Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Rajib Bhattacharya, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00599352
First received: January 11, 2008
Last updated: May 28, 2013
Last verified: May 2013

January 11, 2008
May 28, 2013
January 2008
January 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00599352 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients
Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Chronic Liver Disease
  • Hypovitaminosis
Dietary Supplement: magnesium
Single infusion of elemental magnesium given over 4 hours, 0.2mEq/kg (2.4 mg/kg)
Experimental: 1
Magnesium infusion
Intervention: Dietary Supplement: magnesium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
January 2013
January 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00599352
11152, CRA # 10345
No
Rajib Bhattacharya, MD, University of Kansas Medical Center Research Institute
Rajib Bhattacharya, MD
Not Provided
Principal Investigator: Rajib Bhattacharya, MD University of Kansas
University of Kansas
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP