The Effect of Vitamin D Repletion on Kidney Stone Risk

Calculi Clinical Trial

Official title: The Effect of Vitamin D Repletion on Urinary Calcium Excretion in Kidney Stone Formers With Vitamin D Deficiency and High Urinary Calcium

Status Terminated

Clinical Trial Summary

Examine the effect of nutritional vitamin D repletion on urinary calcium excretion and kidney stone burden in calcium kidney stone formers

Clinical Trial Description

The investigators plan to conduct a clinic-based interventional study of 50 patients followed at Miriam Hospital Kidney Stone Clinic with history of nephrolithiasis, urinary calcium excretion between 150 and 400 mg/day, and 25-vitamin D deficiency/insufficiency (defined as serum level ≤ 30ng/ml). The intervention is oral ergocalciferol 50,000 IU per week for 12 weeks (repletion course). After that, the same repletion course will be repeated if serum 25-vitamin D remains ≤ 30ng/ml or drops to ≤ 30ng/ml anytime during the study. Otherwise, a maintenance dose of cholecalciferol 1,000 IU daily or ergocalciferol 50,000 IU monthly will be prescribed for the rest of the study. Each participant will serve as his own control. The outcome is the change in urinary calcium excretion and stone burden assessed by renal ultrasound. The planned study duration is 12 months. The investigators will have greater than 95% power to detect a 10% increase in 24-hour urinary calcium. ;

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis

• NCT number: NCT02752841
• Study type: Interventional
• Source: Brown University
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2016
• Completion date: May 31, 2019