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Fatty Acid

Vitamin D + Omega-3 for Diabetes Prevention

N/A
Waitlist Available
Led By Yiqing Song, MD, ScD
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
Participants in VITAL (NCT01169259) who have no history of diabetes mellitus at baseline are eligible to participate in this ancillary study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing whether taking daily supplements of vitamin D3 or omega-3 fatty acids 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 men and women already participating in the VITAL study without a history of diabetes. It aims to see if taking daily supplements of vitamin D3 or omega-3 fatty acids can prevent type 2 diabetes in those who don't have it.
What is being tested?
The trial tests whether daily doses of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can lower the risk of developing type 2 diabetes among participants with no prior instances of heart disease, cancer, or stroke.
What are the potential side effects?
Potential side effects from Vitamin D supplementation may include nausea, constipation, and weakness. Omega-3s might cause a fishy aftertaste, upset stomach, and bleeding risks.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Vitamin D and Omega-3Active Control2 Interventions
Group II: Vitamin D and Omega-3 placeboActive Control2 Interventions
Group III: Vitamin D placebo and Omega-3Active Control2 Interventions
Group IV: Vitamin D placebo and Omega-3 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 Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,311,578 Total Patients Enrolled
Yiqing Song, MD, ScDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Fish Oil Placebo (Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT01633177 — N/A
Type 2 Diabetes Research Study Groups: Vitamin D and Omega-3, Vitamin D and Omega-3 placebo, Vitamin D placebo and Omega-3, Vitamin D placebo and Omega-3 placebo
Type 2 Diabetes Clinical Trial 2023: Fish Oil Placebo Highlights & Side Effects. Trial Name: NCT01633177 — N/A
Fish Oil Placebo (Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01633177 — N/A
~1697 spots leftby Dec 2025
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