Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease
VITAL-DKD
2 other identifiers
interventional
1,312
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Jul 2010
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 6, 2012
CompletedFirst Posted
Study publicly available on registry
September 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2019
CompletedResults Posted
Study results publicly available
June 26, 2020
CompletedJune 21, 2022
June 1, 2022
9.4 years
September 6, 2012
May 14, 2020
June 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Estimated Glomerular Filtration Rate
GFR estimated from serum creatinine and cystatin C
baseline to 5 years
Secondary Outcomes (4)
Change in Urine Albumin Excretion
baseline to 5 years
Change in C-reactive Protein
baseline to 5 years
Change in Interleukin-6
baseline to 5 years
Change in NT-proBNP
baseline to 5 years
Study Arms (4)
Vitamin D + fish oil
ACTIVE COMPARATORVitamin D and omega-3 fatty acids (fish oil)
Vitamin D + fish oil placebo
ACTIVE COMPARATORVitamin D and fish oil placebo
Vitamin D placebo + fish oil
ACTIVE COMPARATORVitamin D placebo and omega-3 fatty acids (fish oil)
Vitamin D placebo + fish oil placebo
PLACEBO COMPARATORVitamin D placebo and fish oil placebo
Interventions
Vitamin D3 (cholecalciferol), 2000 IU per day.
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 placebo
Fish oil placebo
Eligibility Criteria
You may not qualify if:
- Type 1 diabetes
- Diabetes only during pregnancy
- Known cause of kidney disease other than diabetes
- History of kidney transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (3)
Best CM, Zelnick LR, Thummel KE, Hsu S, Limonte C, Thadhani R, Sesso HD, Manson JE, Buring JE, Mora S, Lee IM, Cook NR, Friedenberg G, Luttmann-Gibson H, de Boer IH, Hoofnagle AN. Serum Vitamin D: Correlates of Baseline Concentration and Response to Supplementation in VITAL-DKD. J Clin Endocrinol Metab. 2022 Jan 18;107(2):525-537. doi: 10.1210/clinem/dgab693.
PMID: 34543425DERIVEDLimonte CP, Zelnick LR, Ruzinski J, Hoofnagle AN, Thadhani R, Melamed ML, Lee IM, Buring JE, Sesso HD, Manson JE, de Boer IH. Effects of long-term vitamin D and n-3 fatty acid supplementation on inflammatory and cardiac biomarkers in patients with type 2 diabetes: secondary analyses from a randomised controlled trial. Diabetologia. 2021 Feb;64(2):437-447. doi: 10.1007/s00125-020-05300-7. Epub 2020 Oct 24.
PMID: 33098434DERIVEDde Boer IH, Zelnick LR, Ruzinski J, Friedenberg G, Duszlak J, Bubes VY, Hoofnagle AN, Thadhani R, Glynn RJ, Buring JE, Sesso HD, Manson JE. Effect of Vitamin D and Omega-3 Fatty Acid Supplementation on Kidney Function in Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1899-1909. doi: 10.1001/jama.2019.17380.
PMID: 31703120DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ian de Boer, MD, MS
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Ian H de Boer, MD, MS
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 6, 2012
First Posted
September 13, 2012
Study Start
July 1, 2010
Primary Completion
November 8, 2019
Study Completion
November 8, 2019
Last Updated
June 21, 2022
Results First Posted
June 26, 2020
Record last verified: 2022-06