Vitamin D Repletion in Stone Formers With Hypercalciuria

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

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.

Study Overview

• Status: Completed
• Conditions: Nephrolithiasis; Vitamin D Deficiency; Urolithiasis; Idiopathic Hypercalciuria; Disorder of Vitamin D
• Intervention / Treatment: Drug: Ergocalciferol

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Vitamin D2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24 Hour Urine Calcium	Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: New York Presbyterian Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: February 14, 2011
• First Posted (Estimate): February 15, 2011

Study Record Updates

• Last Update Posted (Estimate): October 23, 2012
• Last Update Submitted That Met QC Criteria: September 10, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Vitamin D insufficiency
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Urological Manifestations; Nutrition Disorders; Pathological Conditions, Anatomical; Avitaminosis; Deficiency Diseases; Malnutrition; Urinary Calculi; Calculi; Vitamin D Deficiency; Urolithiasis; Kidney Calculi; Nephrolithiasis; Hypercalciuria; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Ergocalciferols
• Other Study ID Numbers: AAAF3346

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No