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

• Status: Withdrawn
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Calcium, Dietary; Ergocalciferols; Vitamin D; Vitamins

Criteria

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)