Cleft LipPhase 3NCT00098319
Oral Cleft Prevention Trial in Brazil
A Phase 3 study testing Folic acid (0.4mg vs. 4.0mg) in people with Cleft Lip and Cleft Palate, run by NICHD Global Network for Women's and Children's Health at 3 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip, Cleft Palate
- What is being tested?
- Folic acid (0.4mg vs. 4.0mg)
- How many people
- 2,200 participants
- Where
- 3 sitesBrazil
- Study dates
- Jan 2004to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Hospital de Reabilitação de Anomalias Craniofaciais (HRAC)
Bauru, São Paulo
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre
Hospital Santo Antonio-Centrinho: Obras Sociais Irma Dulce
Salvador
About this study
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.
Read the 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.
- Conditions
- Cleft Lip, Cleft Palate
- Being tested
- Folic acid (0.4mg vs. 4.0mg)
- Keywords
- Cleft palate, Cleft lip, Folic acid, Global Network, Maternal and child health, International, Women's health, Brazil, Brasil, Latin America, ECLAMC, Congenital defects, Pregnancy
- Medical subject headings
- Cleft Lip, Cleft Palate, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acid (0.4mg vs. 4.0mg)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of nonsyndromic cleft lip with or without cleft palate (NSCL/P) in offspring of trial mothers
Secondary outcomes (9)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2004 (estimated)
- Study startJan 2004
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- 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
- Responsible party
- Sponsor
- Investigators
- Jeff Murray, M.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098319
- Sponsor's protocol ID
- GN 04 Aim III
- Status last verified
- Dec 2013
- First submitted
- 6 Dec 2004
- Last updated
- 17 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Cleft Prevention Trial in Brazil
- ClinicalTrials.gov ID
- NCT00098319
- Acronym / sponsor ID
- GN 04 Aim III
- Conditions
- Cleft Lip, Cleft Palate
- Keywords
- Cleft palate, Cleft lip, Folic acid, Global Network, Maternal and child health, International, Women's health, Brazil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- 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
- Study start
- Jan 2004
- Study completion
- Apr 2007 (actual)
- First posted
- 7 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic acid (0.4mg vs. 4.0mg) | Drug | – |
Primary outcome
Recurrence of nonsyndromic cleft lip with or without cleft palate (NSCL/P) in offspring of trial mothers
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
- Global Network for Women's and Children's Health ResearchLink provided by the sponsor.
- RTI InternationalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Murray, M.D. principal investigator
University of Iowa
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Folic acid (0.4mg vs. 4.0mg) in people with Cleft Lip and Cleft Palate, run by NICHD Global Network for Women's and Children's Health at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of nonsyndromic cleft lip with or without cleft palate (NSCL/P) in offspring of trial mothers. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.