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Efficacy of Weekly Versus Daily Folic Acid Supplementation

Primary Purpose

Neural Tube Defects

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
multivitamin
Sponsored by
Emory University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neural Tube Defects

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • female
  • aged 15-49

Exclusion Criteria:

  • pregnant
  • lactating less than 3 months
  • severely anemic

Sites / Locations

    Outcomes

    Primary Outcome Measures

    serum folate level
    red blood cell folate

    Secondary Outcome Measures

    homocysteine
    ferritin
    serum zinc
    serum B12
    blood pressure
    depression

    Full Information

    First Posted
    October 31, 2006
    Last Updated
    March 29, 2012
    Sponsor
    Emory University
    Collaborators
    Centers for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00394862
    Brief Title
    Efficacy of Weekly Versus Daily Folic Acid Supplementation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    July 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Emory University
    Collaborators
    Centers for Disease Control and Prevention

    4. Oversight

    5. Study Description

    Brief Summary
    Investigate the efficacy of weekly versus daily of folic acid supplementation on improving folate, vitamin B12,
    Detailed Description
    460 women of a rural community in the western highlands of Guatemala were recruited for participation in the double-blinded study led by Emory University and the Institute of Nutrition of Central America and Panama (INCAP). The women were randomly assigned one of 4 vitamin treatments containing different levels of folic acid, Vitamin B12, iron and zinc. The treatments were as follows: weekly dose of folic acid at 5000ug, iron at 120 mg, zinc at 30mg, and B12 at 16.8 ug; weekly dose of folic acid at 2800ug, iron at 120mg, zinc at 0mg and B12 at 16.8ug; daily dose of folic acid at 400ug, iron at 60mg, zinc at 15mg, B12 at 2.4ug; and daily dose of folic acid at 200ug, iron at 50mg, zinc at 0mg, and B12 at 2.4ug. The women, aged 15-49, received the vitamins daily for 3 months. Anthropometric data and blood samples were taken at baseline and post-supplementation. The participants also completed a series of dietary interviews at baseline and post-intervention. No pregnant or lactating mothers were admitted into the study, nor severely anemic females. Blood samples were sent to the National Laboratory in Cuernavaca, Mexico, for analysis of serum folate levels.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neural Tube Defects

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    460 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    multivitamin
    Primary Outcome Measure Information:
    Title
    serum folate level
    Title
    red blood cell folate
    Secondary Outcome Measure Information:
    Title
    homocysteine
    Title
    ferritin
    Title
    serum zinc
    Title
    serum B12
    Title
    blood pressure
    Title
    depression

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: female aged 15-49 Exclusion Criteria: pregnant lactating less than 3 months severely anemic
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Reynaldo Martorell, PHD, MPH
    Organizational Affiliation
    Emory University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Weekly Versus Daily Folic Acid Supplementation

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