Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease (DINE-CD)
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ClinicalTrials.gov Identifier: NCT03058679 |
Recruitment Status :
Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : May 12, 2020
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Sponsor:
University of Pennsylvania
Collaborators:
Patient-Centered Outcomes Research Institute
Crohn's and Colitis Foundation
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
University of Pennsylvania
Tracking Information | |||||
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First Submitted Date ICMJE | February 16, 2017 | ||||
First Posted Date ICMJE | February 23, 2017 | ||||
Last Update Posted Date | May 12, 2020 | ||||
Actual Study Start Date ICMJE | September 29, 2017 | ||||
Actual Primary Completion Date | March 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease | ||||
Official Title ICMJE | Open Label, Randomized, Multicenter, Comparative Effectiveness Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission in Patients With Crohn's Disease | ||||
Brief Summary | This protocol is designed to compare the effectiveness of two dietary interventions for patients with Crohn's disease (CD): the Specific Carbohydrate Diet (SCD) and a Mediterranean style diet (MSD) that has been demonstrated to have numerous other health benefits. The two diets will be compared in terms of their ability to resolve both the symptoms and bowel inflammation that characterize this debilitating disease. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Crohn Disease | ||||
Intervention ICMJE | Other: Diet
food for the diet will be provided to the participants for 6 weeks
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
194 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 2021 | ||||
Actual Primary Completion Date | March 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03058679 | ||||
Other Study ID Numbers ICMJE | 825907 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Pennsylvania | ||||
Study Sponsor ICMJE | University of Pennsylvania | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Pennsylvania | ||||
Verification Date | May 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |