N/A
N=95
Examination of Zinc, S-adenosylmethionine, and Combination Therapy Versus Placebo in Alcoholics
Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT01899521 ↗Enrolled (actual)
95
Serious AEs
2.1%
Results posted
Sep 2024
Primary outcome: Primary: Primary Endpoint — 13518; 15892; 10849; 15530 Phagocytic Index (PI)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bronchoscopy (Procedure); Zinc sulfate 220 mg once daily (Dietary_supplement); S-adenosylmethionine 400 mg twice daily (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Endpoint |
13518; 15892; 10849; 15530; 16704; 23850 | — |
| SECONDARY Secondary Endpoint |
79.5; 76.9; 78.5; 75.0; 71.2; 95.6 | — |
Summary
This is a randomized, placebo controlled trial of dietary zinc and S-adenosylmethionine (SAMe) in otherwise healthy alcoholic US Veterans. The primary goal is to determine if either dietary zinc or S-adenosylmethionine (SAMe) can augment lung immune defenses in alcoholics and thereby decrease the risk of lung injury and infection.
Eligibility Criteria
Inclusion Criteria
- Age 18-60 years
- Active alcohol use disorder
Exclusion Criteria
- Any active and uncontrolled medical problem(s)
- Known zinc deficiency
- Primary substance of abuse something other than alcohol
- Current abnormal chest x-ray
- HIV-positive
- Any disorder of blood coagulation
- Currently on medical treatment with anti-coagulants, including:
- warfarin
- heparin
- direct thrombin inhibitors
- anti-platelet agents (other than Aspirin)
- Daily use of vitamins or other nutritional supplements (unless taking as treatment for alcohol use disorder)
- Renal impairment (GFR < 60)
- Active bipolar disorder
- Active Parkinson's disease
- Current pregnancy
- Contraindication to treatment with zinc or S-adenosylmethionine
- Inability to give informed consent (i.e., limited cognitive capacity)
- Non-English speaking
Data sourced from ClinicalTrials.gov (NCT01899521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.