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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01596842
Other study ID # DAU-12-073
Secondary ID
Status Completed
Phase Phase 4
First received May 8, 2012
Last updated March 8, 2015
Start date May 2012
Est. completion date December 2012

Study information

Verified date March 2015
Source Dong-A University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Intervention

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
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

Locations

Country Name City State
Korea, Republic of Won Suk An Busan

Sponsors (1)

Lead Sponsor Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 25-hydroxyvitamin D Levels at 12 Weeks 12 weeks No
Secondary Hemoglobin Levels at 12 Weeks 12 weeks No
Secondary Changes of Calcium Levels 4 weeks, 8 weeks and 12 weeks No
Secondary Change of Intact Parathyroid Hormone 12 weeks No
Secondary Change of Fetuin-A Levels 12 weeks No
Secondary Change of FGF-23 Levels 12 weeks No
Secondary Changes of Phosphorous Levels 4 weeks, 8 weeks and 12 weeks No
Secondary Changes of Erythropoietin Doses 4 weeks, 8 weeks and 12 weeks No
Secondary Changes of Phosphate Binder Doses 4 weeks, 8 weeks and 12 weeks No
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