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Search / Trial NCT03053414

Vitamin D Repletion and Maintenance in IBD: How Much and How Often

Launched by CEDARS-SINAI MEDICAL CENTER · Feb 10, 2017

Trial Information

Current as of May 27, 2025

Withdrawn

Keywords

ClinConnect Summary

Inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), are chronic relapsing inflammatory conditions of the gastrointestinal tract. IBD is thought to result from a complex interaction between genetic, immune, microbial and environmental factors. The role of vitamin D in bone health and calcium homeostasis is well documented. However, emerging data suggests that vitamin D may also regulate immune responses, which may play a role in the pathogenesis and disease activity of IBD.

The investigators seek to identify CD or UC patients with mild disease ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Diagnosis of Crohn's disease or Ulcerative colitis
  • 2. In clinical remission or with mild disease activity as determined by the Harvey Bradshaw Index (CD) ≤7 or Ulcerative Colitis disease activity index ≤6.
  • 3. 25(OH)D level \<30 ng/ml within three months of study enrollment
  • 4. Provided verbal consent
  • 5. 18 years of age or older
  • Exclusion Criteria:
  • 1. Unwilling to provide consent or lack capacity
  • 2. Moderate to severe disease activity (Harvey Bradshaw index \>7 or UCDAI \>6)
  • 3. Current pregnancy or attempting to conceive
  • 4. Known coexisting hyperparathyroidism
  • 5. Already on vitamin D supplementation, calcium supplementation or a multivitamin
  • 6. BMI \>30 kg/m²
  • 7. History of kidney stones
  • 8. Subjects \<18 years of age - pediatric population with different recommended dosing than adults (10).
  • 9. Non-english speakers

About Cedars Sinai Medical Center

Cedars-Sinai Medical Center is a renowned nonprofit academic medical center located in Los Angeles, California, recognized for its commitment to patient care, research, and education. As a leading institution in clinical trials, Cedars-Sinai harnesses innovative approaches to advance medical knowledge and improve treatment outcomes across various specialties. With a multidisciplinary team of experts, state-of-the-art facilities, and a patient-centered approach, Cedars-Sinai actively contributes to the development of novel therapies and interventions, ensuring the highest standards of clinical research while prioritizing patient safety and ethical considerations.

Locations

Los Angeles, California, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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