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Magnesium After Alcohol Withdrawal Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00325299
First Posted: May 12, 2006
Last Update Posted: May 12, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Finnish Foundation for Alcohol Studies
  Purpose
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.

Condition Intervention Phase
Alcohol-Induced Disorders Drug: Magnesium Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Magnesium After Alcohol Withdrawal Treatment

Resource links provided by NLM:


Further study details as provided by Finnish Foundation for Alcohol Studies:

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

Estimated Enrollment: 178
Estimated Study Completion Date: September 2005
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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00325299


Locations
Finland
Finnish Foundation for Alcohol Studies
Helsinki, Finland, 00531
Sponsors and Collaborators
Finnish Foundation for Alcohol Studies
Investigators
Principal Investigator: Kari Poikolainen, Dr Med Sci Finnish Foundation for Alcohol Studies
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00325299     History of Changes
Other Study ID Numbers: FFAS-02
First Submitted: May 11, 2006
First Posted: May 12, 2006
Last Update Posted: May 12, 2006
Last Verified: May 2006

Additional relevant MeSH terms:
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders