← 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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

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 more

Secondary 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

0 / 1Eligibility criteria met

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

Vitamin D3 Clinical Trial Eligibility Overview. Trial Name: NCT04225819 — N/A

Inflammatory Bowel Disease Research Study Groups: Vitamin D3 supplement, Placebo

Inflammatory Bowel Disease Clinical Trial 2023: Vitamin D3 Highlights & Side Effects. Trial Name: NCT04225819 — N/A

Vitamin D3 2023 Treatment Timeline for Medical Study. Trial Name: NCT04225819 — N/A

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

Recent research and studies

clinicaltrials.govStudy

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

Ashwin Ananthakrishnan 2020. "Adjunctive Treatment With Vitamin D3 in Patients With Active IBD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04225819.