Curcumin in Pediatric Inflammatory Bowel Disease
This study has been completed.
Sponsor:
Seattle Children's Hospital
Information provided by:
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00889161
First received: April 24, 2009
Last updated: June 16, 2010
Last verified: June 2010
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Purpose
This is a single center, open label forced dose titration study designed to determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease (IBD). This study will provide initial tolerability and safety data in pediatric patients with IBD. Twenty patients with IBD in remission or with mild disease (score <34 on PUCAI or score <30 on the PCDAI) on sulfasalazine or mesalamine aged 8 to 18 years will be enrolled into this study. Each patient will participate in the study for nine weeks. From this study an appropriate dosage will be determined to proceed with a double blinded placebo controlled study.
| Condition | Intervention | Phase |
|---|---|---|
|
Inflammatory Bowel Disease Ulcerative Colitis Crohn's Disease |
Drug: Curcumin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study |
Resource links provided by NLM:
Further study details as provided by Seattle Children's Hospital:
Primary Outcome Measures:
- To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease. [ Time Frame: 9 Weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 11 |
| Study Start Date: | May 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Curcumin
Initial dosage of 500mg twice a day for 3 weeks. Using the forced dose titration design, dose will be titrated up to 1g twice a day at Week 3 for a total of three weeks and then titrated again to 2g twice a day at Week 6 for three weeks.
Eligibility| Ages Eligible for Study: | 8 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889161
Locations
| United States, Washington | |
| Seattle Children's Hosptial | |
| Seattle, Washington, United States, 98105 | |
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
| Principal Investigator: | David Suskind, MD | Seattle Children's Hospital |
More Information
No publications provided by Seattle Children's Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David Suskind, MD, Seattle Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00889161 History of Changes |
| Other Study ID Numbers: | Curcumin-1, 1UL1RR025014-01 |
| Study First Received: | April 24, 2009 |
| Last Updated: | June 16, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Seattle Children's Hospital:
|
Crohn's disease ulcerative colitis curcumin pediatric inflammatory bowel disease |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases Intestinal Diseases Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes Curcumin Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013