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Oral Cleft Prevention Trial in Brazil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00098319
Recruitment Status : Completed
First Posted : December 7, 2004
Last Update Posted : December 17, 2013
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
National Institute of Dental and Craniofacial Research (NIDCR)
Fogarty International Center of the National Institute of Health
National Center for Complementary and Integrative Health (NCCIH)
National Cancer Institute (NCI)
RTI International
University of Iowa
Hospital de Reabilitação de Anomalias Craniofaciais (HRAC) - Brazil
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health

Tracking Information
First Submitted Date  ICMJE December 6, 2004
First Posted Date  ICMJE December 7, 2004
Last Update Posted Date December 17, 2013
Study Start Date  ICMJE January 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2006)
Recurrence of nonsyndromic cleft lip with or without cleft palate (NSCL/P) in offspring of trial mothers
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Recurrence of nonsyndromic cleft lip with or without clef palate (NSCL/P) in offspring of trial mothers
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Recurrence of NSCL/P compared to a historical control group; Overall and high vs. 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Cleft Prevention Trial in Brazil
Official Title  ICMJE Oral Cleft Prevention Trial in Brazil
Brief Summary Cleft lip and palate are a significant component of morbid human birth defects in the developing world. By supplementing a high-risk group of women with folic acid (4.0 mg versus 0.4 mg) from preconception and continuing throughout the first 3 months of pregnancy in the state of Sao Paulo, Brazil, this study aims to reduce the recurrence of cleft lip and palate.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Cleft Lip
  • Cleft Palate
Intervention  ICMJE Drug: Folic acid (0.4mg vs. 4.0mg)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 23, 2005)
2200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00098319
Other Study ID Numbers  ICMJE GN 04 Aim III
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NICHD Global Network for Women's and Children's Health
Study Sponsor  ICMJE NICHD Global Network for Women's and Children's Health
Collaborators  ICMJE
  • Global Network for Women's and Children's Health Research
  • Bill and Melinda Gates Foundation
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • Fogarty International Center of the National Institute of Health
  • National Center for Complementary and Integrative Health (NCCIH)
  • National Cancer Institute (NCI)
  • RTI International
  • University of Iowa
  • Hospital de Reabilitação de Anomalias Craniofaciais (HRAC) - Brazil
Investigators  ICMJE
Principal Investigator: Jeff Murray, M.D. University of Iowa
PRS Account NICHD Global Network for Women's and Children's Health
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP