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Trial record 3 of 5 for:    "Anencephaly"
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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:

U.S. FDA Resources

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

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

ClinicalTrials.gov processed this record on May 16, 2013