Magnesium After Alcohol Withdrawal Treatment

Alcohol-Induced Disorders Clinical Trial

Official title:

Magnesium After Alcohol Withdrawal Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00325299
• Other study ID #: FFAS-02
• Status: Completed
• Phase: Phase 4
• First received: May 11, 2006
• Last updated: May 11, 2006
• Est. completion date: September 2005

Study information

• Verified date: May 2006
• Source: Finnish Foundation for Alcohol Studies
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol-Induced Disorders

Intervention

Drug:
• Magnesium

Locations

Country	Name	City	State
Finland	Finnish Foundation for Alcohol Studies	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Finnish Foundation for Alcohol Studies

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum gamma-glutamyltransferase (GGT) activity
Secondary	Aspartate-aminotransferase (ASAT) activity
Secondary	Alanine-aminotransferase (ALAT) activity
Secondary	Depressive symptoms
Secondary	Blood pressure
Secondary	Handgrip muscle strength