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The Effect of Vitamin D Repletion on Kidney Stone Risk

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ClinicalTrials.gov Identifier: NCT02752841
Recruitment Status : Terminated (Limited study funding)
First Posted : April 27, 2016
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jie Tang, Brown University

Brief Summary:
Examine the effect of nutritional vitamin D repletion on urinary calcium excretion and kidney stone burden in calcium kidney stone formers

Condition or disease Intervention/treatment Phase
Calculi Dietary Supplement: Nutritional vitamin D repletion and maintenance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin D Repletion on Urinary Calcium Excretion in Kidney Stone Formers With Vitamin D Deficiency and High Urinary Calcium
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Intervention
Nutritional vitamin D repletion and maintenance
Dietary Supplement: Nutritional vitamin D repletion and maintenance
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 Measures :
  1. Changes in urinary calcium excretion measured by timed urine collection [ Time Frame: Baseline and 12 months ]
    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 :
  1. Changes in kidney stone burden measured by ultrasound [ Time Frame: Baseline and 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Jie Tang, Associate Professor, Brown University
ClinicalTrials.gov Identifier: NCT02752841    
Other Study ID Numbers: 879658-1
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Kidney Calculi
Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Pathological Conditions, Anatomical
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents