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Effect of Omega-3 Fatty Acid on Vitamin D Activation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 Description
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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.

Condition or disease Intervention/treatment Phase
Hemodialysis Patients Vitamin D Insufficiency Vitamin D Deficiency Drug: Omega-3 fatty acid ethylester 90 Other: Olive oil Other: cholecalciferol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients
Study Start Date : May 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Vitamin D

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Omega-3 fatty acid 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 Name: Omacor®

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

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


Outcome Measures
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Primary Outcome Measures :
  1. 25-hydroxyvitamin D Levels at 12 Weeks [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Hemoglobin Levels at 12 Weeks [ Time Frame: 12 weeks ]
  2. Changes of Calcium Levels [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]
  3. Change of Intact Parathyroid Hormone [ Time Frame: 12 weeks ]
  4. Change of Fetuin-A Levels [ Time Frame: 12 weeks ]
  5. Change of FGF-23 Levels [ Time Frame: 12 weeks ]
  6. Changes of Phosphorous Levels [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]
  7. Changes of Erythropoietin Doses [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]
  8. Changes of Phosphate Binder Doses [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596842


Locations
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Korea, Republic of
Won Suk An
Busan, Korea, Republic of, 602-715
Sponsors and Collaborators
Dong-A University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: WON SUK AN, Principal Investigator, Dong-A University
ClinicalTrials.gov Identifier: NCT01596842    
Other Study ID Numbers: DAU-12-073
First Posted: May 11, 2012    Key Record Dates
Results First Posted: March 10, 2015
Last Update Posted: March 10, 2015
Last Verified: March 2015
Keywords provided by WON SUK AN, Dong-A University:
Omega-3 fatty acid
vitamin D
ergocalciferol
hemodialysis
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
 Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Bone Density Conservation Agents