NCT00325299

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
Last Updated

May 12, 2006

Status Verified

May 1, 2006

First QC Date

May 11, 2006

Last Update Submit

May 11, 2006

Conditions

Alcohol-Induced Disorders

Outcome Measures

Primary Outcomes (1)

  • Serum gamma-glutamyltransferase (GGT) activity

Secondary Outcomes (5)

  • Aspartate-aminotransferase (ASAT) activity

  • Alanine-aminotransferase (ALAT) activity

  • Depressive symptoms

  • Blood pressure

  • Handgrip muscle strength

Interventions

MagnesiumDRUG

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Finnish Foundation for Alcohol Studies

Helsinki, 00531, Finland

Location

Related Publications (1)

  • 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.

    PMID: 18218147DERIVED

MeSH Terms

Conditions

Alcohol-Induced Disorders

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Kari Poikolainen, Dr Med Sci

    Finnish Foundation for Alcohol Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2006

First Posted

May 12, 2006

Study Completion

September 1, 2005

Last Updated

May 12, 2006

Record last verified: 2006-05

Locations

FI(1)