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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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IBD, Ulcerative Colitis, Crohn Disease

Intervention / Treatment
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* Drug: Vitamin D3


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 Treatment<br>Subjects receiving Remicade will be treated with oral Vitamin D3 | Drug: Vitamin D3<br>* Oral Vitamin D3 therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of intervention to maintain 25-OH Vitamin D levels in the 35-80 range | The study will involve measuring serum 25-OH Vitamin D levels after the initiation of open-label therapy. This will be done approximately one month after starting therapy, at the end of the study interval (one year), and as clinically indicated over the course of the year. Serum 25-OH Vitamin D levels are the most robust metric for assessing Vitamin D sufficiency. | Patients will continue to receive oral Vitamin D therapy for one year. We will be assessing the efficacy of oral Vitamin D therapy, in this dosing schema, to result in 25-OH Vitamin D levels during and at the conclusion of this one-year study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess risk of kidney stones development in patients treated with high-dose interval Vitamin D | Patients will provide a spot urine collection the day prior to their Remicade infusion. A second spot urine collection will be collected on the day of the infusion. Urinary calcium excretion will be assessed. Changes in urinary calcium excretion will be used to identify subjects at risk for the development of renal stones. | Patients will be monitored for urinary symptoms and complete serial urine assessments as outlined in the protocol. The impact of oral Vitamin D administration on calcium excretion will be evaluated during and at the conclusion of this one-year study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD