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Magnesium After Alcohol Withdrawal Treatment

This study has been completed.
Sponsor:
Information provided by:
Finnish Foundation for Alcohol Studies
ClinicalTrials.gov Identifier:
NCT00325299
First received: May 11, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Finnish Foundation for Alcohol Studies

Additional 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
Study First Received: May 11, 2006
Last Updated: May 11, 2006
Health Authority: Finland: Finnish Medicines Agency

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

ClinicalTrials.gov processed this record on November 20, 2014