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Oral Cleft Prevention Program

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ClinicalTrials.gov Identifier: NCT00397917
Recruitment Status : Completed
First Posted : November 10, 2006
Last Update Posted : March 31, 2017
Sponsor:
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
RTI International
University of Sao Paulo
Information provided by (Responsible Party):
Jeff Murray, University of Iowa

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 0.4 mg folic acid for women who have an oral cleft or have had previously child with an oral cleft.

Condition or disease Intervention/treatment Phase
Cleft Lip Cleft Palate Drug: Folic acid: 4 mg versus 0.4 mg per day Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Random number assignments
Primary Purpose: Prevention
Official Title: Oral Cleft Prevention Program
Study Start Date : November 2006
Actual Primary Completion Date : May 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 400 micrograms of folic acid
Blinded study with two arms one of 400ug in arm 1
Drug: Folic acid: 4 mg versus 0.4 mg per day
Folic acid

Active Comparator: 4mg of folic acid
Second arm is 4mg of folic acid in arm 2
Drug: Folic acid: 4 mg versus 0.4 mg per day
Folic acid




Primary Outcome Measures :
  1. Recurrence of cleft lip and palate [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with cleft lip with/out palate (CLP), 16 to 45 years of age registered at the study clinics in Brazil or Women (16 to 45 years of age) with at least one natural child of any age with CLP registered at the study clinics.
  • Women must reside in the catchment area of the study, which includes the states where the study clinics are located and surrounding states.

Exclusion Criteria:

  • Consanguineous couples (up to third degree, i.e. first cousins or closer).
  • Pregnany at the time of recruitment. Women will be recontacted later at an appropriate time for participation in the study.
  • Couples either one of which have been sterilized.
  • Taking any form of seizure medication.
  • Planning to move outside of the study catchment area within the next year.
  • B12 deficiency (<174 pg/mL or 129.15 pmol/L).
  • Being allergic to folic acid.

Information from the National Library of Medicine

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): NCT00397917


Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
National Institute of Dental and Craniofacial Research (NIDCR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
RTI International
University of Sao Paulo
Investigators
Principal Investigator: Jeffrey Murray, MD University of Iowa

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff Murray, Professor of Pediatrics, University of Iowa
ClinicalTrials.gov Identifier: NCT00397917     History of Changes
Other Study ID Numbers: NIDCR-17958
U01DE017958 ( U.S. NIH Grant/Contract )
First Posted: November 10, 2006    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual level data will not be shared unless de-identified

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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