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Effect of Ergocalciferol Repletion on Urine Calcium Among Stone Formers With Vitamin D Deficiency and Hypercalciuria

Phase 4
18 Years
Not Enrolling
Nephrolithiasis, Urolithiasis, Idiopathic Hypercalciuria, Vitamin D Deficiency, Disorder of Vitamin D

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Trial Information

Effect of Ergocalciferol Repletion on Urine Calcium Among Stone Formers With Vitamin D Deficiency and Hypercalciuria

The investigators plan to conduct a clinic-based interventional study of 30 patients
followed at outpatient urology clinics associated with New York Presbyterian Hospital
(NYPH). The intervention is supplementation with oral ergocalciferol 50,000 IU per week for
8 weeks, and each participant will serve as his/her own control. The formulation, dose, and
duration of vitamin D therapy is reflective of that which is given in routine clinical
practice to patients with vitamin D deficiency. The outcome is the change in urinary calcium

Inclusion Criteria:

- History of nephrolithiasis as per medical record

- Urinary calcium excretion between 150 and 400 mg/day (measured within 3 months of
study enrollment)

- 25(OH)D deficiency or insufficiency (defined as a serum level < 30 ng/ml) within 3
months of enrollment

Exclusion Criteria:

- Pregnant women, since the optimal dose of vitamin D supplementation in this
population has not been rigorously studied.

- Known uric acid, cystine, or struvite stone disease (because our intervention is
predominantly aimed at patients with calcium stone disease). An exception to this is
patients who have passed both uric acid and calcium stones, or patients who have
passed stones of mixed composition (uric acid and calcium).

- Hypercalcemia (serum calcium > 10.4 mg/dL) at baseline

- Acute stone event or gross hematuria (blood in the urine) 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 nonmelanoma
skin cancer)

- Addition or dose change of medicines potentially affecting urinary calcium since the
baseline 24hour urine collection (including diuretics, magnesium supplements,
potassium supplements, potassium citrate, and vitamin D supplementation)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in 24 Hour Urine Calcium

Outcome Description:

Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones

Outcome Time Frame:

8 weeks

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

September 2010

Completion Date:

June 2011

Related Keywords:

  • Nephrolithiasis
  • Urolithiasis
  • Idiopathic Hypercalciuria
  • Vitamin D Deficiency
  • Disorder of Vitamin D
  • Vitamin D insufficiency
  • Hypercalciuria
  • Vitamin D Deficiency
  • Nephrolithiasis
  • Urolithiasis



New York Presbyterian Hospital New York, New York  10021