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Effect of Omega-3 Fatty Acid on Vitamin D Activation

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ClinicalTrials.gov Identifier: NCT01596842
Recruitment Status : Completed
First Posted : May 11, 2012
Results First Posted : March 10, 2015
Last Update Posted : March 10, 2015
Sponsor:
Information provided by (Responsible Party):
WON SUK AN, Dong-A University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Hemodialysis Patients
Vitamin D Insufficiency
Vitamin D Deficiency
Interventions Drug: Omega-3 fatty acid ethylester 90
Other: Olive oil
Other: cholecalciferol
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omega-3 Fatty Acid Olive Oil
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 10 7
Completed 8 7
Not Completed 2 0
Arm/Group Title Omega-3 Fatty Acid Olive Oil Total
Hide Arm/Group Description

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 8 7 15
Hide Baseline Analysis Population Description
Hemodialysis patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 15 participants
60.0  (7.3) 64.4  (8.5) 62.1  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Female
6
  75.0%
4
  57.1%
10
  66.7%
Male
2
  25.0%
3
  42.9%
5
  33.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 8 participants 7 participants 15 participants
8 7 15
1.Primary Outcome
Title 25-hydroxyvitamin D Levels at 12 Weeks
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Fatty Acid Olive Oil
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: ng/ml
44.4  (10.8) 48.9  (5.8)
2.Secondary Outcome
Title Hemoglobin Levels at 12 Weeks
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega-3 Fatty Acid Olive Oil
Hide Arm/Group Description:

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

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

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

Overall Number of Participants Analyzed 8 7
Mean (Standard Deviation)
Unit of Measure: g/dL
10.3  (0.7) 11  (1.1)
3.Secondary Outcome
Title Changes of Calcium Levels
Hide Description [Not Specified]
Time Frame 4 weeks, 8 weeks and 12 weeks
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change of Intact Parathyroid Hormone
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change of Fetuin-A Levels
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Change of FGF-23 Levels
Hide Description [Not Specified]
Time Frame 12 weeks
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Changes of Phosphorous Levels
Hide Description [Not Specified]
Time Frame 4 weeks, 8 weeks and 12 weeks
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Changes of Erythropoietin Doses
Hide Description [Not Specified]
Time Frame 4 weeks, 8 weeks and 12 weeks
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Changes of Phosphate Binder Doses
Hide Description [Not Specified]
Time Frame 4 weeks, 8 weeks and 12 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omega-3 Fatty Acid Olive Oil
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Omega-3 Fatty Acid Olive Oil
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Omega-3 Fatty Acid Olive Oil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Omega-3 Fatty Acid Olive Oil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      0/7 (0.00%)    
Reproductive system and breast disorders     
vaginal spotting   1/10 (10.00%)  1 0/7 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor
Organization: Dong-A University
Phone: 82-51-240-2811
EMail: anws@dau.ac.kr
Layout table for additonal information
Responsible Party: WON SUK AN, Dong-A University
ClinicalTrials.gov Identifier: NCT01596842     History of Changes
Other Study ID Numbers: DAU-12-073
First Submitted: May 8, 2012
First Posted: May 11, 2012
Results First Submitted: February 20, 2015
Results First Posted: March 10, 2015
Last Update Posted: March 10, 2015