Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00889161 |
Date of registration:
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24/04/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Curcumin in Pediatric Inflammatory Bowel Disease
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Scientific title:
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Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study |
Date of first enrolment:
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May 2009 |
Target sample size:
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11 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00889161 |
Study type:
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Interventional |
Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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David Suskind, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Seattle Children's Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children and adolescents eight to eighteen years old
- Diagnosis of inflammatory bowel disease (IBD) made by a pediatric gastroenterologist
based upon history, physical examination, laboratory/radiological studies and
gastrointestinal histology
- Mild disease or in clinical remission based upon PUCAI or PCDAI score (score <34 on
the PUCAI or score <30 on the PCDAI)
- Parent/guardian and participant must be able to attend study visits at screening,
baseline, and weeks three, six, and nine
- Patient must be on a stable dose of IBD medications for at least 3 months
- Patient must be able to swallow study medication
Exclusion Criteria:
- Abnormal laboratory values as defined in the protocol
- History of increased gastrointestinal symptoms ("flare") in the last 3 months
- Current use (past use of these medications is not an exclusion) of medications such
as azathioprine, methotrexate or 6-mercaptopurine used to treat IBD
- Current use (past use of these medications is not an exclusion) of medications or
over-the-counter treatments including but not limited to aspirin, NSAID, botanical
treatments (ginger, feverfew, yellow clover, Salix species, Populus species, Betula
species, and Gaultheria species), essential fatty acids (flax oil and fish oil).
Allowed supplementation includes multivitamin, vitamin D & calcium, folate and
vitamin B12, and Iron.
- Other serious medical conditions such as neurological, liver, kidney, auto- immune or
systemic disease.
- History of gastrointestinal surgery or planned gastrointestinal surgery in the
future.
- Tobacco, alcohol, or illicit drug abuse
- Planned surgery during the potential study participation time
- Inability to swallow study medication
Age minimum:
8 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Inflammatory Bowel Disease
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Ulcerative Colitis
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Intervention(s)
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Drug: Curcumin
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Primary Outcome(s)
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To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease.
[Time Frame: 9 Weeks]
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Secondary ID(s)
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1UL1RR025014-01
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Curcumin-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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