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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

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ClinicalTrials.gov Identifier: NCT00207558
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 13, 2006
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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Neural Tube Defects - Spina Bifida and Anencephaly Drug: folic acid Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00207558     History of Changes
Other Study ID Numbers: CDC-NCBDDD-3970
U11/CCU015587-04-1
U11/CCU015586-05
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: July 13, 2006
Last Verified: September 2005

Additional relevant MeSH terms:
Spinal Dysraphism
Neural Tube Defects
Anencephaly
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Abnormalities, Severe Teratoid
 Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs