Vitamin D Repletion and Maintenance in IBD: How Much and How Often
Withdrawn before enrolling · Not applicable
Conditions studied: Inflammatory Bowel Diseases, Vitamin D Deficiency
In brief
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. There is emerging data suggesting Vitamin D may not only play a role in bone health but may also be involved in gut health as well. While there are guidelines regarding the recommending doses of Vitamin D for supplementation and maintenance in bone health, these strategies are unknown in those with inflammatory bowel disease. The investigators seek to determine a dosing strategy for this population using doses within the recommended guidelines for bone health.
Key facts
- Study ID
- NCT03053414
- Run by
- Cedars-Sinai Medical Center
- People needed
- 0
- Starts
- 2017-02-20
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2018-03-21
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Crohn's disease or Ulcerative colitis
- In clinical remission or with mild disease activity as determined by the Harvey Bradshaw Index (CD) ≤7 or Ulcerative Colitis disease activity index ≤6.
- 25(OH)D level <30 ng/ml within three months of study enrollment
- Provided verbal consent
- 18 years of age or older
You may not qualify if…
- Unwilling to provide consent or lack capacity
- Moderate to severe disease activity (Harvey Bradshaw index >7 or UCDAI >6)
- Current pregnancy or attempting to conceive
- Known coexisting hyperparathyroidism
- Already on vitamin D supplementation, calcium supplementation or a multivitamin
- BMI >30 kg/m²
- History of kidney stones
- Subjects <18 years of age - pediatric population with different recommended dosing than adults (10).
- Non-english speakers
Where it is running
- Cedars Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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