NCT00397917

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

5.5 years

First QC Date

November 8, 2006

Last Update Submit

March 30, 2017

Conditions

Cleft LipCleft Palate

Outcome Measures

Primary Outcomes (1)

  • Recurrence of cleft lip and palate

    3 months

Study Arms (2)

400 micrograms of folic acid

ACTIVE COMPARATOR

Blinded study with two arms one of 400ug in arm 1

Drug: Folic acid: 4 mg versus 0.4 mg per day

4mg of folic acid

ACTIVE COMPARATOR

Second arm is 4mg of folic acid in arm 2

Drug: Folic acid: 4 mg versus 0.4 mg per day

Interventions

Folic acid: 4 mg versus 0.4 mg per dayDRUG

Folic acid

400 micrograms of folic acid4mg of folic acid

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

  • Vila-Nova C, Wehby GL, Queiros FC, Chakraborty H, Felix TM, Goco N, Moore J, Gewehr EV, Lins L, Affonso CM, Murray JC. Periconceptional use of folic acid and risk of miscarriage - findings of the Oral Cleft Prevention Program in Brazil. J Perinat Med. 2013 Jul;41(4):461-6. doi: 10.1515/jpm-2012-0173.

    PMID: 23669628RESULT

  • Wehby GL, Goco N, Moretti-Ferreira D, Felix T, Richieri-Costa A, Padovani C, Queiros F, Guimaraes CV, Pereira R, Litavecz S, Hartwell T, Chakraborty H, Javois L, Murray JC. Oral cleft prevention program (OCPP). BMC Pediatr. 2012 Nov 26;12:184. doi: 10.1186/1471-2431-12-184.

    PMID: 23181832DERIVED

MeSH Terms

Conditions

Cleft LipCleft Palate

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesJaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal Abnormalities

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jeffrey Murray, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Random number assignments
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 10, 2006

Study Start

November 1, 2006

Primary Completion

May 1, 2012

Study Completion

July 1, 2013

Last Updated

March 31, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Individual level data will not be shared unless de-identified

Locations

US(1)