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Omega-3 Fatty Acids

Omega-3 + Vitamin D for High Blood Pressure

N/A

Waitlist Available

Led By John P. Forman, MD

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

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 or omega-3 fatty acids reduces the risk of developing cancer, heart disease, and stroke.

Who is the study for?

The VITAL Hypertension trial is for U.S. adults without a history of high blood pressure, cancer, heart disease, or stroke who are already part of the main VITAL study. It's focused on those willing to take daily supplements and located in certain cities where home visits can be conducted.Check my eligibility

What is being tested?

This study tests if daily vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can lower the risk of developing high blood pressure. Participants are randomly assigned to receive either one of these supplements or a placebo.See study design

What are the potential side effects?

Potential side effects from omega-3s include a fishy aftertaste, upset stomach, and bleeding risks. Vitamin D at high doses may cause fatigue, weakness, dry mouth, or increased thirst and urination.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two 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

Change in blood pressure

Changes in 25-hydroxy-vitamin D levels

Changes in biomarkers related to blood pressure

+2 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Vitamin D + fish oilActive Control2 Interventions

Group II: Vitamin D placebo + fish oilActive Control2 Interventions

Group III: Vitamin D + fish oil placeboActive Control2 Interventions

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,608 Previous Clinical Trials

11,444,002 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,280,621 Total Patients Enrolled

John P. Forman, MDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Omega-3 fatty acids (fish oil) (Omega-3 Fatty Acids) Clinical Trial Eligibility Overview. Trial Name: NCT01653678 — N/A

High Blood Pressure Research Study Groups: Vitamin D + fish oil, Vitamin D placebo + fish oil placebo, Vitamin D placebo + fish oil, Vitamin D + fish oil placebo

High Blood Pressure Clinical Trial 2023: Omega-3 fatty acids (fish oil) Highlights & Side Effects. Trial Name: NCT01653678 — N/A

Omega-3 fatty acids (fish oil) (Omega-3 Fatty Acids) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01653678 — N/A

Frequently Asked Questions

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

Have any scholarly investigations been made into the combined effects of Vitamin D and fish oil?

"Presently, there are 17 ongoing trials investigating the potential of Vitamin d + fish oil. 4 of these live studies have progressed to Phase 3 in their research efforts. Although most experiments take place in Boston, Massachusetts, 34 other locations around the country are researching this combination therapy."

Answered by AI

Has a similar research effort been conducted prior to this one?

"Since 2005, Vitamin d + fish oil has been subject to research and trials. The first trial was conducted by Abbott in the same year with a sample size of 15480 participants. As a result of its success, it received Phase 4 drug approval shortly thereafter. Currently there are 17 ongoing studies related to this particular medication happening across 11 nations and 7 municipalities."

Answered by AI

How many individuals are expected to partake in this experiment?

"As of the 8th August 2022, this clinical trial is not accepting patients. It was first posted on November 1st 2011 and no longer recruits participants. For those interested in other medical studies related to hypertension, 746 trials remain available for recruitment; there are also 17 research projects involving Vitamin d + fish oil admitting test subjects."

Answered by AI

Are there any slots still available to join this research program?

"According to information on clinicaltrials.gov, this medical research is not presently recruiting participants as it has been last updated in August 2022 and was initially posted back in November 2011. Nevertheless, there are 763 other studies currently accepting patients into their trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vitamin D and Omega-3 Hypertension Trial (VITAL Hypertension)

Howard D. Sesso, ScD, MPH 2011. "Vitamin D and Omega-3 Hypertension Trial (VITAL Hypertension)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01653678.

All > Blood Pressure > Vitamin D