Status:
WITHDRAWN
The Effect of Vitamin D on Urinary Calcium Excretion in Kidney Stone Formers With High Urinary Calcium
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Vitamin D Deficiency
Nephrolithiasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators hypothesize that a 3 month course of vitamin D supplementation to treat 25(OH)D deficiency in stone formers with high levels of 24-hour urinary calcium will not increase urinary calc...
Detailed Description
We plan to conduct a clinic-based interventional study of 30 patients followed at Brigham and Women's Hospital with history of nephrolithiasis, urinary calcium excretion between 200 and 400 mg/day, an...
Eligibility Criteria
Inclusion
- History of nephrolithiasis
- 25(OH)D deficiency (defined as serum level ≤ 25ng/ml) within 3 months of enrollment
- 24-hour urinary calcium excretion \> 199 mg/day and \< 400 mg/day (measured less than 6 months prior to study enrollment)
Exclusion
- Non-Caucasian
- Women of child-bearing age (age \< 50)
- Known uric acid, cystine, or struvite stone disease
- Hypercalcemia (serum calcium \> 10.4 mg/dl within the past 12 months)
- Gross hematuria within the past 6 months
- Acute stone event 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 non-melanoma skin cancer)
- Addition or dose change of medicines potentially affecting urinary calcium since enrollment 24-hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00948740
Start Date
August 1 2009
End Date
June 1 2010
Last Update
January 9 2017
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115