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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Inflammatory Bowel Diseases; Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Arm # 1; 50,000 IU oral vitamin D2 per week for 12 weeks + Dietary counseling	Dietary supplement: Vitamin D (ergocalciferol and/ or cholecalciferol); To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.
Active Comparator: Treatment Arm # 2; 50,000 IU oral vitamin D2 per week x 12 weeks then 800 IU/day oral vitamin D3 for 6 months + Dietary counseling	Dietary supplement: Vitamin D (ergocalciferol and/ or cholecalciferol); To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.
Active Comparator: Treatment Arm # 3; 50,000 IU oral vitamin D2 per week x 12 weeks then 5,000 IU/day oral vitamin D3 for 6 months+ Dietary counseling	Dietary supplement: Vitamin D (ergocalciferol and/ or cholecalciferol); To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.
Active Comparator: Treatment Arm # 4; 5,000 IU oral daily vitamin D3 for 9 months + Dietary counseling	Dietary supplement: Vitamin D (ergocalciferol and/ or cholecalciferol); To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vitamin D levels after completion of repletion dosing	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Vitamin D levels on maintenance dosing	9 months

Other Outcome Measures

Outcome Measure	Time Frame
Medication compliance among participants	1 year

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• 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.
• Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 10, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Nutrition Disorders; Gastroenteritis; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Inflammatory Bowel Diseases; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Ergocalciferols
• Other Study ID Numbers: Pro00045446

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No