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Effect of Omega-3 Fatty Acid on Vitamin D Activation

This study is currently recruiting participants.
Verified May 2012 by Dong-A University
Sponsor:
Information provided by (Responsible Party):
WON SUK AN, Dong-A University
ClinicalTrials.gov Identifier:
NCT01596842
First received: May 8, 2012
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Vitamin D
U.S. FDA Resources

Further study details as provided by Dong-A University:

Primary Outcome Measures:
  • Changes of 25-hydroxyvitamin D and 1, 25-dihydroxyvitamin D levels [ Time Frame: 6 weeks and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of hemoglobin levels [ Time Frame: 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Changes of calcium levels [ Time Frame: 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Change of intact parathyroid hormone [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change of fetuin-A levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change of FGF-23 levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Changes of phosphorous levels [ Time Frame: 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Changes of erythropoietin doses [ Time Frame: 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • Changes of phosphate binder doses [ Time Frame: 4 weeks, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596842

Contacts
Contact: Won Suk An, M.D., Ph.D. +82-51-240-2811 anws@dau.ac.kr

Locations
Korea, Republic of
Won Suk An Recruiting
Busan, Korea, Republic of, 602-715
Contact: Won Suk An, M.D., Ph.D.     +82-51-240-2811     anws@dau.ac.kr    
Sponsors and Collaborators
Dong-A University
  More Information

No publications provided

Responsible Party: WON SUK AN, Principal Investigator, Dong-A University
ClinicalTrials.gov Identifier: NCT01596842     History of Changes
Other Study ID Numbers: DAU-12-073
Study First Received: May 8, 2012
Last Updated: May 10, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Dong-A University:
Omega-3 fatty acid
vitamin D
ergocalciferol
hemodialysis

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
 Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 22, 2013