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

NCT00948740 | Withdrawn Phase 2

• 1 other identifier: 2009P000533
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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%.

Conditions

Vitamin D Deficiency; Nephrolithiasis

Keywords

vitamin D

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ergocalciferol

EXPERIMENTAL

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.

Drug: vitamin D (ergocalciferol)

Interventions

vitamin D (ergocalciferol) DRUG

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

Also known as: ergocalciferol

ergocalciferol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Nephrolithiasis

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Jie Tang, M.D., M.Sc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jie Tang, M.D., M.Sc.

Study Record Dates

• First Submitted: July 27, 2009
• First Posted: July 29, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

US (1)