Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification

This study has been completed.
Sponsor:
Collaborators:
Peking University
Ministry of Science and Technology of the People´s Republic of China
University of Florida
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207558
First received: September 13, 2005
Last updated: July 12, 2006
Last verified: September 2005

September 13, 2005
July 12, 2006
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Complete list of historical versions of study NCT00207558 on ClinicalTrials.gov Archive Site
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Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification
Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification

The aim of this study is to examine whether the same total daily dosage of folic acid, when taken as a single daily dose or as multiple divided doses throughout the day, results in different blood folate and homocysteine levels at the conclusion of the study. Further, a comparison of blood folate and homocysteine levels among women taking daily low-dosage (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly high-dosage (4000mcg) folic acid will be conducted.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Neural Tube Defects - Spina Bifida and Anencephaly
Drug: folic acid
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Crider KS, Zhu JH, Hao L, Yang QH, Yang TP, Gindler J, Maneval DR, Quinlivan EP, Li Z, Bailey LB, Berry RJ. MTHFR 677C->T genotype is associated with folate and homocysteine concentrations in a large, population-based, double-blind trial of folic acid supplementation. Am J Clin Nutr. 2011 Jun;93(6):1365-72. doi: 10.3945/ajcn.110.004671. Epub 2011 Apr 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1100
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Inclusion Criteria:

-women who have delivered a baby two to four years ago, whose child is still alive, who are not breast-feeding, who are not pregnant or planning to become pregnant within the next 9 months following enrollment, who are using an IUD for contraception, and who have not taken vitamin supplements during the past 3 months

Exclusion Criteria:

-women who have not delivered a baby two to four years ago, whose child is deceased, who are breast-feeding, who are currently pregnant or planning to become pregnant within the next 9 months following enrollment, who are not using an IUD for contraception, and who have taken vitamin supplements during the past 3 months

Female
18 Years to 49 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00207558
CDC-NCBDDD-3970, U11/CCU015587-04-1, U11/CCU015586-05
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Centers for Disease Control and Prevention
  • Peking University
  • Ministry of Science and Technology of the People´s Republic of China
  • University of Florida
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Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP