Back to resultsHigh Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade
Primary Purpose
IBD, Ulcerative Colitis, Crohn Disease
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
About this trial
This is an interventional treatment trial for IBD focused on measuring IBD
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)
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vitamin D3 Treatment
Arm Description
Subjects receiving Remicade will be treated with oral Vitamin D3
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03162432
First Posted
May 15, 2017
Last Updated
October 8, 2023
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03162432
Brief Title
High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade
Official Title
High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBD, Ulcerative Colitis, Crohn Disease
Keywords
IBD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3 Treatment
Arm Type
Experimental
Arm Description
Subjects receiving Remicade will be treated with oral Vitamin D3
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Intervention Description
Oral Vitamin D3 therapy.
Primary Outcome Measure Information:
Title
Ability of intervention to maintain 25-OH Vitamin D levels in the 35-80 range
Description
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.
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.
Secondary Outcome Measure Information:
Title
Assess risk of kidney stones development in patients treated with high-dose interval Vitamin D
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35045559
Citation
Gordon RJ, Wells R, Johansen C, Liu S, Dahlberg SE, Snapper SB, Rufo PA. Efficacy and Safety of High-dose Cholecalciferol in Patients With Inflammatory Bowel Disease Receiving Infliximab. J Pediatr Gastroenterol Nutr. 2022 Apr 1;74(4):476-483. doi: 10.1097/MPG.0000000000003386. Epub 2022 Jan 18.
Results Reference
derived
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High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade
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