Back to resultsHypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients
Primary Purpose
Chronic Liver Disease, Hypovitaminosis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
magnesium
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Liver Disease focused on measuring Hypovitaminosis, Chronic liver disease
Eligibility Criteria
Inclusion Criteria:
chronic liver disease patients > 18 years of age Diagnosed end stage liver disease >18 years of age Presence of hypovitaminosis D Glomerular filtration rate of 60 ml/min./1.73m2 or greater
Exclusion Criteria:
subjects with known parathyroid disease subjects taking magnesium supplementation <18 years of age History of parathyroid disease Current supplementation of magnesium Abnormal baseline EKG Current diagnosis of cancer or undergoing cancer treatment
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Magnesium infusion
Outcomes
Primary Outcome Measures
Perform a standard magnesium loading test to determine urinary magnesium retention in order to define prevalence of magnesium insufficiency in a chronic liver disease population
Secondary Outcome Measures
Evaluate the effects of intravenous magnesium loading on the calcium-PTH endocrine axis by measuring pre and immediate post infusion calcium and PTH
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00599352
Brief Title
Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients
Official Title
Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rajib Bhattacharya, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine how common low levels of magnesium are in patients with end stage liver disease. In addition, investigator is trying to determine if low levels of magnesium affect the release of parathyroid hormone in patients with end stage liver disease and low vitamin D levels
Detailed Description
Hypovitaminosis D is a common condition found in patients referred for orthotopic liver transplant. The classical physiologic response to vitamin D deficiency is the development of secondary hyperparathyroidism. However, several previous studies have found a high incidence of inappropriate functional hypoparathyroidism in patients with chronic liver disease and hypovitaminosis D. The mechanism underlying this functional hypoparathyroidism is not understood but previous investigators have postulated that it is related to intracellular magnesium (Mg) deficiency. Our short term goals of this pilot project are two fold: (a) We will estimate the prevalence of magnesium deficiency in chronic liver disease patients by performing standard Mg loading testing (b) We will examine the effects of acute intravenous Mg infusion on the calcium-PTH axis. The vitamin D-PTH endocrine system is one of the principal regulators of calcium homeostasis and bone metabolism. Metabolic bone disease is a quite pervasive problem in chronic liver disease patients. Insight into this important endocrine system will aid us in our long term goals of addressing metabolic bone disease issues in this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease, Hypovitaminosis
Keywords
Hypovitaminosis, Chronic liver disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Magnesium infusion
Intervention Type
Dietary Supplement
Intervention Name(s)
magnesium
Intervention Description
Single infusion of elemental magnesium given over 4 hours, 0.2mEq/kg (2.4 mg/kg)
Primary Outcome Measure Information:
Title
Perform a standard magnesium loading test to determine urinary magnesium retention in order to define prevalence of magnesium insufficiency in a chronic liver disease population
Time Frame
One Month
Secondary Outcome Measure Information:
Title
Evaluate the effects of intravenous magnesium loading on the calcium-PTH endocrine axis by measuring pre and immediate post infusion calcium and PTH
Time Frame
One Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic liver disease patients > 18 years of age Diagnosed end stage liver disease >18 years of age Presence of hypovitaminosis D Glomerular filtration rate of 60 ml/min./1.73m2 or greater
Exclusion Criteria:
subjects with known parathyroid disease subjects taking magnesium supplementation <18 years of age History of parathyroid disease Current supplementation of magnesium Abnormal baseline EKG Current diagnosis of cancer or undergoing cancer treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajib Bhattacharya, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients
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