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Dosage Effects of Folic Acid on Blood Folates of Honduran Women

Sponsor
Centers for Disease Control and Prevention (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00207532
Collaborator
Ministry of Health, Honduras (Other), Project Healthy Children (Other)
100
Enrollment
1
Location
3
Duration (Months)
33.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CDC staff at the National Center on Birth Defects and Developmental Disabilities have been working closely with a Honduras-based organization, Project Healthy Children (PNS) and the Ministry of Health, on a folic acid supplementation study among female maquila workers. Participants are divided into two groups. One group receives a 1.0 milligram pill daily while the other group receives a 5.0 milligram pill weekly. The aim of this study is to assess serum blood folate levels measured at baseline, midpoint, and endpoint of the study. Hypothesis: Folic acid (5mg)given once weekly is as effective as folic acid (1mg)given daily in raising blood folate levels.

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:
Dosage Effects of Folic Acid on Blood Folates of Honduran Women
Study Start Date :
Mar 1, 2005
Study Completion Date :
Jun 1, 2005

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:

    minimum employment in factory 6 mths

    -

    Exclusion Criteria:

    • pregnant

    • currently consuming folic acid

    • prior birth-defect affected pregnancy

    • chronic disease

    • currently taking folic acid antagonist

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PROTEXSA San Pedro Sula Honduras

    Sponsors and Collaborators

    • Centers for Disease Control and Prevention
    • Ministry of Health, Honduras
    • Project Healthy Children

    Investigators

    • Principal Investigator: Gayle Milla, Project Healthy Children (Honduras)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00207532
    Other Study ID Numbers:
    • CDC-NCBDDD-4501
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Sep 21, 2005
    Last Verified:
    Sep 1, 2005
    Additional relevant MeSH terms:
    Spinal Dysraphism
    Anencephaly
    Folic Acid

    Study Results

    No Results Posted as of Sep 21, 2005