Effect of Omega-3 Fatty Acid on Vitamin D Activation

Dong-A University

Status and phase: Completed; Phase 4

Conditions: Hemodialysis Patients; Vitamin D Deficiency; Vitamin D Insufficiency

Treatments: Other: Olive oil; Drug: Omega-3 fatty acid ethylester 90; Other: cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01596842

DAU-12-073

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 2 patient groups, including a placebo group

Omega-3 fatty acid

Active Comparator group

Treatment:

Other: cholecalciferol

Drug: Omega-3 fatty acid ethylester 90

Olive oil

Placebo Comparator group

Treatment:

Other: cholecalciferol

Other: Olive oil