Magnesium After Alcohol Withdrawal Treatment

NCT ID: NCT00325299

Last Updated: 2006-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2005-09-30

Brief Summary

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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

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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.

Conditions

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Alcohol-Induced Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Magnesium

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Finnish Foundation for Alcohol Studies

OTHER

Sponsor Role lead

Principal Investigators

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Kari Poikolainen, Dr Med Sci

Role: PRINCIPAL_INVESTIGATOR

Finnish Foundation for Alcohol Studies

Locations

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Finnish Foundation for Alcohol Studies

Helsinki, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 18218147 (View on PubMed)

Other Identifiers

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FFAS-02

Identifier Type: -

Identifier Source: org_study_id