Effect of Omega-3 Fatty Acid on Vitamin D Activation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-12-31

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.

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Detailed Description

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Conditions

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Hemodialysis Patients Vitamin D Insufficiency Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Omega-3 fatty acid

Group Type ACTIVE_COMPARATOR

Omega-3 fatty acid ethylester 90

Intervention Type DRUG

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

cholecalciferol

Intervention Type OTHER

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

Olive oil

Group Type PLACEBO_COMPARATOR

Olive oil

Intervention Type OTHER

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

cholecalciferol

Intervention Type OTHER

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

Interventions

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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

Intervention Type DRUG

Olive oil

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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Omacor®

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No