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Omega-3 Fatty Acid

Vitamin D + Omega-3 for Preventing Major Diseases

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

All participants from the VITAL parent study (NCT01169259) were enrolled in this ancillary study

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) 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 who were part of the VITAL parent study, looking at whether daily supplements of vitamin D3 or omega-3 fatty acids can prevent cancer, heart disease, and stroke in those without a history of these conditions.Check my eligibility

What is being tested?

The study tests if taking vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram) daily reduces the risk of broken bones. It also explores if vitamin D's effect on bone fractures is influenced by genetic factors related to vitamin D levels.See study design

What are the potential side effects?

Potential side effects from Vitamin D3 may include high calcium levels, kidney stones, or digestive issues. Omega-3s might cause fishy burps, bleeding risks, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Secondary outcome measures

Fracture

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 / 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

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

483 Previous Clinical Trials

1,061,069 Total Patients Enrolled

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

2 Previous Clinical Trials

26,642 Total Patients Enrolled

Media Library

Fish Oil (Omega-3 Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT01704859 — N/A

Broken Bones Research Study Groups: Vitamin D placebo + fish oil placebo, Vitamin D + fish oil placebo, Vitamin D placebo + fish oil, Vitamin D + fish oil

Broken Bones Clinical Trial 2023: Fish Oil Highlights & Side Effects. Trial Name: NCT01704859 — N/A

Fish Oil (Omega-3 Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01704859 — N/A

Frequently Asked Questions

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

What have been the notable outcomes from prior experiments on Vitamin D and fish oil?

"Currently, 17 investigations are being conducted in regards to the combination of Vitamin d and fish oil with 4 trials already at Phase 3. Out of these many studies, 34 different sites have been selected for research purposes; a significant number of them located within Boston, Massachusetts."

Answered by AI

Is this a pioneering experiment in its field?

"Presently, 17 studies related to the combination of Vitamin d and fish oil are ongoing in 11 nations across 7 cities. This research began with Abbott's 2005 Phase 4 trial that included 15480 participants and has since concluded 267 investigations."

Answered by AI

Does this research endeavor still accept new participants?

"This trial is not currently seeking new patients. First posted on June 1st 2018 and most recently updated to include additional information on July 14th 2022, the study has finished patient recruitment. However, there are 347 clinical trials related to fractures & bones as well as 17 studies exploring Vitamin d + fish oil that have openings at this time."

Answered by AI

How many participants are being recruited to take part in this trial?

"Unfortunately, this clinical trial is no longer open for enrollment. It was first advertised on June 1st 2018 and last edited July 14th 2022. If you're still looking to join a medical study, there are currently 347 trials related to fractures and bone health as well as 17 studies exploring the benefits of Vitamin d + Fish Oil that are presently recruiting participants."

Answered by AI

Recent research and studies

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.

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.

Journal of Bone and Mineral ResearchJournal