Magnesium After Alcohol Withdrawal Treatment
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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 |
- Serum gamma-glutamyltransferase (GGT) activity
- Aspartate-aminotransferase (ASAT) activity
- Alanine-aminotransferase (ALAT) activity
- Depressive symptoms
- Blood pressure
- Handgrip muscle strength
| Estimated Enrollment: | 178 |
| Estimated Study Completion Date: | September 2005 |
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 |
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| Finland | |
| Finnish Foundation for Alcohol Studies | |
| Helsinki, Finland, 00531 | |
| 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 Substance-Related Disorders |
ClinicalTrials.gov processed this record on June 17, 2013