Effect of Omega-3 Fatty Acid on Vitamin D Activation

Study Overview
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Brief Summary
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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.

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

Conditions
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Hemodialysis Patients, Vitamin D Insufficiency, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Omega-3 fatty acid ethylester 90
* Other: Olive oil
* Other: cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3 fatty acid<br> | Drug: Omega-3 fatty acid ethylester 90<br>* Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks<br>* Other names: Omacor®;Other: cholecalciferol<br>* 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<br>|
| Placebo Comparator: Olive oil<br> | Other: Olive oil<br>* Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks<br>Other: cholecalciferol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25-hydroxyvitamin D Levels at 12 Weeks |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Levels at 12 Weeks |  | 12 weeks | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ergocalciferol, Omega-3 fatty acid, vitamin D, hemodialysis