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Sponsors and Collaborators: |
National Institute of Dental and Craniofacial Research (NIDCR) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) University of Iowa RTI International University of Sao Paulo |
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Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
ClinicalTrials.gov Identifier: | NCT00397917 |
The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception and during the first three months of pregnancy decreases the risk of having a child with cleft lip and palate compared to 0.4 mg folic acid for women who have an oral cleft or have had previously child with an oral cleft.
Condition | Intervention | Phase |
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Cleft Lip Cleft Palate |
Drug: Folic acid: 4 mg versus 0.4 mg per day |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Efficacy Study |
Official Title: | Oral Cleft Prevention Program |
Estimated Enrollment: | 6000 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Cleft lip and palate is a common and burdensome birth defect that has large health ramifications and requires surgical, speech, behavioral, dental, and medical interventions. There is some evidence suggesting that taking folic acid particularly at large doses during preconception and first trimester of pregnancy may decrease the risk of oral cleft recurrence, which is the risk of having a child with an oral cleft for women who have an oral cleft or who have had a child with a cleft. However this evidence is based on study designs that are incapable of contributing the preventive effects to folic acid with adequate confidence, and the real effect of folic acid on cleft recurrence prevention remains to be identified. Taking 4 mg of folic acid per day at preconception and first trimester of pregnancy has also been shown to prevent the recurrence of neural tube defects by up to 70%, providing further support to evaluate this intervention for oral cleft recurrence.
This study evaluates the effects of supplementation with 4 versus 0.4 mg of folic acid per day at preconception and during the first three months of pregnancy on recurrence of cleft lip and palate. Up to 6000 women will be randomly assigned to 4 versus 0.4 mg groups. The primary aim is to compare the recurrence rates in the offspring of trial mothers in the two groups. Secondary aims are to compare the two groups on several outcomes including miscarriage, twinning, pre-eclampsia, serum and red cell folate levels, severity of oral clefts and occurrence of other birth defects in the offspring of trial mothers, and birth weight and gestational age of trial babies, and to compare the recurrence in the two groups to that in historic controls.
Ages Eligible for Study: | 16 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeff Murray, MD | 319-335-6897 | jeff-murray@uiowa.edu |
Contact: Danilo Moretti-Ferreira, MD | 55-142355-8183 | danilo@ibb.unesp.br |
United States, Iowa | |
University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Jeff C Murray, MD 319-335-6897 jeff-murray@uiowa.edu | |
Principal Investigator: Jeff Murray, MD |
Principal Investigator: | Jeffrey Murray, MD | University of Iowa |
Responsible Party: | University of Iowa ( Jeff Murray, MD ) |
Study ID Numbers: | NIDCR-17958 |
Study First Received: | November 8, 2006 |
Last Updated: | July 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00397917 |
Health Authority: | United States: Federal Government |
Folic Acid Mouth Diseases Cleft Palate Musculoskeletal Diseases Cleft Lip |
Craniofacial Abnormalities Maxillofacial Abnormalities Stomatognathic Diseases Congenital Abnormalities Musculoskeletal Abnormalities |
Vitamin B Complex Hematinics Growth Substances Physiological Effects of Drugs Hematologic Agents Jaw Diseases Stomatognathic System Abnormalities |
Lip Diseases Pharmacologic Actions Mouth Abnormalities Therapeutic Uses Vitamins Jaw Abnormalities Micronutrients |