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Examination of Zinc, S-adenosylmethionine, and Combination Therapy Versus Placebo in Alcoholics

NCT01899521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Alcoholism

Interventions

PROCEDURE

Bronchoscopy

Involves flexible fiberoptic bronchoscopy with standardized bronchoalveolar lavage (BAL) technique (isotonic saline in a sub-segment of the right middle lobe or lingula) using standard conscious sedation techniques.

DIETARY_SUPPLEMENT

Zinc sulfate 220 mg once daily

DIETARY_SUPPLEMENT

S-adenosylmethionine 400 mg twice daily

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Ashish Mehta, MD · Atlanta VA Medical and Rehab Center, Decatur, GA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-01
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01899521 on ClinicalTrials.gov