NCT01596842

Effect of Omega-3 Fatty Acid on Vitamin D Activation

Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Dong-A University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis Patients
• Vitamin D Insufficiency
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	Omega-3 fatty acid ethylester 90	Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
OTHER	Olive oil	Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
OTHER	cholecalciferol	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

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-05-11
• Last updated: 2015-03-10
• Results posted: 2015-03-10

Locations

1 site across 1 country: South Korea