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

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ClinicalTrials.gov Identifier: NCT03162432
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : September 20, 2019
Sponsor:
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)
Estimated Enrollment : 50 participants
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
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021

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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03162432


Contacts
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Contact: Paul A Rufo 6174692620 paul.rufo@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Paul A. Rufo, MD, MMSc    617-355-2962    paul.rufo@childrens.harvard.edu   
Principal Investigator: Paul A. Rufo, MD, MMSc         
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Paul A Rufo    617-469-2620    paul.rufo@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children’s Hospital

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Responsible Party: Paul Rufo, Assistant Professor of Pediatrics, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03162432     History of Changes
Other Study ID Numbers: IND 135093
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
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:
IBD
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Infliximab
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents