MedTrace Logo

Oral Cleft Prevention Program

NCT00397917 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2017-03-31

No results posted yet for this study

Summary

The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception and during the first three months of pregnancy decreases the risk of having a child with cleft lip and palate compared to 0.4 mg folic acid for women who have an oral cleft or have had previously child with an oral cleft.

Conditions

  • Cleft Lip
  • Cleft Palate

Interventions

DRUG

Folic acid: 4 mg versus 0.4 mg per day

Folic acid

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • RTI International

    collaborator OTHER

  • University of Sao Paulo

    collaborator OTHER

  • University of Iowa

    lead OTHER

Principal Investigators

  • Jeffrey Murray, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2012-05-31
Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00397917 on ClinicalTrials.gov