Harm Child Neurodevelopment

TUESDAY, Dec. 3, 2024 -- Fetal exposure to two common antiseizure medications (ASMs) does not seem to negatively impact children's neurological development at age 6 years, according to a study published online Nov. 25 in JAMA Neurology . Kimford J. Meador, M.D., from the Stanford University School of Medicine in Palo Alto, California, and colleagues compared the outcomes of 6-year-old children of women with epilepsy (WWE) versus those of healthy women to assess the association of outcomes to third-trimester ASM exposures. The analysis included 298 children of WWE and 89 children of healthy women. The researchers found that the two groups of children did not differ on the Verbal Index Score, but there was variance based on the amount of ASM exposure. Lamotrigine showed positive exposure-dependent associations, while levetiracetam showed negative exposure-dependent associations. Across ASMs, exposure-dependent outcomes differed. Three-quarters of WWE (78 percent) were taking lamotrigine or levetiracetam alone or in combination, so assessment of other ASMs was limited. There were positive associations for folate supplementation during the first 12 weeks of pregnancy with cognition and behavior, with no signal for risks at higher folate doses. "Because all ASMs are potential teratogens, and teratogens act in an exposure-dependent manner, the clinical challenge is to provide a dose sufficiently high to protect the mother and fetus from seizures but at the lowest effective concentration to minimize fetal risks," the authors write. Several authors disclosed ties to the pharmaceutical industry.

Clinical Result

14 Nov 2024

·fabrydiseasenews.com

Boy with Fabry disease diagnosed with co-occurring blood disorder

A 10-year-old boy diagnosed with Fabry disease was also found to have a rare blood disorder called congenital dyserythropoietic anemia (CDA) in a case researchers said was highly unusual.In CDA, anemia, that is, a shortage of red blood cells that transport oxygen in the bloodstream, results in symptoms like fatigue, weakness, and pale skin.“CDA … and [Fabry disease] co-occurring in the same patient is a very rare medical finding [that] has never been reported,” the researchers wrote. “This case … underscores the need for further investigation into potential genetic and [disease-causing] links between these seemingly disparate conditions.”The case was described in “The unlikely combination: Anderson–Fabry disease and congenital dyserythropoietic anemia type II in a pediatric patient,” in Clinical Case Reports.The boy was started on treatment with agalsidase alfa, an enzyme replacement therapy for Fabry, but no follow-up data regarding his treatment outcomes was provided.Fabry disease is caused by mutations in the GLA gene, which provides instructions for producing the alpha-galactosidase A (alpha-Gal A) enzyme. The mutations typically affect the activity of alpha-Gal A and lead to fat molecules — mainly globotriaosylceramide (Gb3) and lyso-Gb3 — accumulating in several tissues and organs. Symptoms include pain, gastrointestinal issues, and skin rash, and may involve the kidneys, heart, and nervous system.The boy was admitted to a pediatric clinic having had a pale appearance and recurrent infections in the previous months. A physical exam showed his vital signs were stable and he had normal growth, but an ultrasound revealed an enlarged spleen.Laboratory work indicated low hemoglobin, the protein that carries oxygen in red blood cells, and high levels of total bilirubin, although direct bilirubin was in the normal range. Total bilirubin includes indirect bilirubin, the one that results from the breakdown of red blood cells, and direct bilirubin, an indicator of liver function.The boy had ferritin levels that were just above the lower normal range. Ferritin is a protein that stores iron needed to make healthy red blood cells. The boy was treated with folic acid and iron supplements, which didn’t significantly increase his hemoglobin or reduce the levels of total bilirubin.Whole genome sequencing, which allows for the sequencing of a person’s complete genetic information, revealed genetic mutations consistent with Fabry disease, which, together with lower than normal alpha-GalA activity confirmed the disease diagnosis.The boy also had a mutation that led to a CDA type 2 diagnosis. This CDA type is the most common one and is marked by anemia, and liver and spleen enlargement. He was referred to a pediatric neurologist and started treatment with agalsidase alfa every two weeks. Agalsidase alfa is an enzyme replacement therapy, meaning it provides a working version of the alpha-Gal A enzyme to ease Fabry symptoms. The treatment is approved as Replagal in Europe and other countries, but not in the U.S.No information about the result of treatment was provided by the researchers.“The combined form of both entities of disorders isn’t widely known. Since both CDA and [Fabry disease] are rare genetic disorders, the likelihood of an individual having both conditions simultaneously is exceedingly low,” the researchers wrote. “To the best of our knowledge, it is the first case of [Fabry disease] and CDA type II, coexisting in a 10-year-old boy.”

Drug ApprovalClinical Result

100 Deals associated with Folic Acid

External Link

KEGG	Wiki	ATC	Drug Bank
D00070	Folic Acid	V04CX02 B03BB01	DB00158

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia, Megaloblastic	China	Tianjin Lisheng Pharmaceutical Co., Ltd.	01 Jan 1981
Folic Acid Deficiency	Japan	Fuji Pharma Co., Ltd.	01 Aug 1950
Neural Tube Defects	United States	Eli Lilly & Co.	02 Jun 1947

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Contraception	Phase 1	-	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Jan 2005
Ischemic stroke	IND Approval	China	Beijing Silian Pharmaceutical Co., Ltd.	24 Sep 2024
Homocysteinemia	IND Approval	China	Beijing Silian Pharmaceutical Co., Ltd.	09 Nov 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADA2024	Not Applicable	Diabetes Mellitus, Type 2	-	Folic AcidFolateAcid (Folate supplementation)	xlyahfjubv(rfygxfhjfz) = mpgmogvuex wlatqiqazi (rtoauboeln, -1.74 to -0.78)	-	14 Jun 2024
IEC2023	Not Applicable	-	-	High-dose folic acid	rlquekxtak(zxqwrpmrkj): aHR = 0.8 (95% CI, 0.63 - 1.02)	Positive	04 Sep 2023
				No high-dose folic acid
NCT04354428 (CTgov)	Phase 2/3	COVID-19	289	Ascorbic Acid+Folic Acid (Ascorbic Acid and Folic Acid)	swyprhxetg = ivyfjobhpf bgoiyglhzz (gisbvjwcsw, wjccamfgiq - luefyhvefg) View more	-	08 Aug 2022
				Hydroxychloroquine Sulfate+Folic Acid (Hydroxychloroquine and Folic Acid)	swyprhxetg = hlhmfkkrhv bgoiyglhzz (gisbvjwcsw, pwoseoazqg - nxzlozgucl) View more
EULAR2022	Not Applicable	COVID-19	-	Folic acid only	-	-	01 Jun 2022
				Methotrexate and folic acid
NCT03994731 (MIRROR RCT \| MIRROR, CTgov)	Phase 4	Gout	152	gout flare prophylaxis regimen+acetaminophen+methylprednisolone+fexofenadine+folic acid+methotrexate+Pegloticase (Pegloticase + MTX)	psidqobcfp = fzezqspzeg whwgnyqeml (bfekgqcjhe, toczfeyajj - camrtmyqwe) View more	-	16 May 2022
				placebo+acetaminophen+methylprednisolone+fexofenadine+folic acid+methotrexate+Pegloticase (Pegloticase + Placebo)	psidqobcfp = dykelvcibq whwgnyqeml (bfekgqcjhe, byhjloqgtv - loyjwruevm) View more
NCT00950989 (CTgov)	Phase 2	Rheumatoid Arthritis	252	Placebo+folic acid+methotrexate (Placebo)	rwiaocdxkm = jaiceaxqkh opphbbuveo (bdaagxfuqh, twkcxzwhtw - vkopqwujyx) View more	-	21 Dec 2021
				Brodalumab+folic acid+methotrexate (Brodalumab 70 mg)	rwiaocdxkm = vimebpliuh opphbbuveo (bdaagxfuqh, cfegxiitfb - kjkuxbhlpk) View more
ASN2021	Not Applicable	Fibrosis mitochondrial DNA \| cGAS \| STING	23	Folic Acid (Goldenticket (Gt) mice)	qwftuqqikw(shqvbzwins) = kasikkjayn kebqmhdpkp (cvhzbmajft ) View more	Negative	27 Oct 2021
				Folic Acid (Wild type (WT) mice)	qwftuqqikw(shqvbzwins) = imuiacrefa kebqmhdpkp (cvhzbmajft ) View more
NCT02930343 (CTgov)	Phase 3	Rheumatoid Arthritis	136	Hydroxychloroquine+Folic Acid+Prednisolone+Methotrexate+Leflunomide (Group 1- MTX+LEF+HCQ)	dtrdkiwrsj = srlikvxtnt ubznobijvk (kpekzskbqa, ysqrpdfavz - svfblmsfyf) View more	-	10 Jun 2021
				Hydroxychloroquine+Folic Acid+Prednisolone+Sulfasalazine+Methotrexate (Group 2- MTX+SSZ+HCQ)	dtrdkiwrsj = wpvzcuisfn ubznobijvk (kpekzskbqa, hlpqxfddye - qohzeoyiod) View more
NCT03172325 (CTgov)	Phase 3	Rheumatoid Arthritis	136	Adalimumab+Folic Acid+Prednisolone+Methotrexate (CinnaGen Adalimumab)	vpgonsahww = tgfcvwmfpo ezpwoiickj (qmiwbujgzo, zbbrygmtau - uiftdwntno) View more	-	02 Feb 2021
				Adalimumab+Folic Acid+Prednisolone+Methotrexate (AbbVie Adalimumab)	vpgonsahww = gbhlexmtza ezpwoiickj (qmiwbujgzo, imutotgtho - pmhfkekexn) View more
NCT03635957 (MIRROR OL \| MIRROR-OL \| MIRROR, CTgov)	Phase 4	Gout	14	Infusion Reaction (IR) Prophylaxis+Folic Acid+Methotrexate (MTX)+Pegloticase	vefibijvia = jrrgdrjfjf xsktolutxx (uypnsucbpw, lqqqbazcaw - fwqtpqtixe) View more	-	18 Nov 2020

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