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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This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00948740
First Posted: July 29, 2009
Last Update Posted: January 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jie Tang, MD,M.Sc, Brigham and Women's Hospital
  Purpose
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 Nephrolithiasis Drug: vitamin D (ergocalciferol) Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948740


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT00948740     History of Changes
Other Study ID Numbers: 2009P000533
First Submitted: July 27, 2009
First Posted: July 29, 2009
Last Update Posted: January 9, 2017
Last Verified: January 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
Nephrolithiasis
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents