ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Oral Cleft Prevention Trial in Brazil

This study has been completed.
Study NCT00098319.   Last updated on August 13, 2007.   Information provided by National Institute of Child Health and Human Development (NICHD)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Oral Cleft Prevention Trial in Brazil
Official Title  Oral Cleft Prevention Trial in Brazil
Brief Summary

Cleft lip and palate are a significant component of morbid human birth defects in the developing world. By supplementing a high-risk group of women with folic acid (4.0 mg versus 0.4 mg) from preconception and continuing throughout the first 3 months of pregnancy in the state of Sao Paulo, Brazil, this study aims to reduce the recurrence of cleft lip and palate.

Detailed Description

Craniofacial anomalies and cleft lip with or without cleft palate (CL/P) are a model for the impact of birth defects on fetal and neonatal health directly and maternal health indirectly. Craniofacial anomalies comprise a significant component of morbid human birth defects. The primary hypothesis is that folic acid supplementation of 4mg/day at preconception and during the first three months of pregnancy will decrease the recurrence of nonsyndromic cleft lip with or without clef palate (NSCL/P) in a high-risk group of women when compared to women taking 0.4 mg per day of folic acid. The total sample will include 2,000 women (that either have NSCL/P or that have at least one child with NSCL/P) randomly assigned to the 4 mg versus the 0.4 mg folic acid study groups. The study will also compare the recurrence rates of NSCL/P in the total sample of subjects as well as the two study groups (4mg, 0.4 mg) to that of a historical control group.

The primary outcome assessed is the rate of recurrences of NSCL/P in offspring of the trial mothers in each of the two study groups. Secondary outcomes include recurrence of NSCL/P compared to a historical control group; serum and red cell folate levels; severity of NSCL/P in offspring of trial mothers; twinning rate; miscarriage rate; preeclampsia; rates of other birth defects; birth weight; and gestational age. The sample size was based on historic tables of birth rates and the rates of cleft occurrences. The study hypothesizes that a total of 2000 subjects will be enrolled during a 2.5 year period; a dropout rate of 10%; birth rate for group A (women with NSCL/P) of 10% and a rate of 12% for group B (women with at least one child with NSCL/P); risk of cleft for group A is 7% and for group B is 4%; one-sided test with continuity correction.

Study Phase Phase III
Study Type  Interventional
Study Design  Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Recurrence of nonsyndromic cleft lip with or without cleft palate (NSCL/P) in offspring of trial mothers
Secondary Outcome Measure  Recurrence of NSCL/P compared to a historical control group; Overall and high versus low dose
Serum and red cell folate levels
Severity of NSCL/P in offspring of trial mothers
Twinning rate
Miscarriage rate
Preeclampsia
Rates of other birth defects
Birth weight
Gestational age
Condition  Cleft Lip
Cleft Palate
Intervention  Drug: Folic acid (0.4mg vs. 4.0mg)
MEDLINE PMIDs
Links Global Network for Women's and Children's Health Research This link exits the ClinicalTrials.gov site
RTI International This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  2200
Start Date  January 2004
Completion Date April 2007
Eligibility Criteria 

Inclusion Criteria:

  • All women must reside in the state where the clinic is located.
  • Women with NSCL/P who attend the craniofacial clinics, who are 16 to 45 years of age (after age 45 fecundity decreases substantially)who attend the craniofacial clinic for their care.
  • Women (ages 16 to 45 years of age) who have at least one natural child of any age with NSCL/P who receives care at the participating craniofacial clinics.

Exclusion Criteria:

  • Cases resulting from consanguineous couples (first, second, and third degree, i.e., first cousins or closer).
  • Couples where at least one of the two is definitely sterilized.
  • Women on anti-epileptic drugs.
  • Women who are pregnant.
  • Women who are planning to move outside of the state where the clinic is located within the next year.
  • Women who are planning to move outside of Sao Paulo state within the next year.
  • Women who have B12 deficiency (B12 level is below 174 pg/ml or 134.328 pmol/L).
  • Women who have an allergy to folic acid.
Gender Female
Ages 16 Years to 45 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  Brazil
Administrative Information Fields
NCT ID  NCT00098319
Organization ID GN 04 Aim III
Secondary IDs ††
Study Sponsor  National Institute of Child Health and Human Development (NICHD)
Collaborators †† Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
National Institute of Dental and Craniofacial Research (NIDCR)
John E. Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
National Cancer Institute (NCI)
RTI International
University of Iowa
Hospital de Reabilitação de Anomalias Craniofaciais (HRAC) - Brazil
Investigators 
Principal Investigator:     Jeff Murray, M.D.     University of Iowa    
Information Provided By National Institute of Child Health and Human Development (NICHD)
Verification Date August 2007
First Received Date  December 6, 2004
Last Updated Date August 13, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers