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NCT Number: NCT04331639

High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy

The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.

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Key information

Conditions

Inflammatory Bowel Disease Avitaminosis Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Deficiency Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Ulcerative Colitis Vitamin D Deficiency

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Rebecca Gordon, MD

CONTACT

About this study

The investigators will be administering oral high dose interval vitamin D3 concurrently when participants with inflammatory bowel disease (IBD) are receiving biologic therapy every 4-8 weeks. The investigators will collect additional bloodwork when participants are getting clinical labwork in order to assess markers of bone health and inflammation in response to vitamin D treatment. The investigators will serially assess with questionnaires associated measures, including dietary vitamin D and calcium intake, sunlight exposure, physical activity, fracture history, IBD disease activity, and overall health.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

Subjects will receive oral high dose interval vitamin D3, concurrently when they are receiving their biologic treatment for their inflammatory bowel disease every 4-8 weeks.

Other names: cholecalciferol

Primary outcomes

  1. vitamin D target

    Time frame: at study conclusion, up to 64 weeks

    assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL

Secondary outcomes

  1. change in vitamin D level

    Time frame: at study conclusion, up to 64 weeks

    assess change in serum 25-OHD level from study entry to study conclusion

  2. vitamin D binding protein

    Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)

    assessing vitamin D binding protein and free vitamin D

  3. parathyroid hormone

    Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)

    assessing parathyroid hormone

  4. serum safety parameter

    Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)

    evaluate serum calcium level

  5. urine safety parameter

    Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)

    evaluate urinary calcium to creatinine ratio

  6. bone mineral density

    Time frame: at study conclusion, up to 64 weeks, when clinically available

    assess changes in bone density and body composition as assessed by DXA scan, when clinically available

  7. markers of bone turnover

    Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)

    evaluating bone turnover markers such as c-telopeptide, bone specific alkaline phosphatase, osteocalcin, and N-terminal propeptide of type 1 procollagen. May do some of these, and then depending upon the results, consider doing additional analytes, as exploratory analysis.

  8. inflammatory bowel disease treatment parameters

    Time frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)

    assess level of Inflixmab, including antibodies to Infliximab and Infliximab levels, when clinically available

  9. cytokine measurements

    Time frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)

    evaluating pro-inflammatory and anti-inflammatory cytokine levels, specifically interleukin-17 and interferon gamma, with likely additional exploratory studies to further characterize immune response to vitamin D repletion depending upon these results.

  10. 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

    evaluating c-reactive protein

  11. 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

    evaluating erythrocyte sedimentation rate

  12. 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)

    assess quality of life measures in children with inflammatory bowel disease

  13. baseline questionnaire on overall health

    Time frame: at 0 weeks (entry into study)

    assess overall health questionnaire

  14. fracture history questionnaire

    Time frame: at 0 weeks (entry into study)

    assess fracture history

  15. food frequency questionnaire

    Time frame: at 0 weeks (entry into study)

    assess calcium and vitamin D food frequency

  16. physical activity questionnaire

    Time frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)

    assess physical activity level

  17. sun exposure questionnaire

    Time frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)

    assess sunlight exposure

  18. 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)

    assess for any changes in inflammatory bowel disease treatment since last visit

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Gordon, MD

CONTACT

[email protected]

617-355-7476

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 2, 2020
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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