Go Fish: Omega-3 Fatty Acid Supplementation in Diabetes-Related Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01092390
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : April 30, 2012
Information provided by (Responsible Party):
Edgar R. Miller, III, Johns Hopkins University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Lovaza (fish oil) Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Go Fish"Omega-3 Fatty Acid Supplementation in Diabetic Kidney Disease
Study Start Date : March 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lovaza
4 grams per day
Dietary Supplement: Lovaza (fish oil)
4 grams per day
Other Names:
  • fish oil (generic)
  • omega three fattay acids (generic)

Primary Outcome Measures :
  1. urine protein excretion [ Time Frame: end of 2 six week periods (crossover) ]
    Primary Specific Aim To determine the effects of omega-3 fatty acid supplementation on urine protein excretion and surrogate markers of kidney injury including: serum beta-microglobulin and cystatin C (biomarkers of GFR) and urine neutrophil gelatinase-associated lipocain (NGAL a.k.a. lipocalin-2), kidney injury molecule-1 (KIM-1), and interleukin-18 (IL-18) (biomarkers of tubular reabsorption impairment and inflammation).

Secondary Outcome Measures :
  1. Biomarkers of oxidation and inflammation [ Time Frame: end of 2 six week periods (crossover) ]
    To determine the effects of omega-3 supplements on markers of oxidations (urine isoprostanes) and inflammation (serum C-reactive protein (hsCRP), RBC fatty acids .

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Participants have a diagnosis of diabetes (either oral medication or diet controlled)
  • Have an average systolic blood pressure (SBP) <150 and diastolic blood pressure (DBP) <90 mmHg
  • Have quantified proteinuria -- urine albumin/creatinine ratio of > 17 mg/g (men) and >25 mg/g (women) (i.e. at least microalbuminuria).
  • Participants must be on stable doses of antihypertensive, hypoglycemic, and lipid lowering medications for a minimum of two months prior to randomization. Participants must agree to stay on stable doses of diabetes, antihypertensive and lipid medication for the duration of the study.

Exclusion Criteria:

  • Major exclusion criteria will be poorly controlled diabetes (Hemoglobin A1c >9%)
  • Use of insulin
  • Use of fish oil supplements or are unwilling to stop fish oil supplements one month prior to randomization and refrain from the supplements during the study
  • Stage 4 or stage 5 CKD or a screening urine protein/creatinine ratio of >2.5.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01092390

United States, Maryland
Johns Hopkins ProHealth, 1849 Gwynn Oak Ave
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Edgar R Miller, MD Johns Hopkins University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Edgar R. Miller, III, PI, Johns Hopkins University Identifier: NCT01092390     History of Changes
Other Study ID Numbers: 1R21DK080372 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by Edgar R. Miller, III, Johns Hopkins University:
randomized trial
omega three fatty acids

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases