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

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00948740
• Other study ID #: 2009P000533
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: July 27, 2009
• Last updated: January 6, 2017
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: January 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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%.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Vitamin D Deficiency

Intervention

Drug:
• vitamin D (ergocalciferol)
The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1-2 years	Yes