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Dosage Effects of Folic Acid on Blood Folates of Honduran Women

Primary Purpose

Spina Bifida and Anencephaly

Status
Completed
Phase
Not Applicable
Locations
Honduras
Study Type
Interventional
Intervention
folic acid
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spina Bifida and Anencephaly

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • PROTEXSA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
Ministry of Health, Honduras, Project Healthy Children
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1. Study Identification

Unique Protocol Identification Number
NCT00207532
Brief Title
Dosage Effects of Folic Acid on Blood Folates of Honduran Women
Official Title
Dosage Effects of Folic Acid on Blood Folates of Honduran Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Ministry of Health, Honduras, Project Healthy Children

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spina Bifida and Anencephaly

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
folic acid

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gayle Milla
Organizational Affiliation
Project Healthy Children (Honduras)
Official's Role
Principal Investigator
Facility Information:
Facility Name
PROTEXSA
City
San Pedro Sula
Country
Honduras

12. IPD Sharing Statement

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Dosage Effects of Folic Acid on Blood Folates of Honduran Women

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