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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 fatty acid | Active Comparator |
| |
| Olive oil | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acid ethylester 90 | Drug | Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 25-hydroxyvitamin D Levels at 12 Weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Levels at 12 Weeks | 12 weeks | |
| Changes of Calcium Levels | 4 weeks, 8 weeks and 12 weeks | |
| Change of Intact Parathyroid Hormone |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Won Suk An | Busan | 602-715 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25636157 | Derived | Lee SM, Son YK, Kim SE, An WS. The effects of omega-3 fatty acid on vitamin D activation in hemodialysis patients: a pilot study. Mar Drugs. 2015 Jan 28;13(2):741-55. doi: 10.3390/md13020741. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Hemodialysis patients
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 25-hydroxyvitamin D Levels at 12 Weeks | Posted | Mean | Standard Deviation | ng/ml | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vaginal spotting | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor | Dong-A University | 82-51-240-2811 | anws@dau.ac.kr |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D000069463 | Olive Oil |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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|
| Olive oil | Other | Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks |
|
| cholecalciferol | Other | 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 |
|
| 12 weeks |
| Change of Fetuin-A Levels | 12 weeks |
| Change of FGF-23 Levels | 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 |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Hemoglobin Levels at 12 Weeks | Posted | Mean | Standard Deviation | g/dL | 12 weeks |
|
|
|
| Secondary | Changes of Calcium Levels | Not Posted | 4 weeks, 8 weeks and 12 weeks |
| Secondary | Change of Intact Parathyroid Hormone | Not Posted | 12 weeks |
| Secondary | Change of Fetuin-A Levels | Not Posted | 12 weeks |
| Secondary | Change of FGF-23 Levels | Not Posted | 12 weeks |
| Secondary | Changes of Phosphorous Levels | Not Posted | 4 weeks, 8 weeks and 12 weeks |
| Secondary | Changes of Erythropoietin Doses | Not Posted | 4 weeks, 8 weeks and 12 weeks |
| Secondary | Changes of Phosphate Binder Doses | Not Posted | 4 weeks, 8 weeks and 12 weeks |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | 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 | 0 | 7 | 0 | 7 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |