Your session is about to expire
← Back to Search
Vitamin D3 for Inflammatory Bowel Disease (ACTIVATED Trial)
N/A
Waitlist Available
Led By Ashwin Ananthakrishnan, MD, MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Other non-anti-TNF IBD medications must remain stable during the treatment period with the exception of tapering of corticosteroids.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights
ACTIVATED Trial Summary
This trial is studying whether giving vitamin D3 to patients with inflammatory bowel disease (IBD) will improve their response to anti-tumor necrosis factor (anti-TNF) therapy.
Eligible Conditions
- Inflammatory Bowel Disease
- Ulcerative Colitis
- Vitamin D Deficiency
- Crohn's Disease
ACTIVATED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You cannot change the dose of your medications for inflammatory bowel disease, except for gradually reducing corticosteroids.
ACTIVATED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HBI
SCCAI
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) outcome
+2 moreSecondary outcome measures
fecal calprotectin
plasma 25(OH)D levels.
ACTIVATED Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vitamin D3 supplementExperimental Treatment1 Intervention
Two- 5,000 IU capsules, taken daily with a meal
Group II: PlaceboPlacebo Group1 Intervention
Two placebo capsules, taken daily with a meal
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D3
2011
Completed Phase 4
~3590
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,925 Previous Clinical Trials
13,197,803 Total Patients Enrolled
Ashwin Ananthakrishnan, MD, MPHPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
Jawaharlal Inst Of Post-Grad Medical Educ (Medical School)
Medical College Wi Affil Hosps, Inc (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot change the dose of your medications for inflammatory bowel disease, except for gradually reducing corticosteroids.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin D3 supplement
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum number of participants for this clinical investigation?
"Affirmative. According to the information located on clinicaltrials.gov, this research trial is currently recruiting volunteers. It was initially created on October 1st 2020 and last modified April 4th 2022; it requires 100 participants from one site."
Answered by AI
Does the research team at present have any slots available to volunteer?
"Data on clinicaltrials.gov confirms that the recruitment for this medical trial is ongoing; it was initially posted in October 2020 and last revised in April 2022."
Answered by AI
Share this study with friends
Copy Link
Messenger