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Dietary Supplement
Vitamin D3 + Omega-3 Fatty Acids for Infections
N/A
Waitlist Available
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 up to 5 years
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?
This trial is for participants already enrolled in the VITAL study (NCT 01169259), which includes U.S. men and women without a prior history of cancer, heart disease, or stroke.
What is being tested?
The study tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can reduce the risk of infections and affect hCAP18 levels in blood.
What are the potential side effects?
Potential side effects may include mild digestive discomfort from fish oil and possible high calcium levels or kidney stones from vitamin D3, though individual reactions vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: vitamin D placebo + fish oilActive Control2 Interventions
vitamin D placebo + Omacor
Group II: vitamin D + fish oilActive Control2 Interventions
vitamin D3 + Omacor
Group III: vitamin D + fish oil placeboActive Control2 Interventions
vitamin D3 + fish oil placebo
Group IV: vitamin D placebo + fish oil placeboPlacebo Group2 Interventions
vitamin D placebo + fish oil placebo
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,814,361 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: vitamin D placebo + fish oil
- Group 2: vitamin D + fish oil
- Group 3: vitamin D + fish oil placebo
- Group 4: vitamin D placebo + fish oil placebo
Awards:
This trial has 0 awards, including: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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