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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
Sponsor:
Information provided by (Responsible Party):
Ashwin Ananthakrishnan, Massachusetts General Hospital

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
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
Other: Placebo
Sfotgel capsules containing sunflower oil, beef gelatin, glycerin, water




Primary Outcome Measures :
  1. 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.

  2. 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

  3. serum cathelicidin levels [ Time Frame: 14 weeks ]
    Serum samples will be taken at baseline and week 14 to measure serum cathelicidin levels

  4. 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

  5. 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


Secondary Outcome Measures :
  1. fecal calprotectin [ Time Frame: 14 weeks ]
    Stool samples will be taken at baseline and week 14 to assess change in fecal calprotectin levels

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Kelly Ling 6177247559 kling1@mgh.harvard.edu
Contact: Rachel Glasser 6176439374 rglasser@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Ashwin Ananthakrishnan, MD, MPH Massachusetts General Hospital
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Responsible Party: Ashwin Ananthakrishnan, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04225819    
Other Study ID Numbers: 2019P003843
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ashwin Ananthakrishnan, Massachusetts General Hospital:
Vitamin D3
Cholecalciferol
IBD
Inflammatory Bowel Disease
Adjunctive treatment
Crohn's Disease
Ulcerative Colitis
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents