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Sponsors and Collaborators: |
Centers for Disease Control and Prevention Ministry of Health, Honduras Project Healthy Children |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00207532 |
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 |
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Spina Bifida and Anencephaly |
Drug: folic acid |
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 |
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
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Exclusion Criteria:
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 |
Folic Acid Neural Tube Defects Nervous System Malformations Spinal Dysraphism |
Spina bifida Neural tube defect, folate-sensitive Congenital Abnormalities Anencephaly |
Vitamin B Complex Hematinics Therapeutic Uses Growth Substances Vitamins Hematologic Agents |
Physiological Effects of Drugs Nervous System Diseases Micronutrients Monsters Pharmacologic Actions |