NCT04225819: ACTIVATED

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

Suspended NA Last updated 9 May 2025

What this trial tests

NA trial testing Vitamin D3 in IBD in 100 participants. Suspended.

Timeline

1 October 2020

Primary endpoint
1 April 2026

1 April 2027

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Suspended
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	1 October 2020
Primary completion	1 April 2026
Estimated completion	1 April 2027
Sites	1 location across United States

Drugs / interventions tested

• Vitamin D3 (cholecalciferol) — full drug profile →
• Placebo

Conditions studied

• IBD — all drugs for IBD →
• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
• Crohn Disease — all drugs for Crohn Disease →
• Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with IBD or Inflammatory Bowel Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bile Salt Hydrolase-Competent Probiotics in the Management of IBD: Unlocking the "Bile Acid Code".
   Gadaleta RM, Cariello M, Crudele L, Moschetta A. · · 2022 · cited 39× · PMID 35956388 · DOI 10.3390/nu14153212
2. Modulation of the immunity and inflammation by autophagy.
   Gan T, Qu S, Zhang H, Zhou XJ. · · 2023 · cited 27× · PMID 37405276 · DOI 10.1002/mco2.311
3. Vitamin D for the treatment of inflammatory bowel disease.
   Wallace C, Gordon M, Sinopoulou V, Limketkai BN. · · 2023 · cited 17× · PMID 37781953 · DOI 10.1002/14651858.cd011806.pub2