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 Intervention Model: Parallel Assignment Masking: Double 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
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| Ages Eligible for Study: | 16 Years to 45 Years (Child, Adult) |
| Sexes 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 Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| First Submitted: | December 6, 2004 |
| First Posted: | December 7, 2004 |
| Last Update Posted: | December 17, 2013 |
| Last Verified: | December 2013 |
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 |