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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 February 2021
Main ID:  NCT04331639
Date of registration: 23/03/2020
Prospective Registration: Yes
Primary sponsor: Boston Children's Hospital
Public title: High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
Scientific title: Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab
Date of first enrolment: November 1, 2020
Target sample size: 50
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04331639
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Rebecca Gordon, MD
Address: 
Telephone:
Email:
Affiliation: 
Name:     Rebecca Gordon, MD
Address: 
Telephone: 617-355-7476
Email: rebecca.gordon@childrens.harvard.edu
Affiliation: 
Name:     Rebecca Gordon, MD
Address: 
Telephone:
Email:
Affiliation:  Boston Children's Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, and
indeterminate colitis

- Receiving treatment with Infliximab or Vedolizumab every 4-8 weeks

- Age 5-25 years old, at study entry

- Measured serum level of 25-OHD of less than 40 ng/mL in the last 4-8 weeks and no
changes in vitamin D supplementation in the interim. Of note, 25-OHD levels are
evaluated routinely as part of standard clinical care for IBD

Exclusion Criteria:

- History of any underlying kidney disease

- History of preexisting liver disease

- History of granulomatous disease

- Inability to take oral vitamin D3 as a pill

- History of hypercalcemia or hypercalciuria

- Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix



Age minimum: 5 Years
Age maximum: 25 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Inflammatory Bowel Disease
Ulcerative Colitis
Vitamin D Deficiency
Intervention(s)
Dietary Supplement: vitamin D3
Primary Outcome(s)
vitamin D target [Time Frame: at study conclusion, up to 64 weeks]
Secondary Outcome(s)
baseline questionnaire on overall health [Time Frame: at 0 weeks (entry into study)]
bone mineral density [Time Frame: at study conclusion, up to 64 weeks, when clinically available]
c-reactive protein [Time Frame: at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available]
change in vitamin D level [Time Frame: at study conclusion, up to 64 weeks]
cytokine measurements [Time Frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)]
erythrocyte sedimentation rate [Time Frame: at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available]
follow-up questionnaire on overall health [Time Frame: at 4 weeks to up to 64 weeks, at all study visits except the initial visit (0 weeks)]
food frequency questionnaire [Time Frame: at 0 weeks (entry into study)]
fracture history questionnaire [Time Frame: at 0 weeks (entry into study)]
health-related quality of life questionnaire for inflammatory bowel disease [Time Frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)]
inflammatory bowel disease treatment parameters [Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
markers of bone turnover [Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
parathyroid hormone [Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
physical activity questionnaire [Time Frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)]
serum safety parameter [Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
sun exposure questionnaire [Time Frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)]
urine safety parameter [Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
vitamin D binding protein [Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)]
Secondary ID(s)
P00033424
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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