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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2023-12-01

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.

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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.

Conditions

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IBD Ulcerative Colitis Crohn Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D3 Treatment

Subjects receiving Remicade will be treated with oral Vitamin D3

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

Oral Vitamin D3 therapy.

Interventions

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Vitamin D3

Oral Vitamin D3 therapy.

Intervention Type DRUG

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)

Minimum Eligible Age

7 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No