Magnesium After Alcohol Withdrawal Treatment

May 11, 2006 updated by: Finnish Foundation for Alcohol Studies
The primary purpose is to see if magnesium tablet supplementation will decrease elevated GGT enzyme activity in alcoholic patients immediately after they had been treated for alcohol withdrawal. The secondary aims are to find out whether supplementation decreases the activity of ASAT and ALAT enzymes, increases muscle strength, decreases blood pressure and decreases depressive symptoms among these patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Magnesium (Mg) deficiency is common among alcoholics. Animal studies have shown that magnesium deficiency aggravates the hepatic damage caused by alcohol. One study on chronic alcoholics suggested that magnesium supplementation over six weeks decreases abnormally high activities of three enzymes related to liver function: serum gamma-glutamyltransferase (GGT), aspartate-aminotransferase (ASAT) and alanine-aminotransferase (ALAT), and increases muscle strength [4]. These results were, however, significant at the 5% level only when a 1-sided test was applied. It seems that magnesium supplementation may improve liver recovery after a drinking bout, but the evidence is not yet strong enough to warrant clear recommendations for clinical practice. Magnesium deficiency may also be one of the symptoms of depression and may aggravate hypertension. The primary purpose of the present randomized, parallel group, double blind trial is to see if oral magnesium supplementation will decrease elevated GGT enzyme activity in alcoholic patients immediately after they had been treated for alcohol withdrawal. The secondary aims are to find out whether supplementation decreases the activity of ASAT and ALAT enzymes, increases muscle strength, decreases blood pressure and decreases depressive symptoms among these patients.

Study Type

Interventional

Enrollment

178

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00531
        • Finnish Foundation for Alcohol Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission to treatment because of an acute alcohol withdrawal
  • Elevated serum GGT (men>80, women >50)
  • Age 20-64 years
  • Fixed address and a telephone to facilitate follow-up

Exclusion Criteria:

  • Mg supplementation within the past two months ten 250 mg tablets or more
  • History of heart rhythm disturbances
  • Contraindications against Mg treatment
  • Abnormally high serum creatinine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Serum gamma-glutamyltransferase (GGT) activity

Secondary Outcome Measures

Outcome Measure
Blood pressure
Depressive symptoms
Aspartate-aminotransferase (ASAT) activity
Alanine-aminotransferase (ALAT) activity
Handgrip muscle strength

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Foundation for Alcohol Studies

Investigators

  • Principal Investigator: Kari Poikolainen, Dr Med Sci, Finnish Foundation for Alcohol Studies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

May 11, 2006

First Submitted That Met QC Criteria

May 11, 2006

First Posted (ESTIMATE)

May 12, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2006

Last Update Submitted That Met QC Criteria

May 11, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFAS-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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