NCT00397917

Oral Cleft Prevention Program

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,000 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: Female
• Age: 16 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cleft Lip
• Cleft Palate

Interventions

Type	Name	Description
DRUG	Folic acid: 4 mg versus 0.4 mg per day	Folic acid

Timeline

• Start date: 2006-11-01
• Primary completion: 2012-05-01
• Completion: 2013-07-01
• First posted: 2006-11-10
• Last updated: 2017-03-31

Locations

1 site across 1 country: United States