The Effect of Vitamin D on Urinary Calcium Excretion in Kidney Stone Formers With High Urinary Calcium

Withdrawn before enrolling · Phase 2/Phase 3

Conditions studied: Vitamin D Deficiency, Nephrolithiasis

In brief

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%.

Key facts

Study ID

NCT00948740

Run by

Brigham and Women's Hospital

People needed

0

Starts

2009-08-01

Expected to finish

2010-06-01

Last updated by the study team

2017-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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