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Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED)

Primary Purpose

IBD, Inflammatory Bowel Diseases, Crohn Disease

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBD focused on measuring Vitamin D3, Cholecalciferol, IBD, Inflammatory Bowel Disease, Adjunctive treatment, Crohn's Disease, Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3 supplement

Placebo

Arm Description

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

Two placebo capsules, taken daily with a meal

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

fecal calprotectin
Stool samples will be taken at baseline and week 14 to assess change in fecal calprotectin levels
plasma 25(OH)D levels.
Plasma samples will be taken at baseline and week 14 to measure 25(OH)D levels

Full Information

First Posted
January 3, 2020
Last Updated
October 17, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04225819
Brief Title
Adjunctive Treatment With Vitamin D3 in Patients With Active IBD
Acronym
ACTIVATED
Official Title
Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Suspended
Why Stopped
Protocol is being modified.
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBD, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Vitamin D3 Deficiency
Keywords
Vitamin D3, Cholecalciferol, IBD, Inflammatory Bowel Disease, Adjunctive treatment, Crohn's Disease, Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3 supplement
Arm Type
Experimental
Arm Description
Two- 5,000 IU capsules, taken daily with a meal
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Two placebo capsules, taken daily with a meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
Softgel capsules containing 5,000 IU cholecalciferol (Vitamin D3), sunflower oil, beef gelatin, glycerin, water
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Sfotgel capsules containing sunflower oil, beef gelatin, glycerin, water
Primary Outcome Measure Information:
Title
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) outcome
Description
Patients will complete the SIBDQ questionnaire to measure disease activity at baseline, week 6 and week 14.
Time Frame
14 weeks
Title
stool microbiome in IBD patients
Description
Stool samples will be taken at baseline and week 14 to assess change in stool microbiome
Time Frame
14 weeks
Title
serum cathelicidin levels
Description
Serum samples will be taken at baseline and week 14 to measure serum cathelicidin levels
Time Frame
14 weeks
Title
HBI
Description
Patients with Crohn's Disease will complete the Harvey Bradshaw Index questionnaire to measure disease activity at baseline, week 6 and week 14
Time Frame
14 weeks
Title
SCCAI
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
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
fecal calprotectin
Description
Stool samples will be taken at baseline and week 14 to assess change in fecal calprotectin levels
Time Frame
14 weeks
Title
plasma 25(OH)D levels.
Description
Plasma samples will be taken at baseline and week 14 to measure 25(OH)D levels
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashwin Ananthakrishnan, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

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