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

Not Applicable

Terminated

• Conditions: Chronic Liver Disease; Hypovitaminosis
• Interventions: Dietary Supplement: magnesium

• Registration Number: NCT00599352
• Lead Sponsor: Rajib Bhattacharya, MD

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-11
• Study First Posted: 2008-01-23
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-28
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	magnesium	Magnesium infusion

Primary Outcome Measures

Name	Time	Method
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	One Month

Secondary Outcome Measures

Name	Time	Method
Evaluate the effects of intravenous magnesium loading on the calcium-PTH endocrine axis by measuring pre and immediate post infusion calcium and PTH	One Month

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States