Vitamin D Deficiency Clinical Trial
Official title:
Effect of Omega-3 Fatty Acid on Vitamin D Activation in Hemodialysis Patients
Verified date | March 2015 |
Source | Dong-A University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Won Suk An | Busan |
Lead Sponsor | Collaborator |
---|---|
Dong-A University |
Korea, Republic of,
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 |
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