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

History of Changes

Purpose

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.

Condition	Intervention
Neural Tube Defects - Spina Bifida and Anencephaly	Drug: folic acid


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification

Resource links provided by NLM:

Genetics Home Reference related topics: anencephaly spina bifida

MedlinePlus related topics: B Vitamins Neural Tube Defects

Drug Information available for: Folic acid Vitamin B Complex

Genetic and Rare Diseases Information Center resources: Anencephaly Spina Bifida

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:


Estimated Enrollment:	1100

Eligibility


Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207558

Locations


China, Hebei
Townships
Xianghe County, Hebei, China

Sponsors and Collaborators

Centers for Disease Control and Prevention

Peking University

Ministry of Science and Technology of the People´s Republic of China

University of Florida

More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00207558 History of Changes
Other Study ID Numbers:	CDC-NCBDDD-3970, U11/CCU015587-04-1, U11/CCU015586-05
Study First Received:	September 13, 2005
Last Updated:	July 12, 2006
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:


Neural Tube Defects Congenital Abnormalities Nervous System Diseases Nervous System Malformations Folic Acid Vitamin B Complex Growth Substances	Hematinics Hematologic Agents Micronutrients Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Vitamins

ClinicalTrials.gov processed this record on February 27, 2015

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