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

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Jie Tang, MD,M.Sc, Brigham and Women's Hospital Identifier:
First received: July 27, 2009
Last updated: January 6, 2017
Last verified: January 2017
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%.

Condition Intervention Phase
Vitamin D Deficiency
Drug: vitamin D (ergocalciferol)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Jie Tang, MD,M.Sc, Brigham and Women's Hospital:

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. [ Time Frame: 1-2 years ]

Enrollment: 0
Study Start Date: August 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: vitamin D (ergocalciferol)
The intervention is oral ergocalciferol 50,000 IU per week for 8 weeks
Other Name: ergocalciferol

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00948740

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Jie Tang, M.D., M.Sc Brigham and Women's Hospital
  More Information

Responsible Party: Jie Tang, MD,M.Sc, Jie Tang, M.D., M.Sc., Brigham and Women's Hospital Identifier: NCT00948740     History of Changes
Other Study ID Numbers: 2009P000533
Study First Received: July 27, 2009
Last Updated: January 6, 2017

Keywords provided by Jie Tang, MD,M.Sc, Brigham and Women's Hospital:
vitamin D

Additional relevant MeSH terms:
Vitamin D Deficiency
Kidney Calculi
Deficiency Diseases
Nutrition Disorders
Kidney Diseases
Urologic Diseases
Urinary Calculi
Pathological Conditions, Anatomical
Vitamin D
Calcium, Dietary
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on May 25, 2017