HypertensionPhase 3NCT02757872
Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives
A Phase 3 study testing Vitamin D3 and Omega-3 Fatty acids in people with Hypertension and Kidney Diseases, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Hypertension, Kidney Diseases
- What is being tested?
- Vitamin D3 and Omega-3 Fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,232 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 31 Mar 2022
- Phase
- Phase 3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants in VITAL (NCT01169259) with a self-reported physician diagnosis of hypertension are eligible to participate in this ancillary study
Who cannot join
- Diagnosis of diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
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 kidney disease in participants with hypertension. Persons with hypertension are at high risk of kidney disease.
Vitamin D and omega-3 fatty acids are promising interventions for kidney disease 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 kidney disease in large populations. This VITAL ancillary study will test whether vitamin D3 and/or omega-3 fatty acids prevent loss of glomerular filtration rate, over 4 years of therapy.
In VITAL, 25,875 participants have been 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 hypertension at baseline and ascertain effects of study interventions on glomerular filtration rate in this group. Blood samples will be collected at year 4 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 kidney disease in hypertensives.
- Conditions
- Hypertension, Kidney Diseases
- Being tested
- Vitamin D3, Omega-3 Fatty acids, Vitamin D3 placebo, Fish oil placebo
- Keywords
- Hypertension, Kidney Diseases, Vitamin D, Omega 3 fatty acids
- Medical subject headings
- Hypertension, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Vitamin D3 (cholecalciferol), 2000 IU per day
Omega-3 Fatty acidsDrug
Also called 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 D3 placeboDietary supplement
Vitamin D3 placebo
Fish oil placeboDietary supplement
Fish oil placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D and Omega-3 Fatty acids | Active comparator | Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule 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]). Receives: Dietary Supplement: Vitamin D3; Drug: Omega-3 Fatty acids |
| Vitamin D and Omega-3 Fatty acid Placebo | Active comparator | Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day.
Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo) Receives: Dietary Supplement: Vitamin D3; Dietary Supplement: Fish oil placebo |
| Vitamin D Placebo and Omega-3 Fatty acids | Active comparator | 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. One capsule per day Vitamin D3 placebo Receives: Drug: Omega-3 Fatty acids; Dietary Supplement: Vitamin D3 placebo |
| Vitamin D Placebo and Omega-3 Fatty acid Placebo | Placebo comparator | Dietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo
Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day Receives: Dietary Supplement: Vitamin D3 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
Serum creatinine and cystatin C measurement pre-randomization and year 4
Measured: Baseline and 4 years
Secondary outcomes (1)
Confirmation of Microalbuminuria
Number of participants with positive Microalbuminuria was reported. Participants were defined as having positive microalbuminuria if their lab results were >30 mg/g Creatinine
Measured: 4 years post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startApr 2016
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
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.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Parent (VITAL; NCT01169259) study was based upon a 2x2 factorial design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Michal L Melamed, MD, MHS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757872
- Sponsor's protocol ID
- 2014-3778
- Other IDs
- R01DK102952
- Status last verified
- May 2024
- First submitted
- 28 Apr 2016
- Last updated
- 31 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives
- ClinicalTrials.gov ID
- NCT02757872
- Acronym / sponsor ID
- 2014-3778
- Conditions
- Hypertension, Kidney Diseases
- Keywords
- Hypertension, Kidney Diseases, Vitamin D, Omega 3 fatty acids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,232 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Apr 2016 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Posted 31 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 kidney disease in participants with hypertension. Persons with hypertension are at high risk of kidney disease.
Vitamin D and omega-3 fatty acids are promising interventions for kidney disease 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 kidney disease in large populations. This VITAL ancillary study will test whether vitamin D3 and/or omega-3 fatty acids prevent loss of glomerular filtration rate, over 4 years of therapy.
In VITAL, 25,875 participants have been 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 hypertension at baseline and ascertain effects of study interventions on glomerular filtration rate in this group. Blood samples will be collected at year 4 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 kidney disease in hypertensives.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Parent (VITAL; NCT01169259) study was based upon a 2x2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Vitamin D and Omega-3 Fatty acids | Active comparator | Dietary Supplement: Vitamin D3, Drug: Omega-3 Fatty acidsDietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule 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]). |
| Vitamin D and Omega-3 Fatty acid Placebo | Active comparator | Dietary Supplement: Vitamin D3, Dietary Supplement: Fish oil placeboDietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), one 2000 IU capsule per day. Dietary Supplement: Omega-3 fatty acid placebo (Fish oil placebo) |
| Vitamin D Placebo and Omega-3 Fatty acids | Active comparator | Drug: Omega-3 Fatty acids, Dietary Supplement: Vitamin D3 placeboDrug: 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. One capsule per day Vitamin D3 placebo |
| Vitamin D Placebo and Omega-3 Fatty acid Placebo | Placebo comparator | Dietary Supplement: Vitamin D3 placebo, Dietary Supplement: Fish oil placeboDietary Supplement: Vitamin D placebo. One capsule per day Vitamin D3 placebo Dietary Supplement: Omega-3 Fatty acid Placebo (Fish oil placebo). One capsule per day |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants in VITAL (NCT01169259) with a self-reported physician diagnosis of hypertension are eligible to participate in this ancillary study
Key exclusion criteria (1 listed)
- Diagnosis of diabetes mellitus
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 D3Vitamin D3 (cholecalciferol), 2000 IU per day | Dietary supplement | Vitamin D and Omega-3 Fatty acid Placebo, Vitamin D and Omega-3 Fatty acids |
| Omega-3 Fatty acidsAlso: Fish oilOmacor, 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 Placebo and Omega-3 Fatty acids, Vitamin D and Omega-3 Fatty acids |
| Vitamin D3 placeboVitamin D3 placebo | Dietary supplement | Vitamin D Placebo and Omega-3 Fatty acid Placebo, Vitamin D Placebo and Omega-3 Fatty acids |
| Fish oil placeboFish oil placebo | Dietary supplement | Vitamin D Placebo and Omega-3 Fatty acid Placebo, Vitamin D and Omega-3 Fatty acid Placebo |
Primary outcome
Change in Estimated Glomerular Filtration Rate
Time frame: Baseline and 4 years
Serum creatinine and cystatin C measurement pre-randomization and year 4
1 secondary outcome
Confirmation of Microalbuminuria
Time frame: 4 years post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michal L Melamed, MD, MHS principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 and Omega-3 Fatty acids in people with Hypertension and Kidney Diseases, run by Albert Einstein College of Medicine 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 1 inclusion and 1 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 31 May 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2024). 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 and 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2024.