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LL-37

Cathelicidin, hCAP-18, FALL-39, CAP-18

Quick Stats
Studies 2230
Trials 95
Suspended NA INTERVENTIONAL NCT04225819

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: Vitamin D3
Type: DIETARY_SUPPLEMENT
Description: Softgel capsules containing 5,000 IU cholecalciferol (Vitamin D3), sunflower oil, beef gelatin, glycerin, water
Name: Placebo
Type: OTHER
Description: Sfotgel capsules containing sunflower oil, beef gelatin, glycerin, water

Primary Outcomes

Measure: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) outcome
TimeFrame: 14 weeks
Description: Patients will complete the SIBDQ questionnaire to measure disease activity at baseline, week 6 and week 14.
Measure: stool microbiome in IBD patients
TimeFrame: 14 weeks
Description: Stool samples will be taken at baseline and week 14 to assess change in stool microbiome
Measure: serum cathelicidin levels
TimeFrame: 14 weeks
Description: Serum samples will be taken at baseline and week 14 to measure serum cathelicidin levels
Measure: HBI
TimeFrame: 14 weeks
Description: Patients with Crohn's Disease will complete the Harvey Bradshaw Index questionnaire to measure disease activity at baseline, week 6 and week 14
Measure: SCCAI
TimeFrame: 14 weeks
Description: Patients with Ulcerative Colitis will complete the Simple Clinical Colitis Activity Index questionnaire to measure disease activity at baseline, week 6 and week 14

Trial Information

NCT ID

NCT04225819

Status

Suspended

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Massachusetts General Hospital

Last Updated

December 15, 2025