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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

ACTIVE_NOT_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

PHASE3

Gender

ALL

Min Age

7 Years

Max Age

25 Years

Download Date

2023-10-10

Principal Investigator

N/A

Primary Contact Information

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

Contact

For more information and to contact the study team:

High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade NCT03162432