A Single-center, Randomized, Controlled, Double-blind Clinical Study to Evaluate the Effect of 6S-5-Methyltetrahydrofolate on Immunometabolic Function and Disease Activity in Ankylosing Spondylitis

Start Date24 Sep 2024

Sponsor / Collaborator-

NCT04974151

/ RecruitingPhase 4

Comparative Efficacy of Amlodipine Folic Acid Vs. Amlodipine on the Risk of First Ischemic Stroke Among Participants with Hypertension and MTHFR 677 TT Genotype: a Multi-center, Randomized, Double-blind, Triple-dummy, Controlled Clinical Trial

This is a multi-center, randomized, double-blind, triple-dummy, controlled trial in 24,000 Chinese men and women with hypertension and MTHFR 677 TT genotype.
The study participants will be randomized to one of the three treatment groups:
Group A: amlodipine tablet (5mg), taken orally, once daily, serving as active comparator.
Group B: amlodipine folic acid 5.8mg tablet (5mg amlodipine and 0.8mg folic acid), taken orally, once daily.
Group C: amlodipine folic acid 5.8mg tablet plus 5-methyltetrahydrofolate (5-MTHF, 0.4mg), taken orally, once daily.
The primary endpoint is first ischemic stroke.

Start Date22 Aug 2024

Sponsor / Collaborator

Shenzhen Ausa Pharmed Co. Ltd.

[+9]

NCT06218030

/ Not yet recruitingPhase 4IIT

PSIY-744-23: Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study

The goal of this feasibility study is to determine the tolerability and safety of add on treatment with L-methylfolate in patients with treatment-resistant generalized anxiety disorder (GAD). The primary objective is to monitor for side effects and other risks associated with the treatment. Secondary objectives are to compare the severity of symptoms, serum levels of folate, vitamin B12, C-reactive protein and homocysteine before and after treatment. Participants will continue with their usual treatment for GAD and receive add on treatment with L-methylfolate 15 mg per day for 8 weeks. All participants will receive the same intervention.

Start Date01 Apr 2024

Sponsor / Collaborator

Queen's University

100 Clinical Results associated with Levomefolate calcium

100 Translational Medicine associated with Levomefolate calcium

100 Patents (Medical) associated with Levomefolate calcium

613

Literatures (Medical) associated with Levomefolate calcium

01 Mar 2025·Animal Nutrition

Folic acid alleviates the negative effects of dexamethasone induced stress on production performance in Hyline Brown laying hens

Article

Author: Niu, Yuxin ; Wang, Chaohui ; Yang, Xiaojun ; Li, Yun ; Wang, Yumeng ; Sun, Xi ; Yang, Xin ; Liu, Yanli ; Li, Sijing ; Ren, Zhouzheng ; Liu, Xiaoying

Multiple stressors are believed to deteriorate production performance and cause substantial economic losses in commercial poultry farming. Folic acid (FA) is an antioxidant compound that can improve oocyte function and regulate gut microbiota composition. The current study was conducted to investigate the role of FA in alleviating stress and improving production performance. Sixty Hyline Brown laying hens at 21 weeks of age were randomly divided into three groups, with 10 replicates in each group and each replicate containing two chickens. Each group received basic diet and saline injection (Con group), basic diet with dexamethasone (DXM) injection (DXM group), or basic diet supplemented with FA (13 mg/kg in the premix) with DXM injection (FA group). The feeding trial lasted five weeks. Birds in the DXM and FA groups receiving subcutaneous DXM injections at a dosage of 4.50 mg/kg per day during the first seven days of the trial. Results showed that the levels of corticosterone, triglyceride, total cholesterol, and malondialdehyde in serum were significantly increased in the DXM group (P < 0.05), while the concentrations of FA and 5-methyltetrahydrofolate were decreased in the DXM group (P < 0.05). Laying hens in the DXM group had lower laying rates and egg quality, including egg weight, eggshell thickness, eggshell strength, albumen height, and Haugh units (P < 0.05). Conversely, FA alleviated these negative impacts. Through transcriptome analysis, a total of 247 and 151 differentially expressed genes were identified among the three groups, and 32 overlapped genes were further identified. Moreover, 44 and 59 differential metabolites were influenced by DXM and FA, respectively. Kyoto Encyclopedia of Genes and Genomes enrichment from the transcriptome and metabolomics showed that the reduced production performance may be due to the disturbance of oocyte production, calcium metabolism, and oxidative stress. Analysis of 16S rRNA gene amplicon sequences revealed the differential microbial composition and potential functional changes among the different groups. LEfSe analysis showed that Mucispirillum and Nautella were the predominant bacteria in the DXM group, while Clostridium was the predominant bacteria in the FA group. Functional prediction demonstrated that stressors enhanced fatty acid biosynthesis, while betaine biosynthesis and retinol metabolism were elevated in the FA group. Dietary FA reversed the elevated levels of bile acids (BA), including cholic acid, taurodeoxycholic acid, and taurochenodeoxycholic acid (P < 0.05). The DXM group showed an overall decrease in short-chain fatty acids (SCFA), but FA restored the concentrations of acetic acid, propionic acid, and isobutyric acid (P < 0.05). In conclusion, this study reveals that dietary FA can alleviate the degradation of production performance caused by stress through improving circulating antioxidant capacity, maintaining intestinal microbiota homeostasis, and regulating SCFA and BA biosynthesis. Thus, highlighting the prominent role of gut microbe-host interactions in alleviating multi-stresses.

01 Jan 2025·3 Biotech

5-Methyltetrahydrofolate and aqueous extract of Spirulina (Arthrospira) ameliorate diabetes and associated complications in STZ-induced diabetic rats

Article

Author: Prasanthan, Aparna ; Bhaskar, T Krishna ; Haritha, P K ; Puthusseri, Bijesh ; Pathikkal, Ajana ; Rudrappa, Sudha ; Chauhan, Vikas Singh

The present study evaluated the effects of 5-methyltetrahydrofolate (5-MTHF) and Spirulina aqueous extract on diabetes. An in silico docking study with select Spirulina bioactive compounds showed strong binding affinities of folates with glucose metabolism-related proteins. In vitro assay showed 5-MTHF's superior inhibitory activity on alpha-amylase compared to folic acid. The protective effect of Spirulina aqueous extract and 5-MTHF were validated in vivo using an STZ-induced diabetic Wistar rat model. Supplementation with Spirulina extract through diet, and a higher dose of 5-MTHF through gavage effectively lowered fasting blood glucose levels and improved oral glucose tolerance and amylase content. Supplementation also countered hyperlipidemia, improved the levels of antioxidant enzymes, and reduced the inflammatory markers. Weight loss prevention, mitigation of kidney enlargement, and normalisation of the histology of the pancreas, kidney, and liver were also observed. The ameliorative effect of a higher dose of 5-MTHF was comparatively superior to Spirulina aqueous extract and a corresponding higher dose of folic acid. An increase in serum folate levels on supplementation with Spirulina aqueous extract suggests Spirulina to be a source of bioavailable folate. The positive effect of Spirulina aqueous extract suggests a potential synergistic role for folate along with its other bioactive phytochemicals. The study highlights the potential ameliorative effects of Spirulina aqueous extract and 5-MTHF as a dietary supplement on diabetes and associated complications.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13205-024-04170-9.

01 Jan 2025·Journal of Food Science

A review of enhancing noodle quality: Fortification with micronutrients and substitution with nutrient‐dense alternative

Review

Author: Ayustaningwarno, Fitriyono ; Anjani, Gemala ; Suryaputra, Aditya

AbstractNoodles are usually rich in carbohydrates but lack essential nutrients such as protein, fiber, vitamins, and minerals, potentially causing metabolic problems if consumed in the long term. This review explores strategies to improve the quality of noodles through substitution and fortification. Substitution is replacing the main ingredient with a more nutrient‐dense alternative, such as sweet potato starch, which has been shown to improve the nutritional content of noodles, such as fiber and beta carotene. Meanwhile, fortification is the addition of micronutrients to food products to restore or enhance levels of micronutrients that are not present in the food, which is usually done during the production process. However, substitution and fortification have their challenges. The substitution method usually causes a decrease in the physical quality of the noodles due to changes in the raw materials, thus reducing consumer acceptance of the final product. Meanwhile, fortified nutrients usually undergo considerable degradation during production, reducing their effectiveness. Further research and development should focus on new methods to help maintain physical quality while minimizing the loss of fortified or substituted nutrients. Technological approaches such as microencapsulation have proven effective in maintaining the stability of micronutrients such as L‐5‐methyltetrahydrofolate added during production. The methods of cold plasma, γ‐irradiation, and multifrequency ultrasound, as well as the addition of xanthan gum and guar gum, are able to improve the moisture level, color, texture, elasticity, and chewiness, as well as consumer sensory acceptance. This technology enables manufacturers to meet customer demand for quality and nutritious noodle options.

News (Medical) associated with Levomefolate calcium

02 Jan 2024

·synapse.patsnap.com

Exploring MR antagonists: What They Are and How to Keep Up with the Latest Advances

The role of the MR (Mineralocorticoid Receptor) in the human body is crucial for maintaining electrolyte and fluid balance. MR is a type of receptor found in various tissues, including the kidneys, heart, and brain. When activated by the hormone aldosterone, MR regulates the reabsorption of sodium and water in the kidneys, leading to increased blood volume and blood pressure. This receptor also plays a role in regulating potassium levels and maintaining the balance of electrolytes. Dysfunction of the MR can lead to conditions such as hypertension, electrolyte imbalances, and cardiovascular diseases. Understanding the role of MR is essential for developing targeted therapies in the pharmaceutical industry. Based on the analysis of the target MR, it is evident that Bayer AG and Pfizer Inc. are among the companies growing fastest in this field. The R&D progress of these companies, along with oOh!media Group Pty Ltd., Daiichi Sankyo Co., Ltd., CMP Development LLC, Estetra SPRL, and China National Pharmaceutical Group Co., Ltd., is promising. The approved indications cover a wide range of therapeutic areas, indicating the diversity of research in the target MR. Small molecule drugs dominate the development phases, suggesting intense competition in this area. The involvement of various countries/locations, including China, highlights the global nature of the target MR. Overall, the current competitive landscape indicates a promising future for the development of drugs under the target MR. How do they work?MR antagonists, also known as mineralocorticoid receptor antagonists, are a class of drugs that block the action of the mineralocorticoid receptor. The mineralocorticoid receptor is a protein found in various tissues, including the kidney, heart, and brain, and it plays a crucial role in regulating electrolyte balance and blood pressure. From a biomedical perspective, MR antagonists are primarily used in the treatment of conditions such as hypertension (high blood pressure) and heart failure. By blocking the mineralocorticoid receptor, these drugs inhibit the effects of aldosterone, a hormone that promotes sodium and water retention and potassium excretion. This leads to a reduction in fluid volume and blood pressure, helping to manage hypertension and improve symptoms in heart failure patients. Common examples of MR antagonists include spironolactone and eplerenone. These drugs are typically prescribed in combination with other medications to optimize blood pressure control and manage fluid balance in patients with cardiovascular disorders. It's important to note that MR antagonists should be used under medical supervision, as they can have potential side effects and interactions with other medications. Close monitoring of electrolyte levels, particularly potassium, is necessary during treatment with MR antagonists to prevent imbalances. List of MR AntagonistsThe currently marketed MR antagonists include: FinerenoneDrospirenoneEsaxerenoneVistaMRDrospirenone/Ethinyl Estradiol/Levomefolate CalciumDrospirenone/EstetrolDrospirenone/EstradiolEplerenoneDrospirenone/Ethinyl EstradiolFludrocortisone AcetateFor more information, please click on the image below. What are MR antagonists used for?MR antagonists are primarily used in the treatment of conditions such as hypertension (high blood pressure) and heart failure. For more information, please click on the image below to log in and search. How to obtain the latest development progress of MR antagonists?In the Synapse database, you can keep abreast of the latest research and development advances of MR antagonists anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

02 Aug 2023

·www.drugs.com

Some Lots of Tydemy Birth Control Pills Recalled Due to 'Reduced Effectiveness'

WEDNESDAY, Aug. 2, 2023 -- Certain lots of the prescription birth control pill Tydemy may be less effective than expected, potentially resulting in an unintended pregnancy, because the pills do not contain enough of an active ingredient. The U.S. Food and Drug Administration warned consumers about the issue Tuesday following a company announcement about the issue on July 29. Two lots of Tydemy (drospirenone/ethinyl estradiol/levomefolate calcium) made by Lupin Pharmaceuticals do not contain the correct level of ascorbic acid, the FDA noted. Lots L200183 and L201560, in 28-dose blister packs, were distributed throughout the United States between June 3, 2022, and May 31, 2023. "To date, Lupin has received no reports of adverse events related to either recalled batches," the company noted. "Regardless, Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content (ascorbic acid), this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy." Patients should continue taking their medication, the FDA said, but they should also immediately contact their health care provider for advice about an alternative method of birth control. The company had previously voluntarily recalled the two lots of Tydemy at the wholesale level. "Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 9:00 a.m. to 5:00 p.m. EST," Lupin instructed in its statement. "For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.; the lot number can be found on the side of the carton." The FDA also encouraged health care providers and patients to report any adverse events or quality problems with this or other medications to the agency’s MedWatch Adverse Event Reporting program. Sources U.S. Food and Drug Administration, Aug. 1, 2023 Posted August 2023

02 Aug 2023

·www.pharmaceutical-technology.com

FDA warns of reduced efficacy for oral birth control pill Tydemy

Phalguni Deswal @Phalguni_GD The US FDA recently approved Perrigo’s Opill (norgestrel), which does not require a prescription. Credit: Africa Studio / Shutterstock. The US Food and Drug Administration (FDA) has issued a customer warning for Lupin Pharmaceuticals’ oral birth control pill Tydemy. The FDA warns of reduced efficacy of Tydemy due to decreased levels of one of the inactive ingredients, ascorbic acid. Recommended Reports Reports LOA and PTSR Model - Zoliflodacin in Uncomplicated Cervical And Urethral Gonorrhea GlobalData Reports LOA and PTSR Model - Palonosetron Hydrochloride La in Chemotherapy Induced Nausea and Vomiting GlobalData View all Companies Intelligence Lupin Ltd Perrigo Company Lupin Pharmaceuticals Inc NDC View all The reduced efficacy is associated with two US lots, L200183 (expiry date January 2024; NDC Number 68180-904-71) and L201560 (expiry date September 2024; NDC Number 68180-904-73) distributed from 3 June 2022 to 31 May 2023. On 28 July, Lupin issued a voluntary recall for the two lots following an out-of-specification (OOS) test reporting low levels of ascorbic acid and high levels of a known impurity in the L200183 lot. Tydemy (drospirenone / ethinyl estradiol / levomefolate calcium) is a prescription oral contraceptive that prevents pregnancy by raising folate levels. As per Lupin ’s 28 July press release , the reduction in ascorbic acid could impact Tydemy’s efficacy and could lead to an unexpected pregnancy. The US FDA recently approved Perrigo’s Opill (norgestrel) , which does not require a prescription, while many other contraceptives such as Tydemy need one. Global sales of contraceptives are expected to reach £8.2bn by 2027, as per GlobalData forecasts. GlobalData has also identified an unmet need for hormone-free birth control pills. To that end, Singapore-based Navad Life Sciences is developing an oestrogen-free oral contraceptive , NA-0113, which is currently in a Phase II trial. GlobalData is the parent company of Pharmaceutical Technology . Other women’s health drug in Lupin’s pipeline includes Solosec (secnidazole), which is marketed for bacterial vaginosis.

Drug ApprovalPhase 2Phase 3

100 Deals associated with Levomefolate calcium

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KEGG	Wiki	ATC	Drug Bank
D09354	Levomefolate calcium	B03A	DB11256

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Dietary Supplement	United States	Merck KGaA	23 Nov 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Angelman Syndrome	Preclinical	United States	Rady Children's Hospital-San Diego	01 Dec 2011
Angelman Syndrome	Preclinical	United States	National Institutes of Health	01 Dec 2011
Angelman Syndrome	Preclinical	United States	University of California	01 Dec 2011
Contraception	Discovery	Netherlands	Bayer AG	01 Oct 2006

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAN2018	Not Applicable	MTHFR mutations \| folate metabolism	146	l-methylfolate calcium 15mg	(abomwtyqgu) = Rates of laboratory abnormalities did not differ significantly between populations (p=0.13) qggoenkrja (mnqddpidaw )	Positive	10 Apr 2018
				l-methylfolate calcium 7.5mg
NCT01853280 (CTgov)	Phase 2/3	Attention Deficit Disorder With Hyperactivity	47	L-methylfolate+OROS-Methylphenidate	yihzlqvqmt(guahuneuia) = emuzejedpf vffczxsird (jcjgoijlzk, hjlbdzocss - qmapsvqfgd) View more	-	14 Nov 2017
NCT00348933 (CTgov)	Not Applicable	Angelman Syndrome	90	Metafolin+B12+Creatine+Betaine (Treatment (Metafolin/Creatine/Betaine/B12))	jkzsvrubtj(bduhwrtbgc) = rjddttcjni mgmanoauat (deogrbmprq, hienkvfscu - klclsvfcne) View more	-	24 Sep 2012
				Metafolin (Treatment (Metafolin/Creatine/Betain/B12))	knmhbxiemu(oeorpjgmgh) = qdlmsbepal bkeuyuigyw (ismegitgjn, dorcotihxh - bzemodgaqg) View more

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