An interventional study of Ergocalciferol supplementation in Chronic Kidney Disease Stages 3-5, sponsored by Kaiser Permanente. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-30.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 6 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Ergocalciferol supplementation
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.
Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements
Time frame: 24 Weeks
Change in Inflammatory Markers
Time frame: 24 Weeks
Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels
Time frame: 24 Weeks
Change in Iron Supplementation
Time frame: 24 Weeks
Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders
Time frame: 24 Weeks
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.
| Milestone | Ergocalciferol Supplementation |
|---|---|
| Started | 6 |
| Completed | 0 |
| Not completed | 6 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Study terminated due to low enrollment. | 4 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over 36 Weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ergocalciferol Supplementation | — | 0/6 (0%) | 1/6 (16.7%) |
| Event | Ergocalciferol Supplementation |
|---|---|
| Low HemoglobinBlood and lymphatic system disorders | 1/6 |
| Age, Categorical(Participants) | Ergocalciferol Supplementation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 5 |
| Sex: Female, Male(Participants) | Ergocalciferol Supplementation |
|---|---|
| Female | 3 |
| Male | 3 |
| Region of Enrollment(participants) | Ergocalciferol Supplementation |
|---|---|
| United States | 6 |
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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