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

Overview

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%.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2010

Detailed 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

Interventions

  • Drug: vitamin D (ergocalciferol)
    • The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks

Arms, Groups and Cohorts

  • Experimental: ergocalciferol
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jie Tang, MD,M.Sc, Jie Tang, M.D., M.Sc. – Brigham and Women’s Hospital
  • Overall Official(s)
    • Jie Tang, M.D., M.Sc, Principal Investigator, Brigham and Women’s Hospital

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