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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    50
  • sponsor
    Boston Children's Hospital
Updated on 9 August 2022
cholecalciferol
inflammatory bowel disease
vitamin
enteropathy
remicade
bowel dysfunction
intestinal diseases

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.

Description

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.

Details
Condition IBD, Ulcerative Colitis, Crohn Disease
Treatment Vitamin D3
Clinical Study IdentifierNCT03162432
SponsorBoston Children's Hospital
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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