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NCT00397917 · ClinicalTrials.gov registry record · Phase 3
Oral Cleft Prevention Program
A Phase 3 study, sponsored by University of Iowa.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,000
- Enrollment target
NCT00397917: Completed Phase 3 study, sponsored by University of Iowa.
NCT00397917 is a Phase 3 study that has completed, run by University of Iowa. The registered enrollment target is 4,000 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (418% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00397917, a Phase 3 study, has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,000 participants
- Enrollment target
Study 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.
Interventions
- DRUG Folic acid: 4 mg versus 0.4 mg per day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,000 participants |
| Start Date | 2006-11 |
| Est. Completion | 2013-07 |
| Phase | Phase 3 |
What the finished NCT00397917 record still lists
NCT00397917 is an interventional study that assigns participants to a tested intervention. Its 4,000 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (418% higher).
The record links to 0 conditions, and to 1 intervention - of which Folic acid: 4 mg versus 0.4 mg per day is the first listed.
NCT00397917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00397917 about?
NCT00397917 is a clinical study titled "Oral Cleft Prevention Program". 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 a...
What is the current status of trial NCT00397917?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,000 participants. The study started on 2006-11. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00397917?
The interventions under investigation include: Folic acid: 4 mg versus 0.4 mg per day (DRUG).
Who is sponsoring clinical trial NCT00397917?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00397917's enrollment target sits among peer trials
4,000 61st of 2000 higher than 1,938 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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