Dosage Effects of Folic Acid on Blood Folates of Honduran Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Spina Bifida and Anencephaly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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folic acid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Gayle Milla

Role: PRINCIPAL_INVESTIGATOR

Project Healthy Children (Honduras)

Locations

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PROTEXSA

San Pedro Sula, , Honduras

Site Status

Countries

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Honduras

Other Identifiers

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CDC-NCBDDD-4501

Identifier Type: -

Identifier Source: org_study_id