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| Sponsors and Collaborators: |
National Institute of Child Health and Human Development (NICHD) 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 |
| Information provided by: | National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00098319 |
Purpose
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.
| Condition | Intervention | Phase |
|
Cleft Lip Cleft Palate |
Drug: Folic acid (0.4mg vs. 4.0mg) |
Phase III |
| Genetics Home Reference related topics: | Baller-Gerold syndrome Crouzon syndrome |
| MedlinePlus related topics: | Cleft Lip and Palate |
| ChemIDplus related topics: | Folic acid |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | Oral Cleft Prevention Trial in Brazil |
| Estimated Enrollment: | 2200 |
| Study Start Date: | January 2004 |
| Study Completion Date: | April 2007 |
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.
Eligibility
| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Brazil | |||||
| Hospital de Clinicas de Porto Alegre (HCPA) | |||||
| Porto Alegre, Brazil | |||||
| Hospital Santo Antonio-Centrinho: Obras Sociais Irma Dulce | |||||
| Salvador, Brazil | |||||
| Brazil, Sao Paulo | |||||
| Hospital de Reabilitação de Anomalias Craniofaciais (HRAC) | |||||
| Bauru, Sao Paulo, Brazil | |||||
| National Institute of Child Health and Human Development (NICHD) |
| 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 |
| Principal Investigator: | Jeff Murray, M.D. | University of Iowa |
More Information
Global Network for Women's and Children's Health Research 
  |
RTI International 
  |
| Study ID Numbers: | GN 04 Aim III |
| First Received: | December 6, 2004 |
| Last Updated: | August 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00098319 |
| Health Authority: | United States: Federal Government |
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