Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients
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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 |
- 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 ]
- 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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 |
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| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| Principal Investigator: | Rajib Bhattacharya, MD | University of Kansas |
More Information
No publications provided
| Responsible Party: | Rajib Bhattacharya MD, University of Kansas Medical Center |
| ClinicalTrials.gov Identifier: | NCT00599352 History of Changes |
| Other Study ID Numbers: | 11152, CRA # 10345 |
| Study First Received: | January 11, 2008 |
| Last Updated: | June 17, 2011 |
| 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 May 16, 2013