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Magnesium After Alcohol Withdrawal Treatment

Primary Purpose

Alcohol-Induced Disorders

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Magnesium
Sponsored by
Finnish Foundation for Alcohol Studies
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol-Induced Disorders

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Finnish Foundation for Alcohol Studies

Outcomes

Primary Outcome Measures

Serum gamma-glutamyltransferase (GGT) activity

Secondary Outcome Measures

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

Full Information

First Posted
May 11, 2006
Last Updated
May 11, 2006
Sponsor
Finnish Foundation for Alcohol Studies
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1. Study Identification

Unique Protocol Identification Number
NCT00325299
Brief Title
Magnesium After Alcohol Withdrawal Treatment
Official Title
Magnesium After Alcohol Withdrawal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Finnish Foundation for Alcohol Studies

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Induced Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
178 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Magnesium
Primary Outcome Measure Information:
Title
Serum gamma-glutamyltransferase (GGT) activity
Secondary Outcome Measure Information:
Title
Aspartate-aminotransferase (ASAT) activity
Title
Alanine-aminotransferase (ALAT) activity
Title
Depressive symptoms
Title
Blood pressure
Title
Handgrip muscle strength

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kari Poikolainen, Dr Med Sci
Organizational Affiliation
Finnish Foundation for Alcohol Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Finnish Foundation for Alcohol Studies
City
Helsinki
ZIP/Postal Code
00531
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18218147
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. Erratum In: Subst Abuse Treat Prev Policy. 2008;3:5. Dosage error in article text.
Results Reference
derived

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Magnesium After Alcohol Withdrawal Treatment

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