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

NCT01684722 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1312

Last updated 2022-06-21

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D

Vitamin D3 (cholecalciferol), 2000 IU per day.

DRUG

Omega-3 fatty acids (fish oil)

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 \[DHA\]).

DIETARY_SUPPLEMENT

Vitamin D placebo

Vitamin D3 placebo

DIETARY_SUPPLEMENT

Fish oil placebo

Fish oil placebo

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Ian H de Boer, MD, MS · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2019-11-08
Completion
2019-11-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01684722 on ClinicalTrials.gov