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Vitamin

Vitamin D + Fish Oil for Health Improvement (VITAL Trial)

N/A

Waitlist Available

Led By Karen H Costenbader, MD, MPH

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

As for the parent trial, VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259). Individuals with chronic, frequent knee pain at study baseline will be followed as a subcohort. Trial enrollment complete

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up extension of follow-up through 7 years post trial closure

Awards & highlights

VITAL Trial Summary

This trial is studying whether taking daily dietary supplements of vitamin D3 or omega-3 fatty acids reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.

Who is the study for?

This trial is for U.S. men and women without a history of cancer, heart disease, or stroke. It's focused on those with chronic knee pain due to conditions like rheumatoid arthritis and aims to see if vitamin D3 or fish oil supplements can help.Check my eligibility

What is being tested?

The study tests whether daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce the risk of autoimmune diseases, lower inflammation markers, or alleviate chronic knee pain in participants.See study design

What are the potential side effects?

Potential side effects from taking these supplements may include an upset stomach, fishy aftertaste from the fish oil, and possibly high calcium levels from too much vitamin D.

VITAL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

VITAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ extension of follow-up through 7 years post trial closure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~extension of follow-up through 7 years post trial closure

This trial's timeline: 3 weeks for screening, Varies for treatment, and extension of follow-up through 7 years post trial closure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Autoimmune Diseases

Serum Levels of Biomarkers of Systemic Inflammation: C-reactive Protein (CRP)

Serum Levels of Biomarkers of Systemic Inflammation: Interleukin-6 (IL-6)

+2 more

Secondary outcome measures

Incident Autoimmune Disease

Other outcome measures

Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With Vitamin D

Severity of Knee Pain in Subsample With Chronic, Frequent Knee Pain at Baseline- With n-3 FA

Side effects data

From 2016 Phase 4 trial • 1366 Patients • NCT01709110

12%

Back pain

Arthralgia

Fall

Hip fracture

Humerus fracture

Lumbar vertebral fracture

Osteoarthritis

Femur fracture

100%

80%

60%

40%

20%

Study treatment Arm

Risedronate

Teriparatide

VITAL Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Vitamin D and Fish OilExperimental Treatment2 Interventions

Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).

Group II: Vitamin DExperimental Treatment2 Interventions

Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.

Group III: Fish OilExperimental Treatment2 Interventions

Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).

Group IV: placeboPlacebo Group1 Intervention

Subjects will receive placebo pill.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omega-3 fatty acids

FDA approved

Vitamin D

2013

Completed Phase 4

~3470

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,608 Previous Clinical Trials

11,444,006 Total Patients Enrolled

23 Trials studying Rheumatoid Arthritis

563,116 Patients Enrolled for Rheumatoid Arthritis

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

483 Previous Clinical Trials

1,061,069 Total Patients Enrolled

44 Trials studying Rheumatoid Arthritis

535,136 Patients Enrolled for Rheumatoid Arthritis

Karen H Costenbader, MD, MPHPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Vitamin D (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT01351805 — N/A

Rheumatoid Arthritis Research Study Groups: placebo, Fish Oil, Vitamin D, Vitamin D and Fish Oil

Rheumatoid Arthritis Clinical Trial 2023: Vitamin D Highlights & Side Effects. Trial Name: NCT01351805 — N/A

Vitamin D (Vitamin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01351805 — N/A

Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT01351805 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment have open enrollment at the present?

"Clinicaltrials.gov details that this medical trial is not actively taking on participants at the current moment. First posted on July 1st 2010 and last updated on September 16th 2022, it has yet to renew its recruitment period. Despite that, there are still 1359 other studies recruiting patients right now."

Answered by AI

What is the targeted participant population for this research endeavor?

"This trial is no longer actively seeking patients. It was initially posted on July 1st 2010 and last updated September 16th 2022; however, there are other active trials that may be of interest to you. 1338 different studies concerning inflammation have open recruitment slots and 21 for Vitamin d treatments as well."

Answered by AI

Is this an original research endeavor?

"Research into Vitamin d has been ongoing since 2005, with the initial trial sponsored by Abbott. After 15480 participants in that first study, Phase 4 drug registration was granted and now there are 21 active studies happening across 10 urban centres and 13 nations globally."

Answered by AI

What is the usual indication for Vitamin D supplementation?

"Vitamin d can be utilized to ameliorate hyperlipidemia, in addition to being applied as a nutritional supplement and dietary therapy."

Answered by AI

Are there other research initiatives exploring Vitamin D's efficacy?

"Currently, 21 clinical research projects are being conducted on Vitamin d. 6 of these trials have reached Phase 3 status. These investigations are mainly based in the city of Boston but span 66 sites across America."

Answered by AI