A Phase 4 interventional study of Ergocalciferol in Nephrolithiasis, Urolithiasis and Idiopathic Hypercalciuria, sponsored by New York Presbyterian Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-23.
Sponsored by New York Presbyterian Hospital · Phase 4, Interventional, and Treatment
Among 99 studies in Nephrolithiasis with a site in United States — 21 open to participants now, 25 under way, 1 of them phase 3. Nephrolithiasis · United States.
Among the 99 studies in Nephrolithiasis with a site in United States, this one is the 55th largest by enrollment of the 87 interventional ones that give a count, is one of 4 that started in 2010, is one of 10 in phase 4, and was the 21st registered.
324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.
Browse Nephrolithiasis studies →21 of the 99 studies in Nephrolithiasis with a site in United States are open now. Recruiting first, the newest first:
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 18+
Calyxo, Inc. · Sites in United States
Ages 18+
Children's Hospital of Philadelphia · Sites in United States
Ages 6+
Ohio State University · Sites in United States
Ages 18+
The Methodist Hospital Research Institute · Sites in United States
Ages 18–70
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 51 Nephrolithiasis studies recruiting now, 30 (59%) set no upper age limit and 14 (27%) stop at 75 or younger; 2 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
99 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 13 · Phase 3 5 · Phase 4 10
First in 2002; this study’s year is marked. 4 started in 2010.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 92 across 257 interventional studies indexed under Nephrolithiasis.
Median enrollment 50 across the 87 interventional studies, 164 across the 12 observational. Of the 65 that completed or were terminated, 28 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 99 have an industry lead sponsor. The 10 most frequent:
New York Presbyterian Hospital is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
New York Presbyterian Hospital has 1 study filed under Nephrolithiasis — fewer than ten, so there is no comparison to draw.
6 of the studies in Nephrolithiasis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06930690The Methodist Hospital Research InstituteDexamethasone for Ureteral STent Symptoms (DUSTS) | 2026-12 |
| NCT06974357Ryan L SteinbergEvaluation of Genetic Abnormalities Amongst Calcium Phosphate Stone Formers | 2027-03-01 |
| NCT04669886University of MiamiSerum Endotoxin Assay to Predict the Development of Postoperative Infectious Complications and Systemic Inflammatory Response Following Percutaneous Nephrolithotomy. | 2027-03-30 |
| NCT07071831University of Kansas Medical CenterRETRO Study (RETrograde Renal Access Outcomes) | 2027-04 |
| NCT06266793MaineHealthComparison of Holmium Laser and Thulium Laser for Mini PCNL | 2027-06-01 |
Add all 6 to your calendar (.ics) → With an account.
Among the 99 studies in Nephrolithiasis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Also known as: Vitamin D2
Change in 24 Hour Urine Calcium
Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones
Time frame: 8 weeks
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
Time frame: 8 weeks
Recurrence of Kidney Stones
Time frame: 8 weeks
| Milestone | Ergocalciferol |
|---|---|
| Started | 29 |
| Completed | 29 |
| Not completed | 0 |
Elevated values of urine calcium are a risk factor for recurrence of calcium kidney stones
| mg/day | Ergocalciferol |
|---|---|
| Change in 24 Hour Urine Calcium | 2 ± 71 |
Elevated values of calcium oxalate supersaturation in the urine are a risk factor for recurrence of calcium kidney stones
| (unitless) | Ergocalciferol |
|---|---|
| Change in 24 Hour Urine Supersaturation of Calcium Oxalate | -1 ± 3.5 |
| # of stone recurrences | Ergocalciferol |
|---|---|
| Recurrence of Kidney Stones | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ergocalciferol | — | 0/29 (0%) | 0/29 (0%) |
| Age, Categorical(Participants) | Ergocalciferol |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 27 |
| >=65 years | 2 |
| Age Continuous(years) | Ergocalciferol |
|---|---|
| Mean | 48 ± 12 |
| Sex: Female, Male(Participants) | Ergocalciferol |
|---|---|
| Female | 7 |
| Male | 22 |
| Region of Enrollment(participants) | Ergocalciferol |
|---|---|
| United States | 29 |
The record gives a start of Sep 2010, a primary completion of Apr 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2012, 1 year 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ergocalciferols
New York Presbyterian Hospital