Dosage Effects of Folic Acid on Blood Folates of Honduran Women

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

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

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

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 identifier: NCT00207532

San Pedro Sula, Honduras
Sponsors and Collaborators
Centers for Disease Control and Prevention
Ministry of Health, Honduras
Project Healthy Children
Principal Investigator: Gayle Milla Project Healthy Children (Honduras)
  More Information

No publications provided 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
Abnormalities, Severe Teratoid
Congenital Abnormalities
Nervous System Diseases
Nervous System Malformations
Neural Tube Defects
Folic Acid
Vitamin B Complex
Growth Substances
Hematologic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins processed this record on October 02, 2015