- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02757872
Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants in VITAL (NCT 01169259) with a self-reported physician diagnosis of hypertension are eligible to participate in this ancillary study
Exclusion Criteria:
- Diagnosis of diabetes mellitus
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Vitamin D and fish oil
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]).
|
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])
Other Names:
|
Active Comparator: Vitamin D and fish oil placebo
Dietary Supplement: Vitamin D Vitamin D3 (cholecalciferol), 2000 IU per day.
Dietary Supplement: Fish oil placebo Fish oil placebo
|
Fish oil placebo
Vitamin D3 (cholecalciferol), 2000 IU per day
|
Active Comparator: Vitamin D placebo and fish oil
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 |
Vitamin D3 placebo
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])
Other Names:
|
Placebo Comparator: Vitamin D placebo and fish oil placebo
Dietary Supplement: Vitamin D placebo Vitamin D3 placebo Dietary Supplement: Fish oil placebo Fish oil placebo
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Fish oil placebo
Vitamin D3 placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in estimated glomerular filtration rate
Time Frame: 4 years
|
Serum creatinine and cystatin C measurement pre-randomization and year 4
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of Albuminuria
Time Frame: 4 years post-randomization
|
4 years post-randomization
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michal L Melamed, MD, MHS, Albert Einstein College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-3778
- R01DK102952 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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