Phase 4 N=17 Randomized Double-blind Treatment

Effect of Omega-3 Fatty Acid on Vitamin D Activation

Hemodialysis Patients · Vitamin D Insufficiency · Vitamin D Deficiency

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View on ClinicalTrials.gov: NCT01596842 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2015

Primary outcome: Primary: 25-hydroxyvitamin D Levels at 12 Weeks — 44.4; 48.9 ng/ml

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Omega-3 fatty acid ethylester 90 (Drug); Olive oil (Other); cholecalciferol (Other)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Dong-A University
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY 25-hydroxyvitamin D Levels at 12 Weeks	44.4; 48.9	—
SECONDARY Hemoglobin Levels at 12 Weeks	10.3; 11	—
SECONDARY Changes of Calcium Levels	—	—
SECONDARY Change of Intact Parathyroid Hormone	—	—
SECONDARY Change of Fetuin-A Levels	—	—
SECONDARY Change of FGF-23 Levels	—	—
SECONDARY Changes of Phosphorous Levels	—	—
SECONDARY Changes of Erythropoietin Doses	—	—
SECONDARY Changes of Phosphate Binder Doses	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01596842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.