High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study will be to assess the safety and efficacy of high-dose interval Vitamin D3 therapy in children and young adults with Inflammatory Bowel Disease being treated with serial Remicade infusions.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Cholecalciferol; Ergocalciferols; Infliximab; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Existing diagnosis of IBD

• Age 0-25 years

• Measured serum level of 25-OH Vitamin D of 15-29 ng/ml in the last 8 weeks and no changes in Vitamin D supplementation in the interim

Exclusion Criteria:

• Pregnant Women

• History of underlying kidney disease

• History of granulomatous disease

• Inability to take oral Vitamin D

• History of hypercalcemia or hypercalciuria

• Currently taking an anti-epileptic medication

• History of pre-existing liver disease (excluding primary sclerosing cholangitis, non-alcoholic fatty liver disease, or steatohepatitis)