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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

Sponsor
Centers for Disease Control and Prevention (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00207558
Collaborator
Peking University (Other), Ministry of Science and Technology of the People´s Republic of China (Other), University of Florida (Other)
1,100
Enrollment
1
Location

Study Details

Study Description

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
  • Drug: folic acid
 N/A

Study Design

Study Type:
Interventional
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00207558
    Other Study ID Numbers:
    • CDC-NCBDDD-3970
    • U11/CCU015587-04-1
    • U11/CCU015586-05
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Jul 13, 2006
    Last Verified:
    Sep 1, 2005
    Additional relevant MeSH terms:
    Spinal Dysraphism
    Neural Tube Defects
    Anencephaly
    Folic Acid

    Study Results

    No Results Posted as of Jul 13, 2006