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

Clinical Trial ID: NCT03162432

Description

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.

Study subjects will receiving 50,000 units of Vitamin D3 if they receive Remicade infusions every 4-6 weeks. Study subjects will receiving 100,000 units of Vitamin D3 if they receive Remicade infusions every 6-8 weeks.


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)

  • Start Date

    2017-08-01

  • Last Updated

    2018-05-24

  • Sponsor

    Boston Children’s Hospital

  • Condition Name

    Crohn Disease

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