alexa A Randomized, Placebo-Controlled Trial in Women of Chil
ISSN: 2376-1318

Vitamins & Minerals
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Research Article

A Randomized, Placebo-Controlled Trial in Women of Childbearing Age to Assess the Effect of Folic Acid and Methyl-Tetrahydrofolate on Erythrocyte Folate Levels

Ella Schaefer*, Gregor Bieri, Ozgur Sancak, Luca Barella and Silvia Maggini
Bayer Consumer Care AG, Peter-Merian-Str. 84, 4002 Basel, Switzerland
*Corresponding Author : Ella Schaefer
Bayer Consumer Health Medical Affairs
Nutritionals, Peter-Merian-Str. 84
4002 Basel, Switzerland
Tel: +41582727522
E-mail: [email protected]
Received: January 22, 2016 Accepted: February 02, 2016 Published: February 10, 2016
Citation: Schaefer E, Bieri G, Sancak O, Barella L, Maggini S (2016) A Randomized, Placebo-Controlled Trial in Women of Childbearing Age to Assess the Effect of Folic Acid and Methyl-Tetrahydrofolate on Erythrocyte Folate Levels. Vitam Miner 5:134. doi:10.4172/2376-1318.1000134
Copyright: © 2016 Schaefer E, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
 

Abstract

Objective: To evaluate the efficacy of a multi-vitamin/mineral preparation (MMP) in achieving erythrocyte folate levels (Fol-E) considered preventive of neural tube defects (NTDs). Methods: In this single-center, double-blind, randomized, placebo (PBO)-controlled trial, healthy women of childbearing potential (WCBP) took either an oral MMP containing 400 μg folic acid and 451 μg L-5-methyltetrahydrofolate (MTHF) or PBO once daily for 16 weeks. Primary endpoints were achievement of Fol-E ≥ 906 nmol/L at Week 4 and maintenance of this level once achieved. Secondary efficacy variables were plasma concentrations of folate, homocysteine, and vitamins B2, B6, and B12 at Week 4, 8, 12, and 16. Results: Of the 40 women enrolled, 20 were randomized to each study arm. All but one PBO-subject completed the study as planned. Baseline characteristics in both groups were comparable with mean Fol-E around 500 nmol/L. In contrast to only one PBO-subject, all MMP subjects achieved and maintained the target Fol-E (MMP: 100% vs PBO: 5%, p<0.001), 14 (70%) MMP subjects already by Week 4 (means ± SD: 976 ± 186 vs 629 ± 215 nmol/L, p<0.001). In plasma, the only change under PBO was a 10% decrease of vitamin B12 whereas under MMP folate and vitamin B6 significantly increased and homocysteine significantly decreased. There was no serious and only one severe adverse event (AE); most common AEs were gastrointestinal with greater incidence in the MMP group (30% versus 5%). Conclusion: Supplementation with folic acid and MTHF at equimolar amounts was efficacious in replenishing Fol-E of WCBP within 4 weeks to levels considered protective of NTDs.

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