Effect of Omega-3 Fatty Acid on Vitamin D Activation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Dong-A University.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Vitamins
Vitamin D
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 19, 2014