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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

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

NCT ID

NCT00207532

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

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

Eligibility Criteria

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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