Vitamin D Repletion in Stone Formers With Hypercalciuria

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295879
• Other study ID #: AAAF3346
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2011
• Last updated: September 10, 2012
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: New York Presbyterian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24 Hour Urine Calcium	Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones	8 weeks	Yes
Secondary	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	Yes
Secondary	Recurrence of Kidney Stones		8 weeks	Yes