Vitamin D Repletion in Stone Formers With Hypercalciuria
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Nephrolithiasis Urolithiasis Idiopathic Hypercalciuria Vitamin D Deficiency Disorder of Vitamin D |
Drug: Ergocalciferol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Ergocalciferol Repletion on Urine Calcium Among Stone Formers With Vitamin D Deficiency and Hypercalciuria |
- Change in 24 Hour Urine Calcium [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones
- Change in 24 Hour Urine Supersaturation of Calcium Oxalate [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | September 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
No publications provided
| Responsible Party: | David E. Leaf, Nephrology Fellow, New York Presbyterian Hospital |
| ClinicalTrials.gov Identifier: | NCT01295879 History of Changes |
| Other Study ID Numbers: | AAAF3346 |
| Study First Received: | February 14, 2011 |
| Results First Received: | September 10, 2012 |
| Last Updated: | September 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York Presbyterian Hospital:
|
Vitamin D insufficiency |
Additional relevant MeSH terms:
|
Hypercalciuria Vitamin D Deficiency Nephrolithiasis Urolithiasis Urological Manifestations Signs and Symptoms Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders |
Kidney Diseases Urologic Diseases Ergocalciferols Vitamin D Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 22, 2013