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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.

Conditions

IBD, Ulcerative Colitis, Crohn Disease

Recruitment Status

Recruiting

Detailed 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.

Eligibility 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)

Intervention

Intervention Type

Intervention Name

Drug

Vitamin D3

Phase

Phase 3

Gender

All

Min Age

7 Years

Max Age

25 Years

Download Date

August 8, 2022

Principal Investigator

Web

Primary Contact Information

Paul A Rufo

6174692620

paul.rufo@childrens.harvard.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: