Nephrolithiasis, Vitamin D Deficiency
Conditions
Keywords
vitamin D
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 calcium excretion by greater than 10%.
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, and 25-vitamin D deficiency (defined as serum level ≤ 25ng/ml). The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks \[1\], and each participant will serve as his own control. The outcome is the change in urinary calcium excretion. The planned study duration is 3 months. We will have greater than 95% power to detect a 10% increase in 24-hour urinary calcium
Interventions
DRUGvitamin D (ergocalciferol)
The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary calcium level after treatment with ergocalciferol will be compared with the pre-treatment level. The primary outcome is the change in urinary calcium excretion. | 1-2 years |
Countries
United States
Outcome results
None listed