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

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. Identifier: NCT00599352
Recruitment Status : Terminated
First Posted : January 23, 2008
Last Update Posted : May 30, 2013
Information provided by (Responsible Party):
Rajib Bhattacharya, MD, University of Kansas Medical Center

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

Condition or disease Intervention/treatment Phase
Chronic Liver Disease Hypovitaminosis Dietary Supplement: magnesium Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients
Study Start Date : January 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: 1
Magnesium infusion
Dietary Supplement: magnesium
Single infusion of elemental magnesium given over 4 hours, 0.2mEq/kg (2.4 mg/kg)

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

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

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

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 identifier (NCT number): NCT00599352

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

Responsible Party: Rajib Bhattacharya, MD, Assistant Professor, University of Kansas Medical Center Identifier: NCT00599352     History of Changes
Other Study ID Numbers: 11152
CRA # 10345
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013

Keywords provided by Rajib Bhattacharya, MD, University of Kansas Medical Center:
Chronic liver disease

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