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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03162432
• Other study ID #: IND 135093
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 1, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2023
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Crohn Disease
• IBD
• Ulcerative Colitis

Intervention

Drug:
• Vitamin D3
Oral Vitamin D3 therapy.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.