Spina Bifida and Anencephaly Clinical Trial
Official title:
Dosage Effects of Folic Acid on Blood Folates of Honduran Women
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | June 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 49 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Honduras | PROTEXSA | San Pedro Sula |
| Lead Sponsor | Collaborator |
|---|---|
| Centers for Disease Control and Prevention | Ministry of Health, Honduras, Project Healthy Children |
Honduras,