The Effect of Vitamin D Repletion on Kidney Stone Risk

July 19, 2019 updated by: Jie Tang, Brown University

The Effect of Vitamin D Repletion on Urinary Calcium Excretion in Kidney Stone Formers With Vitamin D Deficiency and High Urinary Calcium

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 27, 2016

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 879658-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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