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Dietary Supplement

Vitamin D + Omega-3 for Osteoporosis and Body Composition (VITAL Trial)

N/A

Waitlist Available

Led By Meryl S LeBoff, M.D.

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

Those who are using bisphosphonates currently or within the past 2 years, or other bone-active medications currently or within the past year are not eligible for this study

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

VITAL Trial Summary

This trialis testing whether taking vitamin D and fish oil supplements prevents cancer, heart disease, and stroke in 25,871 U.S. men and women without prior illnesses. It also looks at the safety and efficacy of high-dose vitamin D on skeletal health and body composition.

Who is the study for?

The VITAL trial is for U.S. men and women who are part of the larger VITAL study, have no history of cancer, heart disease, or stroke, and aren't on bone-active medications currently or within the past year (or bisphosphonates within 2 years).Check my eligibility

What is being tested?

This trial tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce the risk of serious diseases like cancer and heart disease in healthy individuals.See study design

What are the potential side effects?

Potential side effects may include mild digestive discomfort from fish oil and possible high calcium levels or kidney stones from vitamin D3; however, these supplements are generally well-tolerated.

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 ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Bone Turnover Beta Crosslaps

Bone Turnover P1NP

Change in Bone Density

Secondary outcome measures

Change in Bone Structure

Other outcome measures

Body Composition

VITAL Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Vitamin D + fish oilActive Control2 Interventions

Daily vitamin D (2,000 IU/d) and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)

Group II: Vitamin D placebo + fish oilActive Control2 Interventions

Daily vitamin D placebo and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)

Group III: Vitamin D + fish oil placeboActive Control2 Interventions

Daily vitamin D (2,000 IU/d) and daily fish oil placebo

Group IV: Vitamin D placebo + fish oil placeboPlacebo Group2 Interventions

Daily vitamin D placebo and daily fish oil placebo

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

485 Previous Clinical Trials

1,086,129 Total Patients Enrolled

37 Trials studying Osteoporosis

40,420 Patients Enrolled for Osteoporosis

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,177 Total Patients Enrolled

8 Trials studying Osteoporosis

63,894 Patients Enrolled for Osteoporosis

Meryl S LeBoff, M.D.Principal InvestigatorBrigham and Women's Hospital

2 Previous Clinical Trials

51,742 Total Patients Enrolled

Media Library

Vitamin D3 (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT01747447 — N/A

Osteoporosis Research Study Groups: Vitamin D + fish oil, Vitamin D placebo + fish oil, Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo

Osteoporosis Clinical Trial 2023: Vitamin D3 Highlights & Side Effects. Trial Name: NCT01747447 — N/A

Vitamin D3 (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01747447 — N/A

Frequently Asked Questions

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

Can you provide further insight into the experiments that have been conducted regarding Vitamin D and fish oil?

"Currently, 18 different clinical trials are researching the effects of Vitamin d and fish oil. Out of those studies, 4 have progressed to Phase 3. These investigations happen in 35 distinct centres across Boston, Massachusetts alone."

Answered by AI

Has this investigation been done before?

"Since its initial trial sponsored by Abbott in 2005 involving 15480 participants, Vitamin d + fish oil has undergone extensive clinical investigation. Since then it has earned Phase 4 drug approval and is currently being studied at 18 different sites located across 11 nations."

Answered by AI

What is the maximum capacity for participants in this experiment?

"As of November 8th 2022, recruitment for this trial has concluded. Initially posted on August 1st 2012, the study is no longer considering applicants. However, there are currently 22 active clinical trials recruiting participants related to bone health and 18 studies searching for Vitamin d + fish oil volunteers."

Answered by AI

Are there still patient positions available for this clinical investigation?

"This research has concluded its patient recruitment effort; the trial was first made available on August 1st 2012 and updated for the final time on November 8th 2022. For those interested in other studies, there are 22 investigations into bone health currently recruiting and 18 trials examining Vitamin d + fish oil that have open enrolment."

Answered by AI

Recent research and studies

The Journal of Clinical Endocrinology & MetabolismJournal

Vitamin D and Omega-3 Trial (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population

LeBoff, Meryl S, Elle M Murata, Nancy R Cook, Peggy Cawthon, Sharon H Chou, Gregory Kotler, Vadim Bubes, Julie E Buring, and JoAnn E Manson. 2020. “Vitamin D and Omega-3 Trial (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/clinem/dgaa311.

Journal of Bone and Mineral ResearchJournal

Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the Vitamin D and Omega‐3 Trial (VITAL)

LeBoff, Meryl S, Sharon H Chou, Elle M Murata, Catherine M Donlon, Nancy R Cook, Samia Mora, I‐Min Lee, et al.. 2020. “Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the Vitamin D and Omega‐3 Trial (VITAL)”. Journal of Bone and Mineral Research. Wiley. doi:10.1002/jbmr.3958.

Contemporary Clinical TrialsJournal

Vital-bone Health: Rationale and Design of Two Ancillary Studies Evaluating the Effects of Vitamin D And/or Omega-3 Fatty Acid Supplements on Incident Fractures and Bone Health Outcomes in the Vitamin D and Omega-3 Trial (VITAL)

LeBoff, Meryl S., Amy Y. Yue, Trisha Copeland, Nancy R. Cook, Julie E. Buring, and JoAnn E. Manson. 2015. “Vital-bone Health: Rationale and Design of Two Ancillary Studies Evaluating the Effects of Vitamin D And/or Omega-3 Fatty Acid Supplements on Incident Fractures and Bone Health Outcomes in the Vitamin D and Omega-3 Trial (VITAL)”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2015.01.007.

Contemporary Clinical TrialsJournal