Magnesium After Alcohol Withdrawal Treatment

Phase 4

Completed

• Conditions: Alcohol-Induced Disorders

• Registration Number: NCT00325299
• Lead Sponsor: Finnish Foundation for Alcohol Studies

Brief Summary

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.

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 Timeline

• Study Completion: 2005-09
• Status Verified: 2006-05
• Study First Submitted: 2006-05-11
• Study First Submitted QC: 2006-05-11
• Last Update Submitted: 2006-05-11
• Study First Posted: 2006-05-12
• Last Update Posted: 2006-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Serum gamma-glutamyltransferase (GGT) activity

Secondary Outcome Measures

Name	Time	Method
Blood pressure
Handgrip muscle strength
Aspartate-aminotransferase (ASAT) activity
Alanine-aminotransferase (ALAT) activity
Depressive symptoms

Trial Locations

Locations (1)

Finnish Foundation for Alcohol Studies; 🇫🇮 Helsinki, Finland