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
  Purpose

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


Condition Intervention
Chronic Liver Disease
Hypovitaminosis
Dietary Supplement: magnesium

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients

Resource links provided by NLM:


Further study details as provided by University of Kansas:

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 [ Time Frame: One Month ] [ Designated as safety issue: No ]

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 [ Time Frame: One Month ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: January 2008
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Magnesium infusion
Dietary Supplement: magnesium
Single infusion of elemental magnesium given over 4 hours, 0.2mEq/kg (2.4 mg/kg)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599352

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Rajib Bhattacharya, MD
Investigators
Principal Investigator: Rajib Bhattacharya, MD University of Kansas
  More Information

No publications provided

Responsible Party: Rajib Bhattacharya, MD, Assistant Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00599352     History of Changes
Other Study ID Numbers: 11152, CRA # 10345
Study First Received: January 11, 2008
Last Updated: May 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
Hypovitaminosis
Chronic liver disease

Additional relevant MeSH terms:
Liver Diseases
Rickets
Avitaminosis
Digestive System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on April 16, 2014