Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397917
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2006-11-08
Brief Title:
Oral Cleft Prevention Program
Sponsor:
University of Iowa
Organization:
University of Iowa
Study Overview
Official Title:
Oral Cleft Prevention Program
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 04 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 04 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 04 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
This study evaluates the effects of supplementation with 4 versus 04 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 04 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DE017958 | NIH | None | httpsreporternihgovquickSearchU01DE017958 |