Effect of Omega-3 Fatty Acid on Vitamin D Activation

Phase 4

Completed

• Conditions: Vitamin D Insufficiency; Vitamin D Deficiency; Hemodialysis Patients
• Interventions: Drug: Omega-3 fatty acid ethylester 90; Other: Olive oil; Other: cholecalciferol

• Registration Number: NCT01596842
• Lead Sponsor: Dong-A University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-11
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2015-02-20
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-08
• Last Update Submitted: 2015-03-08
• Results First Posted: 2015-03-10
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Patients who were treated with hemodialysis for at least 6 months with 25-hydroxyvitamin D < 30 ng/mL

Exclusion Criteria

• Patients with a history of active infection within 3 months,
• Patients with fish oil or omega-3 fatty acid supplementation within 3 months,
• Patients with a history of fish, gelatin, and/or omega-3 fatty acid allergies,
• Patients with a history of hospital admission within 3 months,
• Patients with a history of bleeding within 3 months,
• Patients with thrombocytopenia,
• Patients with current use of warfarin,
• Patients with an albumin level < 3.0 g/dL,
• Patients with malignancy and/or liver cirrhosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3 fatty acid	Omega-3 fatty acid ethylester 90	-
Olive oil	cholecalciferol	-
Omega-3 fatty acid	cholecalciferol	-
Olive oil	Olive oil	-

Primary Outcome Measures

Name	Time	Method
25-hydroxyvitamin D Levels at 12 Weeks	12 weeks

Secondary Outcome Measures

Name	Time	Method
Changes of Calcium Levels	4 weeks, 8 weeks and 12 weeks
Change of Intact Parathyroid Hormone	12 weeks
Change of Fetuin-A Levels	12 weeks
Hemoglobin Levels at 12 Weeks	12 weeks
Change of FGF-23 Levels	12 weeks
Changes of Phosphorous Levels	4 weeks, 8 weeks and 12 weeks
Changes of Erythropoietin Doses	4 weeks, 8 weeks and 12 weeks
Changes of Phosphate Binder Doses	4 weeks, 8 weeks and 12 weeks

Trial Locations

Locations (1)

Won Suk An; 🇰🇷 Busan, Korea, Republic of