Oral Cleft Prevention Trial in Brazil
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Cleft Lip Cleft Palate |
Drug: Folic acid (0.4mg vs. 4.0mg) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Oral Cleft Prevention Trial in Brazil |
- Recurrence of nonsyndromic cleft lip with or without cleft palate (NSCL/P) in offspring of trial mothers
- 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
| 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 (Child, Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00098319
| 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, Brazil | |
| Principal Investigator: | Jeff Murray, M.D. | University of Iowa |
More Information
Additional Information:
| Responsible Party: | NICHD Global Network for Women's and Children's Health |
| ClinicalTrials.gov Identifier: | NCT00098319 History of Changes |
| Other Study ID Numbers: | GN 04 Aim III |
| Study First Received: | December 6, 2004 |
| Last Updated: | December 16, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by NICHD Global Network for Women's and Children's Health:
|
Maternal and child health Women's health Cleft palate Cleft lip Folic acid Global Network International |
Brazil Brasil Latin America ECLAMC Congenital defects Pregnancy |
Additional relevant MeSH terms:
|
Cleft Lip Cleft Palate Lip Diseases Mouth Diseases Stomatognathic Diseases Mouth Abnormalities Stomatognathic System Abnormalities Congenital Abnormalities Jaw Abnormalities Jaw Diseases Musculoskeletal Diseases |
Maxillofacial Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities Folic Acid Vitamin B Complex Hematinics Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016