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

NCT02256605 | Completed

• 1 other identifier: 524835
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Inflammatory Bowel Disease (IBD)

Outcome Measures

Primary Outcomes (1)

• 25 \(OH)D level will be recorded at baseline and at 8 weeks as an absolute value (ratio data) and the percentage and direction (increase or decrease) of change between baseline and end of treatment level.

  8 weeks

Study Arms (2)

Insufficient Group

D-3 Chewable Wafer - 14,000 IU/wafer weekly Vitamin D-3 Caps - 2,000 IU/Cap daily Vitamin D-3 Liquid - 5,000 IU/ml (0.4) ml daily

Dietary Supplement: Vitamin D-3

Deficient Group

D-3 Chewable Wafer - 50,000 IU/wafer weekly Vitamin D-3 Liquid - 5,000 IU/ml daily

Dietary Supplement: Vitamin D-3

Interventions

Vitamin D-3 DIETARY_SUPPLEMENT

Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a routine clinic visit or lab draw that included a 25(OH)D level as part of clinical practice/standard care. Once consent and assent are obtained, the children who are 25-hydroxyvitamin D \[259OH)D\] insufficient or deficient will be randomly assigned to a daily or weekly dosing regimen using block randomization to ensure equal group size.

Deficient Group; Insufficient Group

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a rountine clinic visit or lab draw that includes a 25(OH)D level as part of a clinical practice/standard of care.

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

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• NASPGHAN Foundation: collaborator

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 3, 2014
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 29, 2015

Record last verified: 2015-05

Locations

US (1)