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NCT01926730 · ClinicalTrials.gov registry record · NA
Food and Crohn's Exacerbation Study (FACES)
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 216
- Enrollment target
NCT01926730: Completed NA study, sponsored by University of Pennsylvania.
NCT01926730 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 216 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01926730, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 216 participants
- Enrollment target
Study Summary
The proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. Disease activity will be assessed with the abbreviated Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the study diets will be assessed with food frequency questionnaires (FFQs) administered after 20 weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to relapse using Cox regression for patients in the two study arms. In the exploratory aim, we will compare outcomes among patients in the highest tertile for other food items and nutrients to those in the lowest tertile based on self-reported usual dietary patterns at baseline. Thus, the study population will be analyzed both as a randomized controlled trial and as a prospective cohort study.
Interventions
- OTHER Restriction diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01926730
The ClinicalTrials.gov registry entry for NCT01926730 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Restriction diet is the first listed.
NCT01926730 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01926730 about?
NCT01926730 is a clinical study titled "Food and Crohn's Exacerbation Study (FACES)". The proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding...
What is the current status of trial NCT01926730?
This trial is currently completed. It is a NA study. The enrollment target is 216 participants. The study started on 2013-11. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01926730?
The interventions under investigation include: Restriction diet (OTHER).
Who is sponsoring clinical trial NCT01926730?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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