CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 17 enrolled
Drug / intervention
Omega-3 fatty acid ethylester 90 +2 moredrug
Likely dose
Omega-3 fatty acid ethylester 90 1gfrom record
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Search/NCT01596842
NCT01596842Phase 4Completed
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Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients

Dong-A University·interventional·Posted May 11, 2012·Updated Mar 10, 2015

In Brief

A Phase 4 clinical trial evaluating Omega-3 fatty acid ethylester 90, Olive oil, and 1 other intervention for Hemodialysis Patients and 2 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed Summary

Extra-renal sources of 1, 25-dihydroxyvitamin D can be increased to normal serum 1, 25-dihydroxyvitamin D levels in chronic kidney disease patients after administration of high dose 25-hydroxyvitamin D. The investigators observed that 1, 25-dihydroxyvitamin D concentrations were significantly increased after 3 months of omega-3 FA supplementation compared to baseline levels without 25-hydroxyvitamin D administration in dialysis patients. In this study, the investigators hypothesized that omega-3 FA and 25-hydroxyvitamin D supplementations may increase 1, 25-dihydroxyvitamin D concentrations much more compared to 25-hydroxyvitamin D supplementation only in hemodialysis patients with insufficient or deficient 25-hydroxyvitamin D levels.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemodialysis Patients, Vitamin D Insufficiency, Vitamin D Deficiency
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 11, 2012
Enrollment StartMay 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 14.1 years ago

Interventions

Omega-3 fatty acid ethylester 90drug

Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks

Olive oilother

Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks

cholecalciferolother

if baseline 25-hydroxyvitamin D levels are \< 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks