Dosage Effects of Folic Acid on Blood Folates of Honduran Women

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Honduras
Project Healthy Children
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00207532
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Dosage Effects of Folic Acid on Blood Folates of Honduran Women

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Honduras
PROTEXSA
San Pedro Sula, Honduras
Sponsors and Collaborators
Ministry of Health, Honduras
Project Healthy Children
Investigators
Principal Investigator: Gayle Milla Project Healthy Children (Honduras)
  More Information

No publications provided

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

Additional relevant MeSH terms:
Spinal Dysraphism
Anencephaly
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Abnormalities, Severe Teratoid
Folic Acid
Vitamin B Complex
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014