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Omega-3 Fatty Acids

Omega-3 + Vitamin D for High Blood Pressure

N/A
Waitlist Available
Led By Howard D. Sesso, ScD, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
All Individual Drugs Already Approved

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in blood pressure
Changes in 25-hydroxy-vitamin D levels
Changes in biomarkers related to blood pressure
+2 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,852,391 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,772,018 Total Patients Enrolled
Howard D. Sesso, ScD, MPHPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
213 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
~0 spots leftby Jan 2025
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