CClinicalTrials.gg
TerminatedNCT00599352Updated May 30, 2013

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

An interventional study of magnesium in Chronic Liver Disease and Hypovitaminosis, sponsored by Rajib Bhattacharya, MD. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-30.

Sponsored by Rajib Bhattacharya, MD · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Chronic Liver Disease
  • Hypovitaminosis

Keywords

  • Hypovitaminosis
  • Chronic liver disease
03

In context

Rickets

92 studies on the registry are indexed under Rickets; 5 are open to participants now.

This study's enrollment of 14 is below the median of 53 across 62 interventional studies indexed under Rickets.

Browse Rickets studies →

Lead sponsor

This is the only study on the registry with Rajib Bhattacharya, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    1

    Magnesium infusion

    Dietary Supplement: magnesium

Interventions

  • Dietary supplementmagnesium

    Single infusion of elemental magnesium given over 4 hours, 0.2mEq/kg (2.4 mg/kg)

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00599352
Lead sponsor
Rajib Bhattacharya, MD
Responsible party
Rajib Bhattacharya, MD (Assistant Professor, University of Kansas Medical Center) — Sponsor-investigator
First posted
Jan 23, 2008
Start date
Jan 2008
Primary completion
Jan 2013
Completion
Jan 2013
Last update
May 30, 2013

Study contacts

Rajib Bhattacharya, MD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion