Vitamin D Repletion in Stone Formers With Hypercalciuria
Primary Purpose
Nephrolithiasis, Urolithiasis, Idiopathic Hypercalciuria
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ergocalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Nephrolithiasis focused on measuring Vitamin D insufficiency
Eligibility Criteria
Inclusion Criteria:
- History of nephrolithiasis as per medical record
- Urinary calcium excretion between 150 and 400 mg/day (measured within 3 months of study enrollment)
- 25(OH)D deficiency or insufficiency (defined as a serum level < 30 ng/ml) within 3 months of enrollment
Exclusion Criteria:
- Pregnant women, since the optimal dose of vitamin D supplementation in this population has not been rigorously studied.
- Known uric acid, cystine, or struvite stone disease (because our intervention is predominantly aimed at patients with calcium stone disease). An exception to this is patients who have passed both uric acid and calcium stones, or patients who have passed stones of mixed composition (uric acid and calcium).
- Hypercalcemia (serum calcium > 10.4 mg/dL) at baseline
- Acute stone event or gross hematuria (blood in the urine) within the past 2 months
- Recent stone intervention within the past 1 month
- Suspected or known secondary causes of hypercalciuria, such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except nonmelanoma skin cancer)
- Addition or dose change of medicines potentially affecting urinary calcium since the baseline 24hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)
Sites / Locations
- New York Presbyterian Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ergocalciferol
Arm Description
Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
Outcomes
Primary Outcome Measures
Change in 24 Hour Urine Calcium
Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones
Secondary Outcome Measures
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
Recurrence of Kidney Stones
Full Information
NCT ID
NCT01295879
First Posted
February 14, 2011
Last Updated
September 10, 2012
Sponsor
New York Presbyterian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01295879
Brief Title
Vitamin D Repletion in Stone Formers With Hypercalciuria
Official Title
Effect of Ergocalciferol Repletion on Urine Calcium Among Stone Formers With Vitamin D Deficiency and Hypercalciuria
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Presbyterian Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis, Urolithiasis, Idiopathic Hypercalciuria, Vitamin D Deficiency, Disorder of Vitamin D
Keywords
Vitamin D insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ergocalciferol
Arm Type
Experimental
Arm Description
Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Ergocalciferol
Other Intervention Name(s)
Vitamin D2
Intervention Description
Ergocalciferol 50,000 IU's orally per week, for 8 weeks
Primary Outcome Measure Information:
Title
Change in 24 Hour Urine Calcium
Description
Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in 24 Hour Urine Supersaturation of Calcium Oxalate
Description
Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones
Time Frame
8 weeks
Title
Recurrence of Kidney Stones
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of nephrolithiasis as per medical record
Urinary calcium excretion between 150 and 400 mg/day (measured within 3 months of study enrollment)
25(OH)D deficiency or insufficiency (defined as a serum level < 30 ng/ml) within 3 months of enrollment
Exclusion Criteria:
Pregnant women, since the optimal dose of vitamin D supplementation in this population has not been rigorously studied.
Known uric acid, cystine, or struvite stone disease (because our intervention is predominantly aimed at patients with calcium stone disease). An exception to this is patients who have passed both uric acid and calcium stones, or patients who have passed stones of mixed composition (uric acid and calcium).
Hypercalcemia (serum calcium > 10.4 mg/dL) at baseline
Acute stone event or gross hematuria (blood in the urine) within the past 2 months
Recent stone intervention within the past 1 month
Suspected or known secondary causes of hypercalciuria, such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except nonmelanoma skin cancer)
Addition or dose change of medicines potentially affecting urinary calcium since the baseline 24hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)
Facility Information:
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
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Vitamin D Repletion in Stone Formers With Hypercalciuria
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