NCT00889161

Curcumin in Pediatric Inflammatory Bowel Disease

Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Disease
• Ulcerative Colitis
• Crohn's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-04-28
• Last updated: 2010-06-22

Locations

1 site across 1 country: United States