Go Fish: Omega-3 Fatty Acid Supplementation in Diabetes-Related Kidney Disease
Completed · Phase 3
Conditions studied: Diabetes
In brief
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.
Key facts
- Study ID
- NCT01092390
- Run by
- Johns Hopkins University
- People needed
- 31
- Starts
- 2010-03-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2012-04-30
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Johns Hopkins ProHealth, 1849 Gwynn Oak Ave — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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