Dosage Effects of Folic Acid on Blood Folates of Honduran Women

This study has been completed.

Sponsors and Collaborators:	Centers for Disease Control and Prevention Ministry of Health, Honduras Project Healthy Children
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00207532

Purpose

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	Intervention
Spina Bifida and Anencephaly	Drug: folic acid

MedlinePlus related topics: Spina Bifida

Drug Information available for: Folic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacokinetics Study
Official Title:	Dosage Effects of Folic Acid on Blood Folates of Honduran Women

Further study details as provided by Centers for Disease Control and Prevention:

Estimated Enrollment:	100
Study Start Date:	March 2005
Estimated Study Completion Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 49 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207532

Locations

Honduras
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)

More Information

Study ID Numbers:	CDC-NCBDDD-4501
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00207532
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Folic Acid
Neural Tube Defects
Nervous System Malformations
Spinal Dysraphism

Spina bifida
Neural tube defect, folate-sensitive
Congenital Abnormalities
Anencephaly

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins
Hematologic Agents

Physiological Effects of Drugs
Nervous System Diseases
Micronutrients
Monsters
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009