Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED)
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|ClinicalTrials.gov Identifier: NCT04225819|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : February 24, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|IBD Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Vitamin D3 Deficiency||Dietary Supplement: Vitamin D3 Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||April 1, 2023|
|Estimated Study Completion Date :||April 1, 2024|
Experimental: Vitamin D3 supplement
Two- 5,000 IU capsules, taken daily with a meal
Dietary Supplement: Vitamin D3
Softgel capsules containing 5,000 IU cholecalciferol (Vitamin D3), sunflower oil, beef gelatin, glycerin, water
Other Name: cholecalciferol
Placebo Comparator: Placebo
Two placebo capsules, taken daily with a meal
Sfotgel capsules containing sunflower oil, beef gelatin, glycerin, water
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ) outcome [ Time Frame: 14 weeks ]Patients will complete the SIBDQ questionnaire to measure disease activity at baseline, week 6 and week 14.
- stool microbiome in IBD patients [ Time Frame: 14 weeks ]Stool samples will be taken at baseline and week 14 to assess change in stool microbiome
- serum cathelicidin levels [ Time Frame: 14 weeks ]Serum samples will be taken at baseline and week 14 to measure serum cathelicidin levels
- HBI [ Time Frame: 14 weeks ]Patients with Crohn's Disease will complete the Harvey Bradshaw Index questionnaire to measure disease activity at baseline, week 6 and week 14
- SCCAI [ Time Frame: 14 weeks ]Patients with Ulcerative Colitis will complete the Simple Clinical Colitis Activity Index questionnaire to measure disease activity at baseline, week 6 and week 14
- fecal calprotectin [ Time Frame: 14 weeks ]Stool samples will be taken at baseline and week 14 to assess change in fecal calprotectin levels
- plasma 25(OH)D levels. [ Time Frame: 14 weeks ]Plasma samples will be taken at baseline and week 14 to measure 25(OH)D levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04225819
|Contact: Kelly Lingfirstname.lastname@example.org|
|Contact: Rachel Glasseremail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Ashwin Ananthakrishnan, MD, MPH||Massachusetts General Hospital|