Completed PHASE3 INTERVENTIONAL 2-arm NCT00397917

Oral Cleft Prevention Program

Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Interventions Folic acid: 4 mg versus 0.4 mg per day

Updated 6 times since 2017 Last updated: Mar 30, 2017 Started: Nov 30, 2006 Primary completion: May 31, 2012 Completion: Jul 31, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Cleft Lip and Cleft Palate and is currently completed. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) leads this study, which shows 6 recorded versions since 2006 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Apr 2017 — Jun 2018 [monthly]

Completed PHASE3

Status: Unknown Status → Completed

▶ Show 1 earlier version

Jan 2017 — Apr 2017 [monthly]

Unknown Status PHASE3

First recorded

Nov 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Dental and Craniofacial Research (NIDCR)
RTI International
University of Iowa
University of Sao Paulo

Data source: University of Iowa

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Iowa City, United States