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Vitamin D Repletion in Stone Formers With Hypercalciuria

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ClinicalTrials.gov Identifier: NCT01295879
Recruitment Status : Completed
First Posted : February 15, 2011
Results First Posted : October 23, 2012
Last Update Posted : October 23, 2012
Sponsor:
Information provided by (Responsible Party):
David E. Leaf, New York Presbyterian Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nephrolithiasis Urolithiasis Idiopathic Hypercalciuria Vitamin D Deficiency Disorder of Vitamin D Drug: Ergocalciferol Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Ergocalciferol Repletion on Urine Calcium Among Stone Formers With Vitamin D Deficiency and Hypercalciuria
Study Start Date : September 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : June 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Ergocalciferol
Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
 Drug: Ergocalciferol
Ergocalciferol 50,000 IU's orally per week, for 8 weeks
Other Name: Vitamin D2


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Recurrence of Kidney Stones [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295879


Locations
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United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
New York Presbyterian Hospital
More Information
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Responsible Party: David E. Leaf, Nephrology Fellow, New York Presbyterian Hospital
ClinicalTrials.gov Identifier: NCT01295879    
Other Study ID Numbers: AAAF3346
First Posted: February 15, 2011    Key Record Dates
Results First Posted: October 23, 2012
Last Update Posted: October 23, 2012
Last Verified: September 2012
Keywords provided by David E. Leaf, New York Presbyterian Hospital:
Vitamin D insufficiency
Additional relevant MeSH terms:
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Urolithiasis
Nephrolithiasis
Kidney Calculi
Vitamin D Deficiency
Hypercalciuria
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Urologic Diseases
Urinary Calculi
 Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urological Manifestations
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents