CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,232 enrolled
Drug / intervention
Omega-3 Fatty acids +3 moredrug
Likely dose
Omega-3 Fatty acids 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.

Search/NCT02757872
NCT02757872Phase 3Completed

Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives

Albert Einstein College of Medicine·interventional·Posted May 2, 2016·Updated May 31, 2024

In Brief

A Phase 3 clinical trial evaluating Vitamin D3, Omega-3 Fatty acids, and 2 other interventions for Hypertension and Kidney Diseases. Completed, enrolled 2,232 participants across 1 site.

Detailed Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT01169259) is an ongoing randomized clinical trial in 25,875 US men and women investigating whether taking dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor (R) fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The VITAL Kidney Function in Hypertension ancillary study will evaluate the effects of vitamin D or omega-3 fatty acids on kidney function among participants with baseline hypertension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2, 2016
Enrollment StartApr 1, 2016
Primary CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 10.2 years ago

Interventions

Vitamin D3dietary

Vitamin D3 (cholecalciferol), 2000 IU per day

Omega-3 Fatty acidsdrug

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 D3 placebodietary

Vitamin D3 placebo

Fish oil placebodietary

Fish oil placebo