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

NCT03053414 | Withdrawn

• 1 other identifier: Pro00045446
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Vitamin D levels after completion of repletion dosing

  3 months

Secondary Outcomes (1)

• Vitamin D levels on maintenance dosing

  9 months

Other Outcomes (1)

• Medication compliance among participants

  1 year

Study Arms (4)

Treatment Arm # 1

ACTIVE COMPARATOR

50,000 IU oral vitamin D2 per week for 12 weeks + Dietary counseling

Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)

Treatment Arm # 2

ACTIVE COMPARATOR

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)

Treatment Arm # 3

ACTIVE COMPARATOR

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)

Treatment Arm # 4

ACTIVE COMPARATOR

5,000 IU oral daily vitamin D3 for 9 months + Dietary counseling

Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)

Interventions

Vitamin D (ergocalciferol and/ or cholecalciferol) DIETARY_SUPPLEMENT

To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.

Treatment Arm # 1; Treatment Arm # 2; Treatment Arm # 3; Treatment Arm # 4

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• (OH)D level \<30 ng/ml within three months of study enrollment
• Provided verbal consent
• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (3)

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

  PMID: 17653185 BACKGROUND

• 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.

  PMID: 25732745 BACKGROUND

• 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.

  PMID: 22085500 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Vitamin D Deficiency

Interventions

Vitamin D; Ergocalciferols; Cholecalciferol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Director, Inflammatory Bowel Disease Program

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 15, 2017
• Study Start: February 20, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 21, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)