Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/22/2018 |
| Start Date: | April 2016 |
| End Date: | March 2019 |
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) 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.
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.
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.
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.
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
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