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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03162432
Recruitment Status : Completed
First Posted : May 22, 2017
Last Update Posted : December 4, 2020
Information provided by (Responsible Party):
Paul Rufo, Boston Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
IBD Ulcerative Colitis Crohn Disease Drug: Vitamin D3 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D3 Treatment
Subjects receiving Remicade will be treated with oral Vitamin D3
Drug: Vitamin D3
Oral Vitamin D3 therapy.

Primary Outcome Measures :
  1. Ability of intervention to maintain 25-OH Vitamin D levels in the 35-80 range [ Time Frame: 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. ]
    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.

Secondary Outcome Measures :
  1. Assess risk of kidney stones development in patients treated with high-dose interval Vitamin D [ Time Frame: 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. ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03162432

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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
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Responsible Party: Paul Rufo, Assistant Professor of Pediatrics, Boston Children's Hospital Identifier: NCT03162432    
Other Study ID Numbers: IND 135093
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paul Rufo, Boston Children's Hospital:
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Vitamin D
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents