Vitamin D Repletion in Stone Formers With Hypercalciuria

NCT ID: NCT01295879

Last Updated: 2012-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-06-30

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 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.

Conditions

Nephrolithiasis; Urolithiasis; Idiopathic Hypercalciuria; Vitamin D Deficiency; Disorder of Vitamin D

Keywords

Vitamin D insufficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ergocalciferol

Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks

Group Type: EXPERIMENTAL

Ergocalciferol

Intervention Type: DRUG

Ergocalciferol 50,000 IU's orally per week, for 8 weeks

Interventions

Ergocalciferol

Ergocalciferol 50,000 IU's orally per week, for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Vitamin D2

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York Presbyterian Hospital

OTHER

Sponsor Role: lead

Responsible Party

David E. Leaf

Nephrology Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

New York Presbyterian Hospital

New York, New York, United States

Countries

United States

Other Identifiers

AAAF3346

Identifier Type: -

Identifier Source: org_study_id