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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
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 moreTrial 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
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,628 Previous Clinical Trials
11,448,765 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,791,997 Total Patients Enrolled
Howard D. Sesso, ScD, MPHPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
213 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have a history of high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Vitamin D + fish oil
- Group 2: Vitamin D placebo + fish oil placebo
- Group 3: Vitamin D placebo + fish oil
- Group 4: Vitamin D + fish oil placebo
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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