Curcumin in Pediatric Inflammatory Bowel Disease

This study has been completed.
Sponsor:
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

April 24, 2009
June 16, 2010
May 2009
June 2010   (final data collection date for primary outcome measure)
To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease. [ Time Frame: 9 Weeks ] [ Designated as safety issue: Yes ]
To determine the tolerability of curcumin in pediatric patients with ulcerative colitis. [ Time Frame: 9 Weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00889161 on ClinicalTrials.gov Archive Site
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Curcumin in Pediatric Inflammatory Bowel Disease
Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • Crohn's Disease
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.
Not Provided
Suskind DL, Wahbeh G, Burpee T, Cohen M, Christie D, Weber W. Tolerability of curcumin in pediatric inflammatory bowel disease: a forced-dose titration study. J Pediatr Gastroenterol Nutr. 2013 Mar;56(3):277-9. doi: 10.1097/MPG.0b013e318276977d.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00889161
Curcumin-1, 1UL1RR025014-01
Not Provided
David Suskind, MD, Seattle Children's Hospital
Seattle Children's Hospital
Not Provided
Principal Investigator: David Suskind, MD Seattle Children's Hospital
Seattle Children's Hospital
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP