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Curcumin in Pediatric Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT00889161
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : June 22, 2010
Sponsor:
Information provided by:
Seattle Children's Hospital

Tracking Information
First Submitted Date  ICMJE April 24, 2009
First Posted Date  ICMJE April 28, 2009
Last Update Posted Date June 22, 2010
Study Start Date  ICMJE May 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2009)
To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease. [ Time Frame: 9 Weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2009)
To determine the tolerability of curcumin in pediatric patients with ulcerative colitis. [ Time Frame: 9 Weeks ]
Change History Complete list of historical versions of study NCT00889161 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin in Pediatric Inflammatory Bowel Disease
Official Title  ICMJE Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • Crohn's Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2010)
11
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2009)
20
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, 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 NCT00889161
Other Study ID Numbers  ICMJE Curcumin-1
1UL1RR025014-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Suskind, MD, Seattle Children's Hospital
Study Sponsor  ICMJE Seattle Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Suskind, MD Seattle Children's Hospital
PRS Account Seattle Children's Hospital
Verification Date June 2010

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