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Sponsored by: |
University of Kansas |
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Information provided by: | University of Kansas |
ClinicalTrials.gov Identifier: | NCT00599352 |
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 |
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Chronic Liver Disease Hypovitaminosis |
Dietary Supplement: magnesium |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients |
Estimated Enrollment: | 30 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Magnesium infusion
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Dietary Supplement: magnesium
Single infusion of elemental magnesium given over 4 hours, 0.2mEq/kg (2.4 mg/kg)
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 |
Principal Investigator: | Rajib Bhattacharya, MD | University of Kansas |
Responsible Party: | University of Kansas Medical Center ( Rajib Bhattacharya MD ) |
Study ID Numbers: | GCRC #0083, CRA # 10345 |
Study First Received: | January 11, 2008 |
Last Updated: | January 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00599352 |
Health Authority: | United States: Institutional Review Board |
Hypovitaminosis Chronic liver disease |
Vitamin D Deficiency Liver Diseases Metabolic Diseases Avitaminosis Bone Diseases, Metabolic Bone Diseases Digestive System Diseases |
Malnutrition Musculoskeletal Diseases Rickets Nutrition Disorders Metabolic disorder Deficiency Diseases |
Calcium Metabolism Disorders |