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"Go Fish"Omega-3 Fatty Acid Supplementation in Diabetic Kidney Disease
In this application the investigators describe plans for a randomized controlled cross-over trial to determine the effects of omega-3 fatty acid supplementation on urine protein excretion in 30 adults with diabetes (NIDDM) and kidney disease defined by the presence of proteinuria.
Diabetes is the most common cause of end-stage kidney disease in the United States. Half of patients with diabetes develop kidney disease. The benefits of omega-3 fatty acids have been shown in animal models of kidney injury. Mechanistic studies of omega-3 fatty acid supplements support biological plausibility: omega-3 supplements have been shown to improve vascular reactivity, lower oxidative stress, reduce inflammation, and have beneficial effects on the metabolism of eicosanoids favoring synthesis of vasodilatory prostaglandins and thromboxanes. However, in spite of overwhelming evidence for a potential benefit of dietary omega-3 fatty acids at preventing or slowing progression of kidney disease for adults with NIDDM, clinical trials providing evidence to support recommendations of supplementation are lacking. The current recommendation for omega-3 intake for adults, one gram/day of DHA+EPA, is based on evidence for cardiovascular disease risk (CVD) reduction. Whether omega-3 fatty acid prevents or slows progression of diabetic kidney disease, whether the current recommended dose is adequate to modify disease, or whether a higher dose should be recommended, needs to be determined. In this setting, we propose to conduct a randomized placebo-controlled cross-over clinical trial to determine the effects of a daily dose of omega-3 fatty acid supplementation (4.0 g/day) compared with placebo on urine protein excretion and biomarkers of kidney injury and function in adults with diabetes and proteinuria.
Age
21 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Johns Hopkins ProHealth, 1849 Gwynn Oak Ave
Baltimore, Maryland, United States
Start Date
March 1, 2010
Primary Completion Date
May 1, 2011
Completion Date
May 1, 2011
Last Updated
April 30, 2012
31
ACTUAL participants
Lovaza (fish oil)
DIETARY_SUPPLEMENT
Lead Sponsor
Johns Hopkins University
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07296484