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The Effect of Vitamin D Repletion on Kidney Stone Risk

Primary Purpose

Calculi

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nutritional vitamin D repletion and maintenance
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calculi

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of nephrolithiasis
  • 25(OH)D deficiency (defined as serum level ≤ 30ng/ml) within 3 months of enrollment
  • 24-hour urinary calcium excretion > 150 mg/day and < 400 mg/day (measured less than 2 months prior to study enrollment)

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Nutritional vitamin D repletion and maintenance

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Changes in kidney stone burden measured by ultrasound
    Changes in kidney stone burden at the end of the 12month study. Total stone burden is calculated by number of stones x stone sizes, i.e., patient A has one stone measured at 2 mm and two stones measured at 3 mm, then total stone burden = 1x2 +2x3=8mm.

    Full Information

    First Posted
    April 20, 2016
    Last Updated
    July 19, 2019
    Sponsor
    Brown University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02752841
    Brief Title
    The Effect of Vitamin D Repletion on Kidney Stone Risk
    Official Title
    The Effect of Vitamin D Repletion on Urinary Calcium Excretion in Kidney Stone Formers With Vitamin D Deficiency and High Urinary Calcium
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Terminated
    Why Stopped
    Limited study funding
    Study Start Date
    May 1, 2016 (Actual)
    Primary Completion Date
    May 31, 2019 (Actual)
    Study Completion Date
    May 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brown University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Examine the effect of nutritional vitamin D repletion on urinary calcium excretion and kidney stone burden in calcium kidney stone formers
    Detailed Description
    The investigators plan to conduct a clinic-based interventional study of 50 patients followed at Miriam Hospital Kidney Stone Clinic with history of nephrolithiasis, urinary calcium excretion between 150 and 400 mg/day, and 25-vitamin D deficiency/insufficiency (defined as serum level ≤ 30ng/ml). The intervention is oral ergocalciferol 50,000 IU per week for 12 weeks (repletion course). After that, the same repletion course will be repeated if serum 25-vitamin D remains ≤ 30ng/ml or drops to ≤ 30ng/ml anytime during the study. Otherwise, a maintenance dose of cholecalciferol 1,000 IU daily or ergocalciferol 50,000 IU monthly will be prescribed for the rest of the study. Each participant will serve as his own control. The outcome is the change in urinary calcium excretion and stone burden assessed by renal ultrasound. The planned study duration is 12 months. The investigators will have greater than 95% power to detect a 10% increase in 24-hour urinary calcium.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Calculi

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Nutritional vitamin D repletion and maintenance
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Nutritional vitamin D repletion and maintenance
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Changes in urinary calcium excretion measured by timed urine collection
    Description
    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
    Time Frame
    Baseline and 12 months
    Secondary Outcome Measure Information:
    Title
    Changes in kidney stone burden measured by ultrasound
    Description
    Changes in kidney stone burden at the end of the 12month study. Total stone burden is calculated by number of stones x stone sizes, i.e., patient A has one stone measured at 2 mm and two stones measured at 3 mm, then total stone burden = 1x2 +2x3=8mm.
    Time Frame
    Baseline and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of nephrolithiasis 25(OH)D deficiency (defined as serum level ≤ 30ng/ml) within 3 months of enrollment 24-hour urinary calcium excretion > 150 mg/day and < 400 mg/day (measured less than 2 months prior to study enrollment) Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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