DiabetesVITAL-DKDNCT01684722

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

A study testing Vitamin D and Omega-3 fatty acids (fish oil) in people with Diabetes, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Diabetes
What is being tested?: Vitamin D and Omega-3 fatty acids (fish oil)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,312 participants
Where: 1 siteUnited States
Study dates: Jul 2010to 8 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Type 1 diabetes
Diabetes only during pregnancy
Known cause of kidney disease other than diabetes
History of kidney transplantation

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham Women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

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.

Read the detailed description

This ancillary study to the VITamin D and OmegA-3 TriaL (VITAL) will test whether vitamin D3, omega-3 fatty acids, or both prevent the development and progression of diabetic kidney disease (DKD). Persons with diabetes are at high risk of kidney disease. In 2005-2008, the prevalence of DKD among people with type 2 diabetes in the United States was 34.5%. Moreover, from 1988-1994 to 2005-2008, the prevalence of DKD in the United States grew 34% to 6.9 million people. DKD is both the leading cause of end stage renal disease in the developed world and a potent amplifier of cardiovascular disease risk.

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: Diabetes
Being tested: Vitamin D, Omega-3 fatty acids (fish oil), Vitamin D placebo, Fish oil placebo
Keywords: vitamin D3, omega-3 fatty acids, fish oil, diabetes, kidney disease, albuminuria, urine albumin excretion, glomerular filtration rate, diabetic kidney disease
Medical subject headings: Diabetes Mellitus, Kidney Diseases, Albuminuria, Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin DDietary supplement
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 supplement
Vitamin D3 placebo
Fish oil placeboDietary supplement
Fish oil placebo

Study groups in NCT01684722
Study group	Role	What they receive
Vitamin D + fish oil	Active comparator	Vitamin D and omega-3 fatty acids (fish oil) Receives: Dietary Supplement: Vitamin D; Drug: Omega-3 fatty acids (fish oil)
Vitamin D + fish oil placebo	Active comparator	Vitamin D and fish oil placebo Receives: Dietary Supplement: Vitamin D; Dietary Supplement: Fish oil placebo
Vitamin D placebo + fish oil	Active comparator	Vitamin D placebo and omega-3 fatty acids (fish oil) Receives: Drug: Omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D placebo
Vitamin D placebo + fish oil placebo	Placebo comparator	Vitamin D placebo and fish oil placebo Receives: Dietary Supplement: Vitamin D placebo; Dietary Supplement: Fish oil placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Estimated Glomerular Filtration Rate
GFR estimated from serum creatinine and cystatin C
Measured: baseline to 5 years

Secondary outcomes (4)

Change in Urine Albumin Excretion
Change in urine albumin-creatinine ratio.
Measured: baseline to 5 years
Change in C-reactive Protein
Changes in serum concentrations in CRP
Measured: baseline to 5 years
Change in Interleukin-6
Changes in serum concentrations in IL-6
Measured: baseline to 5 years
Change in NT-proBNP
Changes in serum concentrations in NT-proBNP
Measured: baseline to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 20108 Nov 2019

First posted13 Sep 2012 (estimated)
Study startJul 2010
Primary completion8 Nov 2019
Study completion8 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01684722
Sponsor's protocol ID: 39113
Other IDs: R01DK088762
Acronym: VITAL-DKD
Status last verified: Jun 2022
First submitted: 6 Sep 2012
Last updated: 21 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 34543425
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.
PubMed 33098434
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.
PubMed 31703120

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease
ClinicalTrials.gov ID: NCT01684722
Acronym / sponsor ID: VITAL-DKD / 39113
Conditions: Diabetes
Keywords: vitamin D3, omega-3 fatty acids, fish oil, diabetes, kidney disease, albuminuria, urine albumin excretion, glomerular filtration rate
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,312 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Brigham and Women's Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Jul 2010 (actual)
Primary completion: 8 Nov 2019 (actual)
Study completion: 8 Nov 2019 (actual)
First posted: 13 Sep 2012 (estimated)
Results: Posted 26 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Vitamin D + fish oil	Active comparator	Dietary Supplement: Vitamin D, Drug: Omega-3 fatty acids (fish oil)Vitamin D and omega-3 fatty acids (fish oil)
Vitamin D + fish oil placebo	Active comparator	Dietary Supplement: Vitamin D, Dietary Supplement: Fish oil placeboVitamin D and fish oil placebo
Vitamin D placebo + fish oil	Active comparator	Drug: Omega-3 fatty acids (fish oil), Dietary Supplement: Vitamin D placeboVitamin D placebo and omega-3 fatty acids (fish oil)
Vitamin D placebo + fish oil placebo	Placebo comparator	Dietary Supplement: Vitamin D placebo, Dietary Supplement: Fish oil placeboVitamin D placebo and fish oil placebo

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (4 listed)

Type 1 diabetes
Diabetes only during pregnancy
Known cause of kidney disease other than diabetes
History of kidney transplantation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin DVitamin D3 (cholecalciferol), 2000 IU per day.	Dietary supplement	Vitamin D + fish oil, Vitamin D + fish oil placebo
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]).	Drug	Vitamin D + fish oil, Vitamin D placebo + fish oil
Vitamin D placeboVitamin D3 placebo	Dietary supplement	Vitamin D placebo + fish oil, Vitamin D placebo + fish oil placebo
Fish oil placeboFish oil placebo	Dietary supplement	Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo

Primary outcome

Change in Estimated Glomerular Filtration Rate
Time frame: baseline to 5 years
GFR estimated from serum creatinine and cystatin C

4 secondary outcomes

Change in Urine Albumin Excretion
Time frame: baseline to 5 years
Change in C-reactive Protein
Time frame: baseline to 5 years
Change in Interleukin-6
Time frame: baseline to 5 years
Change in NT-proBNP
Time frame: baseline to 5 years

Results and safety

Results posted to the registry on 26 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamin D + Fish Oil Placebo	333	236
Vitamin D Placebo + Fish Oil	289	212
Vitamin D Placebo + Fish Oil Placebo	320	226
Vitamin D + Fish Oil	370	260

Primary outcome: Change in Estimated Glomerular Filtration Rate

Time frame: baseline to 5 years. Mean (95% Confidence Interval). Unit: mL/min/1.73m2

Measure	Vitamin D n = 703	Vitamin D Placebo n = 609	Fish Oil n = 659	Fish Oil Placebo n = 653
Value	-12.3 (-13.4 to -11.2)	-13.1 (-14.2 to -11.9)	-12.2 (-13.3 to -11.1)	-13.1 (-14.2 to -12.0)

Vitamin D vs Vitamin D Placebo: Mean Difference (Final Values): 0.9 (95% CI -0.7 to 2.5), p = 0.25, Mixed Models Analysis
Fish Oil vs Fish Oil Placebo: Mean Difference (Final Values): 0.9 (95% CI -0.7 to 2.6), p = 0.27, Mixed Models Analysis

Population analysed: Outcomes analyzed according to factorial assignments, without evidence of treatment interaction.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to five years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vitamin D + Fish Oil Placebo	45 of 333 (13.5%)	134 of 333 (40.2%)	19 of 333
Vitamin D Placebo + Fish Oil	59 of 289 (20.4%)	135 of 289 (46.7%)	21 of 289
Vitamin D Placebo + Fish Oil Placebo	45 of 320 (14.1%)	133 of 320 (41.6%)	19 of 320
Vitamin D + Fish Oil	44 of 370 (11.9%)	136 of 370 (36.8%)	21 of 370

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34543425Best 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.
Derived from this study: PubMed 33098434Limonte 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.
Derived from this study: PubMed 31703120de 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.
Vitamin D and Omega-3 Trial study websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ian H de Boer, MD, MS principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D and Omega-3 fatty acids (fish oil) in people with Diabetes, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Estimated Glomerular Filtration Rate (time frame: baseline to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01684722, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.