Clinical Trial: Vitamin D Repletion in Stone Formers With Hypercalciuria

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: Vitamin D plays a critical role in maintaining bone health, as well as preventing cardiovascular disease, cancer, and various autoimmune diseases, such as diabetes. Vitamin D deficiency is very common in the United States and worldwide, and is now being increasingly recognized and treated. One group in which vitamin D deficiency may be particularly important is patients who have had kidney stones. These patients frequently have elevated levels of calcium in their urine, which is a common and important risk factor for calcium containing kidney stones. Because vitamin D increases absorption of calcium into the blood by the intestines, physicians may be reluctant to prescribe vitamin D therapy to patients with vitamin D deficiency if they also have kidney stones and high amounts of calcium in the urine. They are concerned about the possible risk of increasing the amount of calcium in the urine (and thereby increasing the risk of calcium stones occurring again). However, studies in patients without kidney stones, as well as studies in patients with high calcium levels in the urine, have demonstrated that giving vitamin D is effective and safe and does not increase calcium in the urine. Therefore, the investigators will study the effects of giving vitamin D on the amount of calcium in the urine in patients with a history of kidney stones and elevated calcium in the urine. The investigators will evaluate the safety of giving vitamin D to this particular group of patients.

Detailed Summary: 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 excretion.
Sponsor: New York Presbyterian Hospital

Current Primary Outcome: Change in 24 Hour Urine Calcium [ Time Frame: 8 weeks ]

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


Original Primary Outcome: 24 hour urine calcium [ Time Frame: 8 weeks ]

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


Current Secondary Outcome:

  • Change in 24 Hour Urine Supersaturation of Calcium Oxalate [ Time Frame: 8 weeks ]
    Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones
  • Recurrence of Kidney Stones [ Time Frame: 8 weeks ]


Original Secondary Outcome:

  • 24 hour urine supersaturation of calcium oxalate [ Time Frame: 8 weeks ]
    Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones
  • Recurrence of Kidney Stones [ Time Frame: 8 weeks ]


Information By: New York Presbyterian Hospital

Dates:
Date Received: February 14, 2011
Date Started: September 2010
Date Completion:
Last Updated: September 10, 2012
Last Verified: September 2012