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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

Tracking Information
First Submitted Date  ICMJE May 8, 2012
First Posted Date  ICMJE May 11, 2012
Results First Submitted Date  ICMJE February 20, 2015
Results First Posted Date  ICMJE March 10, 2015
Last Update Posted Date March 10, 2015
Study Start Date  ICMJE May 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2015)
25-hydroxyvitamin D Levels at 12 Weeks [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
Changes of 25-hydroxyvitamin D and 1, 25-dihydroxyvitamin D levels [ Time Frame: 6 weeks and 12 weeks ]
Change History Complete list of historical versions of study NCT01596842 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2015)
  • Hemoglobin Levels at 12 Weeks [ Time Frame: 12 weeks ]
  • Changes of Calcium Levels [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]
  • Change of Intact Parathyroid Hormone [ Time Frame: 12 weeks ]
  • Change of Fetuin-A Levels [ Time Frame: 12 weeks ]
  • Change of FGF-23 Levels [ Time Frame: 12 weeks ]
  • Changes of Phosphorous Levels [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]
  • Changes of Erythropoietin Doses [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]
  • Changes of Phosphate Binder Doses [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2012)
  • Changes of hemoglobin levels and erythropoietin doses per 4 weeks [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]
  • Changes of calcium, phosphorous levels and phosphate binder doses per 4 weeks [ Time Frame: 4 weeks, 8 weeks and 12 weeks ]
  • Change of Intact Parathyroid Hormone [ Time Frame: 12 weeks ]
  • Change of Fetuin-A Levels [ Time Frame: 12 weeks ]
  • Change of FGF-23 Levels [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Omega-3 Fatty Acid on Vitamin D Activation
Official Title  ICMJE Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Hemodialysis Patients
  • Vitamin D Insufficiency
  • Vitamin D Deficiency
Intervention  ICMJE
  • 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: 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
Study Arms  ICMJE
  • Active Comparator: Omega-3 fatty acid
    Interventions:
    • Drug: Omega-3 fatty acid ethylester 90
    • Other: cholecalciferol
  • Placebo Comparator: Olive oil
    Interventions:
    • Other: Olive oil
    • Other: cholecalciferol
Publications * Lee SM, Son YK, Kim SE, An WS. The effects of omega-3 fatty acid on vitamin D activation in hemodialysis patients: a pilot study. Mar Drugs. 2015 Jan 28;13(2):741-55. doi: 10.3390/md13020741.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2015)
17
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2012)
20
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01596842
Other Study ID Numbers  ICMJE DAU-12-073
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party WON SUK AN, Dong-A University
Study Sponsor  ICMJE Dong-A University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dong-A University
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP