CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,312 enrolled
Drug / intervention
Omega-3 fatty acids (fish oil) +3 moredrug
Likely dose
Omega-3 fatty acids (fish oil) 840 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT01684722N/ACompleted
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Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease

University of Washington·interventional·Posted Sep 13, 2012·Updated Jun 21, 2022

In Brief

A clinical study evaluating Vitamin D, Omega-3 fatty acids (fish oil), and 2 other interventions for Diabetes. Completed, enrolled 1,312 participants across 1 site.

Detailed Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of 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. This ancillary study is being conducted among participants in VITAL with a history of diabetes and will examine whether vitamin D or fish oil prevents the development and progression of diabetic kidney disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
CollaboratorsBrigham and Women's Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2012
Enrollment StartJul 1, 2010
Primary CompletionNov 8, 2019
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 13.8 years ago

Interventions

Vitamin Ddietary

Vitamin D3 (cholecalciferol), 2000 IU per day.

Omega-3 fatty acids (fish oil)drug

Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).

Vitamin D placebodietary

Vitamin D3 placebo

Fish oil placebodietary

Fish oil placebo