Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

NCT04225819 | Suspended

• 1 other identifier: 2019P003843
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory bowel disease ((IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC)), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The incidence of IBD is increasing worldwide and poses as a burden that reduces quality of life and has a significant impact on health care resources. The advent of monoclonal antibodies to tumor necrosis factor-α (anti-TNF) has revolutionized treatment of IBD, improving rates of remission and reducing hospitalizations and surgeries. Nevertheless, many patients do not adequately respond to these therapies or lose response over time. Thus, there is an important need for novel immunomodulating agents to improve our ability to achieve remission. Besides its traditional role in bone homeostasis, several studies have recognized the important role Vitamin D plays in modulating the immune response, cancer, and cardiovascular disease. Specifically, Vitamin D may mediate immunity by modulating autophagy in leukocytes and regulating the gut microbiome. Thus, Vitamin D may play an important role in IBD. Furthermore, evidence suggests that the effect of vitamin D may be mediated through the TNF-α pathway, suggesting a synergy with anti-TNF therapy. This is a randomized, double blind, placebo-controlled trial to study the effect of Vitamin D3 as an adjunct therapy for patients with active CD, UC, or IBD unspecified who are undergoing anti-TNF induction therapy.

Conditions

IBD; Crohn Disease; Ulcerative Colitis; Vitamin D3 Deficiency; Inflammatory Bowel Diseases

Keywords

Vitamin D3; Cholecalciferol; IBD; Inflammatory Bowel Disease; Adjunctive treatment; Crohn's Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (5)

• Short Inflammatory Bowel Disease Questionnaire (SIBDQ) outcome

  Patients will complete the SIBDQ questionnaire to measure disease activity at baseline, week 6 and week 14.

  14 weeks

• stool microbiome in IBD patients

  Stool samples will be taken at baseline and week 14 to assess change in stool microbiome

  14 weeks

• serum cathelicidin levels

  Serum samples will be taken at baseline and week 14 to measure serum cathelicidin levels

  14 weeks

• HBI

  Patients with Crohn's Disease will complete the Harvey Bradshaw Index questionnaire to measure disease activity at baseline, week 6 and week 14

  14 weeks

• SCCAI

  Patients with Ulcerative Colitis will complete the Simple Clinical Colitis Activity Index questionnaire to measure disease activity at baseline, week 6 and week 14

  14 weeks

Secondary Outcomes (2)

• fecal calprotectin

  14 weeks

• plasma 25(OH)D levels.

  14 weeks

Study Arms (2)

Vitamin D3 supplement

EXPERIMENTAL

Two- 5,000 IU capsules, taken daily with a meal

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

Two placebo capsules, taken daily with a meal

Other: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Softgel capsules containing 5,000 IU cholecalciferol (Vitamin D3), sunflower oil, beef gelatin, glycerin, water

Also known as: cholecalciferol

Vitamin D3 supplement

Placebo OTHER

Sfotgel capsules containing sunflower oil, beef gelatin, glycerin, water

Placebo

Eligibility Criteria

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

You may qualify if:

• Established diagnosis of CD, UC, or IBD-unspecified
• Initiating anti-TNF therapy for IBD within 2 weeks of baseline/randomization
• Other non-anti-TNF IBD medications must remain stable during the treatment period with the exception of tapering of corticosteroids.
• Recent (within 6 months) objective evidence of active IBD on colonoscopy along with elevated inflammatory markers (C-reactive protein \>8 mg/L or fecal calprotectin \>150 mcg/g)
• Current disease activity defined as a Harvey Bradshaw index \> 4 at baseline (week 0) for CD subjects or Simple Clinical Colitis Activity Index \> 2 at baseline (week 0) for UC subjects.
• Fecal Calprotectin level \>150 mcg/g

You may not qualify if:

• Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study.
• Female subjects who are pregnant, lactating, or intending to become pregnant during the study period
• Known intolerance or hypersensitivity to oral vitamin D3 supplementation
• Plasma 25(OH)D \> 60 ng/mL
• Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
• Serum calcium \>11 mg/dL
• History of hyperparathyroidism
• History of renal calculi or chronic kidney disease
• Initiation of anti-TNF treatment for extra-intestinal symptoms alone
• Evidence of untreated infection (e.g. Clostridium difficile)
• History of chronic pancreatitis
• History of cystic fibrosis
• History of gastric bypass
• Presence of stoma or J-pouch

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ashwin Ananthakrishnan, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 13, 2020
• Study Start: October 1, 2020
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)