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Completed

NCT Number: NCT01596842

Effect of Omega-3 Fatty Acid on Vitamin D Activation

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.

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Key information

Conditions

Hemodialysis Patients Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency Vitamin D Insufficiency

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Won Suk An

Busan, 602-715, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acid ethylester 90

Drug

Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks

Other names: Omacor®

olive oil

Other

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

cholecalciferol

Other

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

Primary outcomes

  1. 25-hydroxyvitamin D Levels at 12 Weeks

    Time frame: 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Dong-A University

Other

Registry information

Official study title

Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 11, 2012
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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