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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-06-30

Brief Summary

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The investigators hypothesize that a 3 month course of vitamin D supplementation to treat 25(OH)D deficiency in stone formers with high levels of 24-hour urinary calcium will not increase urinary calcium excretion by greater than 10%.

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Detailed Description

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We plan to conduct a clinic-based interventional study of 30 patients followed at Brigham and Women's Hospital with history of nephrolithiasis, urinary calcium excretion between 200 and 400 mg/day, and 25-vitamin D deficiency (defined as serum level ≤ 25ng/ml). The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks \[1\], and each participant will serve as his own control. The outcome is the change in urinary calcium excretion. The planned study duration is 3 months. We will have greater than 95% power to detect a 10% increase in 24-hour urinary calcium

Conditions

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Vitamin D Deficiency Nephrolithiasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ergocalciferol

After signing informed consent, all participants who meet the study criteria will receive ergocalciferol 50,000 IU weekly for 8 weeks. After completing the ergocalciferol course, participants will take a maintenance dose of cholecalciferol 1,000 IU daily.

Group Type EXPERIMENTAL

vitamin D (ergocalciferol)

Intervention Type DRUG

The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks

Interventions

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vitamin D (ergocalciferol)

The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks

Intervention Type DRUG

Other Intervention Names

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ergocalciferol

Eligibility Criteria

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Inclusion Criteria

* History of nephrolithiasis
* 25(OH)D deficiency (defined as serum level ≤ 25ng/ml) within 3 months of enrollment
* 24-hour urinary calcium excretion \> 199 mg/day and \< 400 mg/day (measured less than 6 months prior to study enrollment)

Exclusion Criteria

* Non-Caucasian
* Women of child-bearing age (age \< 50)
* 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 2 months
* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No