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

Completed

Conditions studied: Inflammatory Bowel Disease (IBD)

In brief

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.

Key facts

Study ID

NCT02256605

Run by

Nemours Children's Clinic

People needed

40

Starts

2013-11-01

Expected to finish

2015-05-01

Last updated by the study team

2015-05-29

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Nemours Children's Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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