Cleft Palate Clinical Trial
Official title:
Oral Cleft Prevention Trial in Brazil
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.
Status | Completed |
Enrollment | 2200 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Reabilitação de Anomalias Craniofaciais (HRAC) | Bauru | Sao Paulo |
Brazil | Hospital de Clinicas de Porto Alegre (HCPA) | Porto Alegre | |
Brazil | Hospital Santo Antonio-Centrinho: Obras Sociais Irma Dulce | Salvador |
Lead Sponsor | Collaborator |
---|---|
NICHD Global Network for Women's and Children's Health | Bill and Melinda Gates Foundation, Global Network for Women's and Children's Health Research, Hospital de Reabilitação de Anomalias Craniofaciais (HRAC) - Brazil, John E. Fogarty International Center (FIC), National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), RTI International, University of Iowa |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence of nonsyndromic cleft lip with or without cleft palate (NSCL/P) in offspring of trial mothers | |||
Secondary | Recurrence of NSCL/P compared to a historical control group; Overall and high versus low dose | |||
Secondary | Serum and red cell folate levels | |||
Secondary | Severity of NSCL/P in offspring of trial mothers | |||
Secondary | Twinning rate | |||
Secondary | Miscarriage rate | |||
Secondary | Preeclampsia | |||
Secondary | Rates of other birth defects | |||
Secondary | Birth weight | |||
Secondary | Gestational age |
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