- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00207532
Dosage Effects of Folic Acid on Blood Folates of Honduran Women
September 13, 2005 updated by: Centers for Disease Control and Prevention
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.
Study Overview
Study Type
Interventional
Enrollment
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Pedro Sula, Honduras
- PROTEXSA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
minimum employment in factory 6 mths
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Exclusion Criteria:
- pregnant
- currently consuming folic acid
- prior birth-defect affected pregnancy
- chronic disease
- currently taking folic acid antagonist
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gayle Milla, Project Healthy Children (Honduras)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
September 21, 2005
Last Update Submitted That Met QC Criteria
September 13, 2005
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCBDDD-4501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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