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A few studies have reported erythropoiesis-stimulating agent (ESA) doses before and after 25D supplementation, but only one of these is a prospective clinical trial, and it is a small, single center study lacking a control arm. The investigators propose to conduct a double blind, randomized, placebo controlled clinical trial of ergocalciferol supplementation to confirm safety and determine effects on Erythropoietin (EPO) dosing, active D dosing, and mineral metabolic parameters in hemodialysis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ergocalciferol supplementation | Other |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ergocalciferol supplementation | Dietary Supplement | 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| EPO Dose | The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation. | Baseline, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Miskulin, MD | DCI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DCI - Redding | Redding | California | 96003 | United States | ||
| DCI - Albany |
470 subjects were enrolled in the study; however 151 subjects did not make it to randomization due to EPO criteria not met n=45, did not meet other inclusion criteria n=57, no was reason provided n=49. Of the 319 subjects randomized, 43 had a baseline 25(OH)D >30. This analysis only pertains to the 276 subjects with a baseline 25(OH)D ≤30.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ergocalciferol Supplementation | ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly |
| FG001 | Placebo | placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| placebo | Other | placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly |
|
|
| Albany |
| Georgia |
| 31701 |
| United States |
| DCI - Shreveport | Shreveport | Louisiana | 71103 | United States |
| DCI - Boston | Boston | Massachusetts | 02111 | United States |
| DCI- Columbia | Columbia | Missouri | 65201 | United States |
| DCI - Kansas City | Kansas City | Missouri | 64131 | United States |
| DCI- Omaha | Omaha | Nebraska | 68131 | United States |
| DCI - New Brunswick | New Brunswick | New Jersey | 08903 | United States |
| DCI - North Brunswick | North Brunswick | New Jersey | 08902 | United States |
| DCI - Philadelphia | Philadelphia | Pennsylvania | 19129 | United States |
| DCI - Knoxville | Knoxville | Tennessee | 37924 | United States |
| DCI - Maryville | Maryville | Tennessee | 37804 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ergocalciferol Supplementation | ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly |
| BG001 | Placebo | placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| 25Vit D (ng/mL) | Mean | Standard Deviation | ng/mL |
| |||||||||||||||
| Epogen Dose, units/week | Median | Inter-Quartile Range | units/week |
|
| 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 | EPO Dose | The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation. | Posted | Median | Inter-Quartile Range | units/week | Baseline, 6 months |
|
|
|
|
6 months
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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 | Ergocalciferol Supplementation | ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly | 4 | 137 | 9 | 137 | ||
| EG001 | Placebo | placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly | 4 | 139 | 8 | 139 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
PI agrees that the first publication and presentation shall be made by sponsor. If publication is not made within 24 months PI may publish their site data provided that sponsor receives 30 days to review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Majchrzak | Dialysis Clinic Inc | 615-342-0483 | karen.majchrzak@dciinc.org |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|