NCT02752841

The Effect of Vitamin D Repletion on Kidney Stone Risk

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Calculi

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nutritional vitamin D repletion and maintenance	Ergocalciferol (50,000 IU weekly for 12 weeks) for vitamin D repletion, ergocalciferol (50,000 IU monthly) or cholecalciferol (1000 IU daily) for maintenance of vitamin D

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2016-04-27
• Last updated: 2019-07-23