Hemodialysis Patients, Vitamin D Deficiency, Vitamin D Insufficiency
Conditions
Keywords
Omega-3 fatty acid, vitamin D, ergocalciferol, hemodialysis
Brief 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.
Interventions
DRUGOmega-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
OTHEROlive oil
Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
OTHERcholecalciferol
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
Sponsors
Dong-A University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 25-hydroxyvitamin D Levels at 12 Weeks | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes of Calcium Levels | 4 weeks, 8 weeks and 12 weeks |
| Change of Intact Parathyroid Hormone | 12 weeks |
| Change of Fetuin-A Levels | 12 weeks |
| Hemoglobin Levels at 12 Weeks | 12 weeks |
| Changes of Phosphorous Levels | 4 weeks, 8 weeks and 12 weeks |
| Changes of Erythropoietin Doses | 4 weeks, 8 weeks and 12 weeks |
| Changes of Phosphate Binder Doses | 4 weeks, 8 weeks and 12 weeks |
| Change of FGF-23 Levels | 12 weeks |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omega-3 Fatty Acid 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
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 | 8 |
| Olive Oil 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 | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Omega-3 Fatty Acid | Olive Oil | Total |
|---|---|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 7.3 | 64.4 years STANDARD_DEVIATION 8.5 | 62.1 years STANDARD_DEVIATION 7.9 |
| Region of Enrollment Korea, Republic of | 8 participants | 7 participants | 15 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 10 | 0 / 7 |
| serious Total, serious adverse events | 0 / 10 | 0 / 7 |
Outcome results
Primary
25-hydroxyvitamin D Levels at 12 Weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Fatty Acid | 25-hydroxyvitamin D Levels at 12 Weeks | 44.4 ng/ml | Standard Deviation 10.8 |
| Olive Oil | 25-hydroxyvitamin D Levels at 12 Weeks | 48.9 ng/ml | Standard Deviation 5.8 |
Secondary
Change of Fetuin-A Levels
Time frame: 12 weeks
Secondary
Change of FGF-23 Levels
Time frame: 12 weeks
Secondary
Change of Intact Parathyroid Hormone
Time frame: 12 weeks
Secondary
Changes of Calcium Levels
Time frame: 4 weeks, 8 weeks and 12 weeks
Secondary
Changes of Erythropoietin Doses
Time frame: 4 weeks, 8 weeks and 12 weeks
Secondary
Changes of Phosphate Binder Doses
Time frame: 4 weeks, 8 weeks and 12 weeks
Secondary
Changes of Phosphorous Levels
Time frame: 4 weeks, 8 weeks and 12 weeks
Secondary
Hemoglobin Levels at 12 Weeks
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Fatty Acid | Hemoglobin Levels at 12 Weeks | 10.3 g/dL | Standard Deviation 0.7 |
| Olive Oil | Hemoglobin Levels at 12 Weeks | 11 g/dL | Standard Deviation 1.1 |