Status:

COMPLETED

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

Lead Sponsor:

Nemours Children's Clinic

Collaborating Sponsors:

NASPGHAN Foundation

Conditions:

Inflammatory Bowel Disease (IBD)

Eligibility:

All Genders

5-17 years

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 1 2015

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT02256605

Start Date

November 1 2013

End Date

May 1 2015

Last Update

May 29 2015

Active Locations (1)

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Nemours Children's Clinic

Jacksonville, Florida, United States, 32207