Clinical trial NCT00325299: Magnesium After Alcohol Withdrawal Treatment
Official title: Magnesium After Alcohol Withdrawal Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcohol-Induced Disorders
Lead sponsor: Finnish Foundation for Alcohol Studies
Sponsor class: OTHER
First posted: 2006-05-12
Enrollment: 178
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum gamma-glutamyltransferase (GGT) activity
Secondary outcomes:
measure: Aspartate-aminotransferase (ASAT) activity
measure: Alanine-aminotransferase (ALAT) activity
measure: Depressive symptoms
measure: Blood pressure
measure: Handgrip muscle strength
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Finnish Foundation for Alcohol Studies
Study officials:
affiliation: Finnish Foundation for Alcohol Studies
name: Kari Poikolainen, Dr Med Sci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poikolainen K, Alho H. Magnesium treatment in alcoholics: a randomized clinical trial. Subst Abuse Treat Prev Policy. 2008 Jan 25;3:1. doi: 10.1186/1747-597X-3-1.