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Effect of Omega-3 Fatty Acid on Vitamin D Activation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
WON SUK AN, Dong-A University
ClinicalTrials.gov Identifier:
NCT01596842
First received: May 8, 2012
Last updated: March 8, 2015
Last verified: March 2015
  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
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

Resource links provided by NLM:


Further study details as provided by WON SUK AN, Dong-A University:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: December 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   (Adult, Senior)
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
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

Locations
Korea, Republic of
Won Suk An
Busan, Korea, Republic of, 602-715
Sponsors and Collaborators
Dong-A University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: February 20, 2015
Last Updated: March 8, 2015

Keywords provided by WON SUK AN, 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
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 18, 2017