NCT00599352

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 30, 2013

Status Verified

May 1, 2013

Enrollment Period

5 years

First QC Date

January 11, 2008

Last Update Submit

May 28, 2013

Conditions

Chronic Liver DiseaseHypovitaminosis

Keywords

HypovitaminosisChronic liver disease

Outcome Measures

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

    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

    One Month

Study Arms (1)

1

EXPERIMENTAL

Magnesium infusion

Dietary Supplement: magnesium

Interventions

magnesiumDIETARY_SUPPLEMENT

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Avitaminosis

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Rajib Bhattacharya, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2008

First Posted

January 23, 2008

Study Start

January 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 30, 2013

Record last verified: 2013-05

Locations

US(1)