Vitamin D3 Supplementation in Pediatric IBD: Weely vs Daily Dosing Regimens
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS), Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 7/11/2015 |
| Start Date: | November 2013 |
| End Date: | March 2015 |
| Contact: | Shari Huffman, ARNP |
| Email: | huffman.shari@nemours.org |
| Phone: | 904-697-3756 |
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.
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.
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
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