Clinical trial NCT03053414: Vitamin D Repletion and Maintenance in IBD: How Much and How Often
Official title: A Vitamin D Dosing Strategy for Adequate Repletion and Maintenance in IBD Patients With Minimal Disease Activity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Inflammatory Bowel Diseases
Vitamin D Deficiency
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of four treatment arms for the duration of the study. Labs will be checked every 3 months as part of standard of care to help delineate the best strategy for repletion and maintenance of Vitamin D levels throughout the study.
Primary purpose: TREATMENT

Brief 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. 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.

Detailed description: 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 or in clinical remission who have vitamin D levels \<30 ng/ml and not on any type of vitamin repletion therapy. The investigators will randomize the participants into one of four arms: (1) Oral 50,000 vitamin D IU every week for 12 weeks (2) Oral 50,000 vitamin D weekly for 12 weeks than oral 800 vitamin D IU/d (3) Oral 50,000 vitamin D IU weekly for 12 weeks then 5,000 vitamin D IU/d (4) Oral 5,000 vitamin D IU/d and check vitamin D levels and inflammatory markers as part of standard of care follow- up every 3 months for nine months. Every participant will receive dietary counseling throughout the study duration. Our aim is to identify an optimal dosing strategy for repletion and maintenance of vitamin D levels in the subset of IBD patients. Based on clinical experience, doses higher than the recommended doses for bone health are needed to achieve and maintain optimal levels of Vitamin D in IBD patients, even patients are in remission or do not have small bowel (malabsorption) involvement.

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

Primary outcomes:
measure: Vitamin D levels after completion of repletion dosing
timeFrame: 3 months
Secondary outcomes:
measure: Vitamin D levels on maintenance dosing
timeFrame: 9 months
Other outcomes:
measure: Medication compliance among participants
timeFrame: 1 year
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
References:
citation: Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
citation: Ananthakrishnan AN. Epidemiology and risk factors for IBD. Nat Rev Gastroenterol Hepatol. 2015 Apr;12(4):205-17. doi: 10.1038/nrgastro.2015.34. Epub 2015 Mar 3.
citation: Cantorna MT. Vitamin D, multiple sclerosis and inflammatory bowel disease. Arch Biochem Biophys. 2012 Jul 1;523(1):103-6. doi: 10.1016/j.abb.2011.11.001. Epub 2011 Nov 10.