Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients
| Tracking Information | |||||
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| First Received Date ICMJE | January 11, 2008 | ||||
| Last Updated Date | June 17, 2011 | ||||
| Start Date ICMJE | January 2008 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00599352 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients | ||||
| Official Title ICMJE | Hypovitaminosis D and an Inadequate PTH Response in Chronic Liver Disease Patients | ||||
| 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 |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Dietary Supplement: magnesium
Single infusion of elemental magnesium given over 4 hours, 0.2mEq/kg (2.4 mg/kg) |
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| Study Arm (s) | Experimental: 1
Magnesium infusion
Intervention: Dietary Supplement: magnesium |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00599352 | ||||
| Other Study ID Numbers ICMJE | 11152, CRA # 10345 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Rajib Bhattacharya MD, University of Kansas Medical Center | ||||
| Study Sponsor ICMJE | University of Kansas | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Kansas | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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