The Effect of Vitamin D on Urinary Calcium Excretion in Kidney Stone Formers With High Urinary Calcium
The recruitment status of this trial is unknown because the information has not been verified recently.
|Conditions||vitamin d deficiency, nephrolithiasis|
|Treatment||vitamin d (ergocalciferol)|
|Phase||phase 2/phase 3|
|Sponsor||Brigham and Women's Hospital|
|Start date||August 2009|
|End date||June 2010|
|Trial size||0 participants|
|Trial identifier||NCT00948740, 2009P000533|
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%.
|Intervention model||single group assignment|
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.
time frame: 1-2 years
Male or female participants at least 18 years old.
- 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)
- 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)
|Official title||Phase III Study of the Effect of Vitamin D Repletion on Urinary Calcium Excretion in Kidney Stone Formers With Vitamin D Deficiency and High Urinary Calcium|
|Principal investigator||Jie Tang, M.D., M.Sc|
|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 , 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|
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