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Vitamin D plays a critical role in maintaining bone health, as well as preventing cardiovascular disease, cancer, and various autoimmune diseases, such as diabetes. Vitamin D deficiency is very common in the United States and worldwide, and is now being increasingly recognized and treated. One group in which vitamin D deficiency may be particularly important is patients who have had kidney stones. These patients frequently have elevated levels of calcium in their urine, which is a common and important risk factor for calcium containing kidney stones. Because vitamin D increases absorption of calcium into the blood by the intestines, physicians may be reluctant to prescribe vitamin D therapy to patients with vitamin D deficiency if they also have kidney stones and high amounts of calcium in the urine. They are concerned about the possible risk of increasing the amount of calcium in the urine (and thereby increasing the risk of calcium stones occurring again). However, studies in patients without kidney stones, as well as studies in patients with high calcium levels in the urine, have demonstrated that giving vitamin D is effective and safe and does not increase calcium in the urine. Therefore, the investigators will study the effects of giving vitamin D on the amount of calcium in the urine in patients with a history of kidney stones and elevated calcium in the urine. The investigators will evaluate the safety of giving vitamin D to this particular group of patients.
The investigators plan to conduct a clinic-based interventional study of 30 patients followed at outpatient urology clinics associated with New York Presbyterian Hospital (NYPH). The intervention is supplementation with oral ergocalciferol 50,000 IU per week for 8 weeks, and each participant will serve as his/her own control. The formulation, dose, and duration of vitamin D therapy is reflective of that which is given in routine clinical practice to patients with vitamin D deficiency. The outcome is the change in urinary calcium excretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ergocalciferol | Experimental | Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ergocalciferol | Drug | Ergocalciferol 50,000 IU's orally per week, for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24 Hour Urine Calcium | Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24 Hour Urine Supersaturation of Calcium Oxalate | Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones | 8 weeks |
| Recurrence of Kidney Stones |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Presbyterian Hospital | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ergocalciferol | Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ergocalciferol | Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks |
| 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 | Change in 24 Hour Urine Calcium | Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones | Posted | Mean | Standard Deviation | mg/day | 8 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 | Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David E. Leaf, M.D., Renal Fellow | Brigham and Women's Hospital | 617-732-5951 | DELEAF@partners.org |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D052878 | Urolithiasis |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 8 weeks |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Change in 24 Hour Urine Supersaturation of Calcium Oxalate | Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones | Posted | Mean | Standard Deviation | (unitless) | 8 weeks |
|
|
|
| Secondary | Recurrence of Kidney Stones | Posted | Number | # of stone recurrences | 8 weeks |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |