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.

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
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00207558

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

MedlinePlus related topics: Neural Tube Defects Spina Bifida

Drug Information available for: Folic acid Homocysteine

U.S. FDA Resources

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

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

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

Locations

China, Hebei Province
Townships
Xianghe County, Hebei Province, 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

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

Study placed in the following topic categories:

Folic Acid
Neural Tube Defects
Nervous System Malformations
Spinal Dysraphism

Spina bifida
Neural tube defect, folate-sensitive
Congenital Abnormalities
Anencephaly

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins
Hematologic Agents

Physiological Effects of Drugs
Nervous System Diseases
Micronutrients
Monsters
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009