NCT00207532

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

September 21, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Spina Bifida and Anencephaly

Interventions

folic acidDRUG

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • minimum employment in factory 6 mths

You may not qualify if:

  • pregnant
  • currently consuming folic acid
  • prior birth-defect affected pregnancy
  • chronic disease
  • currently taking folic acid antagonist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PROTEXSA

San Pedro Sula, Honduras

Location

MeSH Terms

Conditions

Neural tube defects X-linked

Interventions

Folic Acid

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gayle Milla

    Project Healthy Children (Honduras)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 1, 2005

Study Completion

June 1, 2005

Last Updated

September 21, 2005

Record last verified: 2005-09

Locations

HO(1)