Vitamin D Repletion in Stone Formers With Hypercalciuria (NCT01295879) | Clinical Trial Compass
CompletedPhase 4
Vitamin D Repletion in Stone Formers With Hypercalciuria
United States30 participantsStarted 2010-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.