Effect of Omega-3 Fatty Acid on Vitamin D Activation

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596842
• Other study ID #: DAU-12-073
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2012
• Last updated: March 8, 2015
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2015
• Source: Dong-A University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis Patients
• Vitamin D Deficiency
• Vitamin D Insufficiency

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Won Suk An	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25-hydroxyvitamin D Levels at 12 Weeks		12 weeks	No
Secondary	Hemoglobin Levels at 12 Weeks		12 weeks	No
Secondary	Changes of Calcium Levels		4 weeks, 8 weeks and 12 weeks	No
Secondary	Change of Intact Parathyroid Hormone		12 weeks	No
Secondary	Change of Fetuin-A Levels		12 weeks	No
Secondary	Change of FGF-23 Levels		12 weeks	No
Secondary	Changes of Phosphorous Levels		4 weeks, 8 weeks and 12 weeks	No
Secondary	Changes of Erythropoietin Doses		4 weeks, 8 weeks and 12 weeks	No
Secondary	Changes of Phosphate Binder Doses		4 weeks, 8 weeks and 12 weeks	No