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Dosage Effects of Folic Acid on Blood Folates of Honduran Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207532
First Posted: September 21, 2005
Last Update Posted: September 21, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ministry of Health, Honduras
Project Healthy Children
Information provided by:
Centers for Disease Control and Prevention
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00207532     History of Changes
Other Study ID Numbers: CDC-NCBDDD-4501
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: September 21, 2005
Last Verified: September 2005

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
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs