Study Stopped
Limited study funding
The Effect of Vitamin D Repletion on Kidney Stone Risk
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Examine the effect of nutritional vitamin D repletion on urinary calcium excretion and kidney stone burden in calcium kidney stone formers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedJuly 23, 2019
July 1, 2019
3.1 years
April 20, 2016
July 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in urinary calcium excretion measured by timed urine collection
Examine changes in urine calcium excretion at the end of the 12month study. Urinary calcium excretion are measured by 24-hour urine collections for calcium (mg per day), and the differences are the changes of 24-hour urine calcium (mg per day) between those measured at month 12 and at the enrollment
Baseline and 12 months
Secondary Outcomes (1)
Changes in kidney stone burden measured by ultrasound
Baseline and 12 months
Study Arms (1)
Intervention
EXPERIMENTALNutritional vitamin D repletion and maintenance
Interventions
Ergocalciferol (50,000 IU weekly for 12 weeks) for vitamin D repletion, ergocalciferol (50,000 IU monthly) or cholecalciferol (1000 IU daily) for maintenance of vitamin D
Eligibility Criteria
You may qualify if:
- History of nephrolithiasis
- (OH)D deficiency (defined as serum level ≤ 30ng/ml) within 3 months of enrollment
- hour urinary calcium excretion \> 150 mg/day and \< 400 mg/day (measured less than 2 months prior to study enrollment)
You may not qualify if:
- Known uric acid, cystine, or struvite stone disease
- Hypercalcemia (serum calcium \>10.4 mg/dl within the past 12 months)
- Gross hematuria within the past 6 months
- Acute stone event within the past 1 month
- Recent stone intervention within the past 1 month
- Suspected or known secondary causes of hypercalciuria such as primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or malignancy (except non-melanoma skin cancer)
- Addition or dose change of medicines potentially affecting urinary calcium since enrollment 24-hour urine collection (including diuretics, magnesium supplements, potassium supplements, potassium citrate, and vitamin D supplementation)
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 20, 2016
First Posted
April 27, 2016
Study Start
May 1, 2016
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
July 23, 2019
Record last verified: 2019-07