Alcohol-Induced DisordersPhase 4NCT00325299
Magnesium After Alcohol Withdrawal Treatment
A Phase 4 study testing Magnesium in people with Alcohol-Induced Disorders, run by Finnish Foundation for Alcohol Studies at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Alcohol-Induced Disorders
- What is being tested?
- Magnesium
- How many people
- 178 participants
- Where
- 1 siteFinland
- Study dates
- Start not givento Sep 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alcohol-Induced Disorders
- Being tested
- Magnesium
- Medical subject headings
- Alcohol-Induced Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum gamma-glutamyltransferase (GGT) activity
Secondary outcomes (5)
Aspartate-aminotransferase (ASAT) activity
Alanine-aminotransferase (ALAT) activity
Depressive symptoms
Blood pressure
Handgrip muscle strength
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2006 (estimated)
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol-Induced DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 178 participants
Sponsor and investigators
- Lead sponsor
- Finnish Foundation for Alcohol Studies
- Sponsor type
- University, hospital or other
- Investigators
- Kari Poikolainen, Dr Med Sci, Principal investigator, Finnish Foundation for Alcohol Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325299
- Sponsor's protocol ID
- FFAS-02
- Status last verified
- May 2006
- First submitted
- 11 May 2006
- Last updated
- 12 May 2006
- Results posted
- No
Publications
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.
PubMed 18218147
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium After Alcohol Withdrawal Treatment
- ClinicalTrials.gov ID
- NCT00325299
- Acronym / sponsor ID
- FFAS-02
- Conditions
- Alcohol-Induced Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants
- Lead sponsor
- Finnish Foundation for Alcohol StudiesUniversity, hospital or other
- Study completion
- Sep 2005
- First posted
- 12 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium | Drug | – |
Primary outcome
Serum gamma-glutamyltransferase (GGT) activity
5 secondary outcomes
Aspartate-aminotransferase (ASAT) activity
Alanine-aminotransferase (ALAT) activity
Depressive symptoms
Blood pressure
Handgrip muscle strength
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2006.
- Derived from this study: PubMed 18218147Poikolainen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari Poikolainen, Dr Med Sci principal investigator
Finnish Foundation for Alcohol Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium in people with Alcohol-Induced Disorders, run by Finnish Foundation for Alcohol Studies at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum gamma-glutamyltransferase (GGT) activity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00325299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2006.