Neural Tube Defects - Spina Bifida and Anencephaly Clinical Trial
Official title:
Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification
| NCT number | NCT00207558 |
| Other study ID # | CDC-NCBDDD-3970 |
| Secondary ID | U11/CCU015587-04 |
| Status | Completed |
| Phase | N/A |
| First received | September 13, 2005 |
| Last updated | July 12, 2006 |
The aim of this study is to examine whether the same total daily dosage of folic acid, when taken as a single daily dose or as multiple divided doses throughout the day, results in different blood folate and homocysteine levels at the conclusion of the study. Further, a comparison of blood folate and homocysteine levels among women taking daily low-dosage (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly high-dosage (4000mcg) folic acid will be conducted.
| Status | Completed |
| Enrollment | 1100 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 49 Years |
| Eligibility |
Inclusion Criteria: -women who have delivered a baby two to four years ago, whose child is still alive, who are not breast-feeding, who are not pregnant or planning to become pregnant within the next 9 months following enrollment, who are using an IUD for contraception, and who have not taken vitamin supplements during the past 3 months Exclusion Criteria: -women who have not delivered a baby two to four years ago, whose child is deceased, who are breast-feeding, who are currently pregnant or planning to become pregnant within the next 9 months following enrollment, who are not using an IUD for contraception, and who have taken vitamin supplements during the past 3 months |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| China | Townships | Xianghe County | Hebei |
| Lead Sponsor | Collaborator |
|---|---|
| Centers for Disease Control and Prevention | Ministry of Science and Technology of the People´s Republic of China, Peking University, University of Florida |
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