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

NCT01899521 | Completed Results DMC

• 3 other identifiers: PULM-038-12SIRB00060773IK2CX000643
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

alcoholism; lung health; pulmonary; macrophage; zinc; SAMe; S-adenosylmethionine; alveolar

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Improvement in alveolar macrophage phagocytic index. Phagocytic index will be measured before and after treatment phase. Phagocytic index is calculated using isolated alveolar macrophages from the bronchoscopy procedure such that phagocytic index = (total number of engulfed cells/total number of counted macrophages) x (number of macrophages containing engulfed cells/total number of counted macrophages) x 100.

  Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)

Secondary Outcomes (1)

• Secondary Endpoint

  Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)

Other Outcomes (3)

• Secondary Endpoint

  Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)

• Secondary Endpoint

  Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)

• Secondary Endpoint

  Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)

Study Arms (4)

Placebo zinc and placebo SAMe

PLACEBO COMPARATOR

Placebo tablet of zinc sulfate once daily and placebo tablet of s-adenosylmethionine twice daily

Procedure: Bronchoscopy

Active zinc and placebo SAMe

ACTIVE COMPARATOR

Zinc sulfate 220 mg once daily and placebo tablet of s-adenosylmethionine twice daily

Procedure: Bronchoscopy; Dietary Supplement: Zinc sulfate 220 mg once daily

Placebo zinc and active SAMe

ACTIVE COMPARATOR

Placebo tablet of zinc sulfate once daily and s-adenosylmethionine 400 mg twice daily

Procedure: Bronchoscopy; Dietary Supplement: S-adenosylmethionine 400 mg twice daily

Active zinc and active SAMe

ACTIVE COMPARATOR

Zinc sulfate 220 mg once daily and s-adenosylmethionine 400 mg twice daily

Procedure: Bronchoscopy; Dietary Supplement: Zinc sulfate 220 mg once daily; Dietary Supplement: S-adenosylmethionine 400 mg twice daily

Interventions

Bronchoscopy PROCEDURE

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.

Active zinc and active SAMe; Active zinc and placebo SAMe; Placebo zinc and active SAMe; Placebo zinc and placebo SAMe

Zinc sulfate 220 mg once daily DIETARY_SUPPLEMENT

Active zinc and active SAMe; Active zinc and placebo SAMe

S-adenosylmethionine 400 mg twice daily DIETARY_SUPPLEMENT

Also known as: SAMe

Active zinc and active SAMe; Placebo zinc and active SAMe

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years
• Active alcohol use disorder

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Bronchoscopy; Zinc Sulfate; S-Adenosylmethionine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Methionine; Amino Acids, Sulfur; Organic Chemicals; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amino Acids; Amino Acids, Peptides, and Proteins; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Dr. Ashish Mehta
• Organization: Atlanta VA Medical Center

Ashish.Mehta@va.gov

404-321-6111

Study Officials

• Ashish Mehta, MD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 15, 2013
• Study Start: May 1, 2013
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Locations

US (1)