N/A
Completed N=1,312
Vitamin D and Omega-3 Trial to Prevent and Treat Diabetic Kidney Disease
Source: ClinicalTrials.gov NCT01684722 ↗Enrolled (actual)
1,312
Serious AEs
14.7%
Results posted
Jun 2020
Primary outcomePrimary: Change in Estimated Glomerular Filtration Rate — -12.3; -13.1; -12.2; -13.1 mL/min/1.73m2 — p=0.25
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Estimated Glomerular Filtration Rate |
-12.3; -13.1; -12.2; -13.1 | 0.25 |
| SECONDARY Change in Urine Albumin Excretion |
2.97; 3.02; 2.94; 3.05 | 0.90 |
| SECONDARY Change in C-reactive Protein |
0.93; 1.03; 0.90; 1.05 | — |
| SECONDARY Change in Interleukin-6 |
1.04; 1.09; 1.10; 1.02 | — |
| SECONDARY Change in NT-proBNP |
1.72; 1.38; 1.56; 1.54 | — |
Eligibility Criteria
Inclusion Criteria: Participants in VITAL (NCT 01169259) with a self-reported physician diagnosis of diabetes are eligible to participate in this ancillary study.
Exclusion Criteria
- Type 1 diabetes
- Diabetes only during pregnancy
- Known cause of kidney disease other than diabetes
- History of kidney transplantation
Data sourced from ClinicalTrials.gov (NCT01684722). 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. Informational only — not medical advice.