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

Primary Purpose

Vitamin D Deficiency, Nephrolithiasis

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

vitamin D (ergocalciferol)

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring vitamin D

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 ≤ 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)

Sites / Locations

Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ergocalciferol

Arm Description

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.

Outcomes

Primary Outcome Measures

Urinary calcium level after treatment with ergocalciferol will be compared with the pre-treatment level. The primary outcome is the change in urinary calcium excretion.

Secondary Outcome Measures

Full Information

NCT ID

NCT00948740

First Posted

July 27, 2009

Last Updated

January 6, 2017

Sponsor

Brigham and Women's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00948740

Brief Title

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

Official Title

Phase III Study of 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

January 2017

Overall Recruitment Status

Withdrawn

Study Start Date

August 2009 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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%.

Detailed Description

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

6. Conditions and Keywords

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

Vitamin D Deficiency, Nephrolithiasis

Keywords

vitamin D

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ergocalciferol

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

vitamin D (ergocalciferol)

Other Intervention Name(s)

ergocalciferol

Intervention Description

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

Primary Outcome Measure Information:

Title

Urinary calcium level after treatment with ergocalciferol will be compared with the pre-treatment level. The primary outcome is the change in urinary calcium excretion.

Time Frame

1-2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jie Tang, M.D., M.Sc

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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