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

Inflammatory Bowel Diseases Clinical Trial

Official title:

A Vitamin D Dosing Strategy for Adequate Repletion and Maintenance in IBD Patients With Minimal Disease Activity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03053414
• Other study ID #: Pro00045446
• Status: Withdrawn
• Phase: N/A
• First received: February 6, 2017
• Last updated: March 19, 2018
• Start date: February 20, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: March 2018
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D (ergocalciferol and/ or cholecalciferol)
To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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. Review. — View Citation

Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication compliance among participants		1 year
Primary	Vitamin D levels after completion of repletion dosing		3 months
Secondary	Vitamin D levels on maintenance dosing		9 months