Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease
NCT ID: NCT01684722
Last Updated: 2022-06-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1312 participants
INTERVENTIONAL
2010-07-31
2019-11-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Vitamin D and Omega-3 Supplementation for Preventing Diabetes
NCT01633177
Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives
NCT02757872
VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL)
NCT01747447
Vitamin D and Omega-3 Trial (VITAL)
NCT01169259
Impact of Vitamin D Supplementation on Cardiac Structure and Function
NCT01630213
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Vitamin D and omega-3 fatty acids are promising interventions for DKD prevention and treatment, based on results of animal-experimental models and early human studies. Because these interventions are relatively safe, inexpensive, and widely available, they may offer opportunity to substantially reduce the burden of DKD in large populations. This VITAL ancillary study will test whether vitamin D3 and/or omega-3 fatty acids prevent progression of albuminuria and loss of glomerular filtration rate, two complementary manifestations of DKD, over 3 years of treatment.
In VITAL, 20,000 participants will be randomly assigned in a 2x2 factorial design to vitamin D3 (cholecalciferol) 2000 IU daily versus placebo, and to eicosapentaenoic acid 465 mg plus docosahexaenoic acid 375 mg daily versus placebo, and followed for a mean of 5 years to assess effects on cardiovascular disease and cancer events. This ancillary study will identify and recruit a sub-cohort of VITAL participants with diabetes at baseline and ascertain effects of study interventions on albuminuria and glomerular filtration rate in this group. First morning voids will be collected at baseline and year 3 for measurement of urine albumin-creatinine ratio. Blood samples will be collected simultaneously for measurement of estimated glomerular filtration rate (using serum creatinine and cystatin C) and other relevant biomarkers. This VITAL ancillary study is designed to determine whether vitamin D3 and/or omega-3 fatty acids have causal and clinically relevant effects on the development and progression of DKD.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vitamin D + fish oil
Vitamin D and omega-3 fatty acids (fish oil)
Vitamin D
Vitamin D3 (cholecalciferol), 2000 IU per day.
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 \[DHA\]).
Vitamin D + fish oil placebo
Vitamin D and fish oil placebo
Vitamin D
Vitamin D3 (cholecalciferol), 2000 IU per day.
Fish oil placebo
Fish oil placebo
Vitamin D placebo + fish oil
Vitamin D placebo and omega-3 fatty acids (fish oil)
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 \[DHA\]).
Vitamin D placebo
Vitamin D3 placebo
Vitamin D placebo + fish oil placebo
Vitamin D placebo and fish oil placebo
Vitamin D placebo
Vitamin D3 placebo
Fish oil placebo
Fish oil placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vitamin D
Vitamin D3 (cholecalciferol), 2000 IU per day.
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 \[DHA\]).
Vitamin D placebo
Vitamin D3 placebo
Fish oil placebo
Fish oil placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* Diabetes only during pregnancy
* Known cause of kidney disease other than diabetes
* History of kidney transplantation
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brigham and Women's Hospital
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Washington
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ian deBoer
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ian H de Boer, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brigham Women's Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Limonte 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.
de 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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
Access external resources that provide additional context or updates about the study.
Vitamin D and Omega-3 Trial study website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
39113
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.