Overview

This trial is active, not recruiting.

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 30 participants
Trial identifier NCT00948740, 2009P000533

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%.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
After signing informed consent, all participants who meet the study criteria will receive ergocalciferol 50,000 IU weekly for 8 weeks. After completing the ergocalciferol course, participants will take a maintenance dose of cholecalciferol 1,000 IU daily.
vitamin d (ergocalciferol) ergocalciferol
The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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 [1], 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
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.