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Strong enrollment efforts resulted in few eligible subjects and high screen failures due to CKD patients with higher vitamin D levels than anticipated.
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Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ergocalciferol supplementation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergocalciferol supplementation | Drug | Vitamin D in the form of ergocalciferol will be the drug utilized in the study. This medication is a Vitamin D analog and is normally used in the current study population to help augment those who are deficient in Vitamin D. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammatory Markers | 24 Weeks | |
| Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels | 24 Weeks | |
| Change in Iron Supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John J Sim, MD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
Participants were assessed for study inclusion based on chronic kidney disease (CKD) stage, age, current vitamin D levels <30 ng/ml as well as history of vitamin D levels < 30, and stable dose of erythropoietin and iron.
Recruitment began in February 2011 at Kaiser Permanente Los Angeles Medical Center. Despite strong enrollment efforts only 6 particiants were enrolled out of 10 screened.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ergocalciferol Supplementation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ergocalciferol Supplementation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements | Posted | 24 Weeks |
|
|
36 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 | Ergocalciferol Supplementation |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Hemoglobin | Blood and lymphatic system disorders |
Study terminated due to insufficient enrollment numbers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John J. Sim, MD | Kaiser Permanente | john.j.sim@kp.org |
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| 24 Weeks |
| Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders | 24 Weeks |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Secondary | Change in Inflammatory Markers | Posted | 24 Weeks |
|
|
| Secondary | Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels | Posted | 24 Weeks |
|
|
| Secondary | Change in Iron Supplementation | Posted | 24 Weeks |
|
|
| Secondary | Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders | Posted | 24 Weeks |
|
|
| 0 |
| 6 |
| 1 |
| 6 |
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