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Vitamin D3 Supplementation in Pediatric IBD: Weely vs Daily Dosing Regimens

Sponsored by Nemours Children's Clinic

Phase Quota
Phase N/A

The purpose of this prospecitve randomized controlled trial is to compare effectiveness and patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D [25(OH)D] insufficient or deficient. The primary aim of this pilot study is to evaluate the effectiveness of once weekly verses daily D-3 dosing regimens based on the most current IBD supplementation guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is difference in adherence between dosing regimns.

Study Start Date: November 2013

Estimated Completion Date: May 2015

Specialties: Gastroenterology: Inflammatory Bowel Dz Family Medicine: Preventive/Nutrition Nurse Practitioner: Nutrition Physician Assistant: Gastroenterology

Interventions

  • Dietary Supplement: Vitamin D-3

Inclusion criteria

  • Subjects aged 5 to 17 years with a diagnosis of Inflammatory Bowel Disease, who have a 25(OH)D level below 30 ng/ml within 2 weeks of enrollment
  • Subject/family must be able and willing to take oral medications, complete a 3 day dietary record, and return for 8 week concluding visit or clinicl visit

Exclusion criteria

  • Subjects will not be eligible if they are intolerant of vitamin supplementation or any ingredients in the chosen supplment, are unable or unwilling to take oral supplements, or are on specific medical therapy for diminished bone mineral density
  • Children with parathryoid disease, granulomatous disorders or William's syndrome will also be excluded from the study

Study Locations And Contact Information

  • Nemours Childrens Clinic, Jacksonville Florida

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