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Omega-3 Fatty Acids

Vitamin D + Omega-3 for Osteoporosis

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

None of the following: allergy to soy or fish, hypercalcemia, renal failure or dialysis, severe liver disease, hypo- or hyperparathyroidism, sarcoidosis or other granulomatous diseases, or any other serious illnesses

No history of cardiovascular disease or cancer (excluding non-melanoma skin cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial found that vitamin K status was not associated with bone loss or fractures in postmenopausal women.

Who is the study for?

This trial is for men over 50 and women over 55 without cardiovascular disease or cancer, except non-melanoma skin cancer. Participants should not consume more than 1200 mg of calcium or take fish oil supplements during the trial. They must also avoid high doses of vitamin D (over 800 IU). People with severe liver disease, kidney failure, certain hormonal disorders, or other serious illnesses cannot join.Check my eligibility

What is being tested?

The VITAL study examines how Vitamin D3 and Omega-3 fatty acids (fish oil) affect bone health in older adults. It's testing whether these supplements can help prevent osteoporosis and broken bones by improving calcium deposition in bones.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort from fish oil and too much calcium in the blood from Vitamin D3. However, specific side effects will depend on individual reactions to the supplements.

Eligibility Criteria

Inclusion Criteria

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

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I do not have allergies to soy or fish, severe kidney, liver, or parathyroid issues, sarcoidosis, or other serious illnesses.

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I have no history of heart disease or cancer, except for non-melanoma skin cancer.

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I am a man over 50 or a woman over 55.

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

Number of Fractures

Secondary outcome measures

Change in Areal Bone Density

Change in Bone Strength

Change in Cortical Thickness

+3 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Vitamin D + fish oil placeboActive Control2 Interventions

Group II: Vitamin D placebo + fish oilActive Control2 Interventions

Group III: Vitamin D + fish oilActive Control2 Interventions

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,609 Previous Clinical Trials

11,444,456 Total Patients Enrolled

8 Trials studying Osteoporosis

63,894 Patients Enrolled for Osteoporosis

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

483 Previous Clinical Trials

1,061,069 Total Patients Enrolled

37 Trials studying Osteoporosis

40,420 Patients Enrolled for Osteoporosis

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

2 Previous Clinical Trials

26,642 Total Patients Enrolled

Media Library

Omega-3 fatty acids (fish oil) (Omega-3 Fatty Acids) Clinical Trial Eligibility Overview. Trial Name: NCT04573946 — N/A

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

Osteoporosis Clinical Trial 2023: Omega-3 fatty acids (fish oil) Highlights & Side Effects. Trial Name: NCT04573946 — N/A

Omega-3 fatty acids (fish oil) (Omega-3 Fatty Acids) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04573946 — N/A

Frequently Asked Questions

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

Have there been any prior experiments that looked at the synergistic effects of Vitamin D and fish oil?

"Presently, 18 clinical trials are actively exploring the utility of Vitamin d and fish oil with 4 studies in their final phase. Concentrated in Boston, Massachusetts but operating throughout 35 different sites globally, these research projects seek to understand this combination's potential."

Answered by AI

How many subjects are being recruited for this research endeavor?

"As of 14th July 2022, this trial has ceased recruitment. Its original posting was on 1st July 2019. Currently, 358 clinical trials are actively searching for participants with bone mineral density and 18 studies need more volunteers to test the effects of Vitamin d + fish oil combination therapies."

Answered by AI

Is this the inaugural study of its kind?

"Vitamin d and fish oil have been under clinical scrutiny since 2005, when Abbott sponsored the first trial (involving 15480 patients). After this initial study, Vitamin D + fishoil went through Phase 4 drug approval. At present, 18 trials are running concurrently in 11 nations across 7 cities."

Answered by AI

Are there any remaining vacancies for individuals in this clinical trial?

"Clinicaltrials.gov confirms that this medical study, originally posted on July 1st 2019, is not currently recruiting patients. However, other research projects are actively looking for volunteers and there are 376 different clinical trials with open recruitment presently."

Answered by AI

Recent research and studies

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.

Osteoporosis InternationalJournal

Vitamin D and Omega-3 Trial (VITAL) Bone Health Ancillary Study: Clinical Factors Associated with Trabecular Bone Score in Women and Men

Goldman, A. L., C. M. Donlon, N. R. Cook, J. E. Manson, J. E. Buring, T. Copeland, C. Y. Yu, and M. S. LeBoff. 2018. “Vitamin D and Omega-3 Trial (VITAL) Bone Health Ancillary Study: Clinical Factors Associated with Trabecular Bone Score in Women and Men”. Osteoporosis International. Springer Science and Business Media LLC. doi:10.1007/s00198-018-4633-3.

Contemporary Clinical TrialsJournal

Baseline Characteristics of Participants in the Vitamin D and Omega-3 Trial (VITAL): Effects on Bone Structure and Architecture

Donlon, Catherine M., Meryl S. LeBoff, Sharon H. Chou, Nancy R. Cook, Trisha Copeland, Julie E. Buring, Vadim Bubes, Gregory Kotler, and JoAnn E. Manson. 2018. “Baseline Characteristics of Participants in the Vitamin D and Omega-3 Trial (VITAL): Effects on Bone Structure and Architecture”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2018.02.003.

Contemporary Clinical TrialsJournal