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
About this trial
This is an interventional prevention trial for Neural Tube Defects
Eligibility Criteria
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
NCT ID
NCT00394862
First Posted
October 31, 2006
Last Updated
March 29, 2012
Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
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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