Phase 3
N=2,232
Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives
Hypertension · Kidney Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02757872 ↗Enrolled (actual)
2,232
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Change in Estimated Glomerular Filtration Rate
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vitamin D3 (Dietary_supplement); Omega-3 Fatty acids (Drug); Vitamin D3 placebo (Dietary_supplement); Fish oil placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Estimated Glomerular Filtration Rate |
— | — |
| SECONDARY Confirmation of Microalbuminuria |
4; 6; 6; 6 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- Participants in VITAL (NCT01169259) with a self-reported physician diagnosis of hypertension are eligible to participate in this ancillary study
Exclusion Criteria
- Diagnosis of diabetes mellitus
Data sourced from ClinicalTrials.gov (NCT02757872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.