Trial Outcomes & Findings for Examination of Zinc, S-adenosylmethionine, and Combination Therapy Versus Placebo in Alcoholics (NCT NCT01899521)
NCT ID: NCT01899521
Last Updated: 2024-09-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)
Results posted on
2024-09-19
Participant Flow
Participants are enrolled when they sign consent, however, only get randomized after completing first bronchoscopy procedure. Therefore, there were some participants who enrolled but never completed the procedure in order to be randomized into a group. This is the reason for the discrepancy in numbers.
Participant milestones
| Measure |
Placebo Zinc and Placebo SAMe
Placebo tablet of zinc sulfate once daily and placebo tablet of s-adenosylmethionine twice daily
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.
|
Active Zinc and Placebo SAMe
Zinc sulfate 220 mg once daily and placebo tablet of s-adenosylmethionine twice daily
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.
Zinc sulfate 220 mg once daily
|
Placebo Zinc and Active SAMe
Placebo tablet of zinc sulfate once daily and s-adenosylmethionine 400 mg twice daily
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.
S-adenosylmethionine 400 mg twice daily
|
Active Zinc and Active SAMe
Zinc sulfate 220 mg once daily and s-adenosylmethionine 400 mg twice daily
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.
Zinc sulfate 220 mg once daily
S-adenosylmethionine 400 mg twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
25
|
25
|
22
|
|
Overall Study
COMPLETED
|
18
|
24
|
24
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examination of Zinc, S-adenosylmethionine, and Combination Therapy Versus Placebo in Alcoholics
Baseline characteristics by cohort
| Measure |
Placebo Zinc and Placebo SAMe
n=23 Participants
Placebo tablet of zinc sulfate once daily and placebo tablet of s-adenosylmethionine twice daily
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.
|
Active Zinc and Placebo SAMe
n=25 Participants
Zinc sulfate 220 mg once daily and placebo tablet of s-adenosylmethionine twice daily
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.
Zinc sulfate 220 mg once daily
|
Placebo Zinc and Active SAMe
n=25 Participants
Placebo tablet of zinc sulfate once daily and s-adenosylmethionine 400 mg twice daily
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.
S-adenosylmethionine 400 mg twice daily
|
Active Zinc and Active SAMe
n=22 Participants
Zinc sulfate 220 mg once daily and s-adenosylmethionine 400 mg twice daily
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.
Zinc sulfate 220 mg once daily
S-adenosylmethionine 400 mg twice daily
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
46 years
n=5 Participants
|
47 years
n=7 Participants
|
47 years
n=5 Participants
|
51 years
n=4 Participants
|
48 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
92 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
77 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
22 participants
n=4 Participants
|
95 participants
n=21 Participants
|
|
Smoking Status
Smoker
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Smoking Status
Non-smoker
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)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.
Outcome measures
| Measure |
Placebo Zinc and Placebo SAMe
n=18 Participants
Placebo tablet of zinc sulfate once daily and placebo tablet of s-adenosylmethionine twice daily
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.
|
Active Zinc and Placebo SAMe
n=24 Participants
Zinc sulfate 220 mg once daily and placebo tablet of s-adenosylmethionine twice daily
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.
Zinc sulfate 220 mg once daily
|
Placebo Zinc and Active SAMe
n=24 Participants
Placebo tablet of zinc sulfate once daily and s-adenosylmethionine 400 mg twice daily
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.
S-adenosylmethionine 400 mg twice daily
|
Active Zinc and Active SAMe
n=20 Participants
Zinc sulfate 220 mg once daily and s-adenosylmethionine 400 mg twice daily
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.
Zinc sulfate 220 mg once daily
S-adenosylmethionine 400 mg twice daily
|
|---|---|---|---|---|
|
Primary Endpoint
Pre-treatment PI
|
13518 Phagocytic Index (PI)
Standard Deviation 11677
|
15892 Phagocytic Index (PI)
Standard Deviation 18961
|
10849 Phagocytic Index (PI)
Standard Deviation 11087
|
15530 Phagocytic Index (PI)
Standard Deviation 17627
|
|
Primary Endpoint
Post-treatment PI
|
16704 Phagocytic Index (PI)
Standard Deviation 15412
|
23850 Phagocytic Index (PI)
Standard Deviation 47703
|
10734 Phagocytic Index (PI)
Standard Deviation 9709
|
13955 Phagocytic Index (PI)
Standard Deviation 14511
|
SECONDARY outcome
Timeframe: Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)Improvement in alveolar macrophage intracellular zinc. Intracellular zinc will be measured before and after treatment phase using isolated alveolar macrophages. The units of measure are relative fluorescence units/cell (RFU/cell) and measured using confocal microscopy techniques.
Outcome measures
| Measure |
Placebo Zinc and Placebo SAMe
n=18 Participants
Placebo tablet of zinc sulfate once daily and placebo tablet of s-adenosylmethionine twice daily
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.
|
Active Zinc and Placebo SAMe
n=24 Participants
Zinc sulfate 220 mg once daily and placebo tablet of s-adenosylmethionine twice daily
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.
Zinc sulfate 220 mg once daily
|
Placebo Zinc and Active SAMe
n=24 Participants
Placebo tablet of zinc sulfate once daily and s-adenosylmethionine 400 mg twice daily
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.
S-adenosylmethionine 400 mg twice daily
|
Active Zinc and Active SAMe
n=20 Participants
Zinc sulfate 220 mg once daily and s-adenosylmethionine 400 mg twice daily
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.
Zinc sulfate 220 mg once daily
S-adenosylmethionine 400 mg twice daily
|
|---|---|---|---|---|
|
Secondary Endpoint
Pre-treatment Intracellular Zinc
|
2816 RFU/cell
Standard Deviation 2149
|
3410 RFU/cell
Standard Deviation 2655
|
3883 RFU/cell
Standard Deviation 2723
|
4174 RFU/cell
Standard Deviation 3386
|
|
Secondary Endpoint
Post-treatment Intracellular Zinc
|
2710 RFU/cell
Standard Deviation 1980
|
3510 RFU/cell
Standard Deviation 2590
|
4327 RFU/cell
Standard Deviation 3092
|
3103 RFU/cell
Standard Deviation 2823
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)Improvement in redox potential in the alveolar space. Redox potential will be measured before and after treatment phase using lavage fluid and blood plasma.
Outcome measures
| Measure |
Placebo Zinc and Placebo SAMe
n=18 Participants
Placebo tablet of zinc sulfate once daily and placebo tablet of s-adenosylmethionine twice daily
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.
|
Active Zinc and Placebo SAMe
n=24 Participants
Zinc sulfate 220 mg once daily and placebo tablet of s-adenosylmethionine twice daily
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.
Zinc sulfate 220 mg once daily
|
Placebo Zinc and Active SAMe
n=24 Participants
Placebo tablet of zinc sulfate once daily and s-adenosylmethionine 400 mg twice daily
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.
S-adenosylmethionine 400 mg twice daily
|
Active Zinc and Active SAMe
n=20 Participants
Zinc sulfate 220 mg once daily and s-adenosylmethionine 400 mg twice daily
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.
Zinc sulfate 220 mg once daily
S-adenosylmethionine 400 mg twice daily
|
|---|---|---|---|---|
|
Secondary Endpoint
Pre-treatment GSSG
|
33.0 GSSG percentage (measure of oxidation)
Standard Deviation 30.5
|
28.0 GSSG percentage (measure of oxidation)
Standard Deviation 29.2
|
21.6 GSSG percentage (measure of oxidation)
Standard Deviation 25.3
|
28.5 GSSG percentage (measure of oxidation)
Standard Deviation 30.6
|
|
Secondary Endpoint
Post-treatment GSSG
|
28.9 GSSG percentage (measure of oxidation)
Standard Deviation 29.2
|
19.7 GSSG percentage (measure of oxidation)
Standard Deviation 23.8
|
20.5 GSSG percentage (measure of oxidation)
Standard Deviation 26.8
|
33.5 GSSG percentage (measure of oxidation)
Standard Deviation 35.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)Population: The cells were not stained appropriately, so this secondary measure could not be completed because the results were not analyzable.
Improvement in alveolar macrophage granulocyte macrophage - colony stimulating factor (GM-CSF) receptor expression. GM-CSF receptor expression will be measured before and after treatment phase using isolated alveolar macrophages. The units of measure are relative fluorescence units/cell (RFU/cell) and measured using confocal microscopy techniques. Both alpha- and beta-subunits of the receptor will be measured.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Initial bronchoscopy to second bronchoscopy (Initial bronchoscopy performed prior to treatment and second bronchoscopy done 2-3 weeks after starting treatment)Improvement in serum zinc level. Serum zinc will be measured before and after treatment phase by collecting blood plasma. The units of measure are mcg/dl.
Outcome measures
| Measure |
Placebo Zinc and Placebo SAMe
n=18 Participants
Placebo tablet of zinc sulfate once daily and placebo tablet of s-adenosylmethionine twice daily
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.
|
Active Zinc and Placebo SAMe
n=24 Participants
Zinc sulfate 220 mg once daily and placebo tablet of s-adenosylmethionine twice daily
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.
Zinc sulfate 220 mg once daily
|
Placebo Zinc and Active SAMe
n=24 Participants
Placebo tablet of zinc sulfate once daily and s-adenosylmethionine 400 mg twice daily
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.
S-adenosylmethionine 400 mg twice daily
|
Active Zinc and Active SAMe
n=20 Participants
Zinc sulfate 220 mg once daily and s-adenosylmethionine 400 mg twice daily
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.
Zinc sulfate 220 mg once daily
S-adenosylmethionine 400 mg twice daily
|
|---|---|---|---|---|
|
Secondary Endpoint
Pre-treatment Serum Zinc
|
79.5 mcg/dl
Standard Deviation 18.5
|
76.9 mcg/dl
Standard Deviation 12.0
|
78.5 mcg/dl
Standard Deviation 12.1
|
75.0 mcg/dl
Standard Deviation 11.0
|
|
Secondary Endpoint
Post-treatment Serum Zinc
|
71.2 mcg/dl
Standard Deviation 9.7
|
95.6 mcg/dl
Standard Deviation 36.3
|
80.1 mcg/dl
Standard Deviation 14.9
|
92.0 mcg/dl
Standard Deviation 34.8
|
Adverse Events
Placebo Zinc and Placebo SAMe
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Active Zinc and Placebo SAMe
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo Zinc and Active SAMe
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Active Zinc and Active SAMe
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Zinc and Placebo SAMe
n=23 participants at risk
Placebo tablet of zinc sulfate once daily and placebo tablet of s-adenosylmethionine twice daily
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.
|
Active Zinc and Placebo SAMe
n=25 participants at risk
Zinc sulfate 220 mg once daily and placebo tablet of s-adenosylmethionine twice daily
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.
Zinc sulfate 220 mg once daily
|
Placebo Zinc and Active SAMe
n=25 participants at risk
Placebo tablet of zinc sulfate once daily and s-adenosylmethionine 400 mg twice daily
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.
S-adenosylmethionine 400 mg twice daily
|
Active Zinc and Active SAMe
n=22 participants at risk
Zinc sulfate 220 mg once daily and s-adenosylmethionine 400 mg twice daily
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.
Zinc sulfate 220 mg once daily
S-adenosylmethionine 400 mg twice daily
|
|---|---|---|---|---|
|
Vascular disorders
Subarachnoid hemorrhage
|
4.3%
1/23 • Number of events 1 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
0.00%
0/25 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
0.00%
0/25 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
0.00%
0/22 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
|
Psychiatric disorders
Alcohol withdrawal
|
0.00%
0/23 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
0.00%
0/25 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
4.0%
1/25 • Number of events 1 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
0.00%
0/22 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
Other adverse events
| Measure |
Placebo Zinc and Placebo SAMe
n=23 participants at risk
Placebo tablet of zinc sulfate once daily and placebo tablet of s-adenosylmethionine twice daily
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.
|
Active Zinc and Placebo SAMe
n=25 participants at risk
Zinc sulfate 220 mg once daily and placebo tablet of s-adenosylmethionine twice daily
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.
Zinc sulfate 220 mg once daily
|
Placebo Zinc and Active SAMe
n=25 participants at risk
Placebo tablet of zinc sulfate once daily and s-adenosylmethionine 400 mg twice daily
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.
S-adenosylmethionine 400 mg twice daily
|
Active Zinc and Active SAMe
n=22 participants at risk
Zinc sulfate 220 mg once daily and s-adenosylmethionine 400 mg twice daily
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.
Zinc sulfate 220 mg once daily
S-adenosylmethionine 400 mg twice daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
GI upset
|
21.7%
5/23 • Number of events 5 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
32.0%
8/25 • Number of events 10 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
28.0%
7/25 • Number of events 8 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
50.0%
11/22 • Number of events 16 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
|
Injury, poisoning and procedural complications
Procedure-related
|
34.8%
8/23 • Number of events 13 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
36.0%
9/25 • Number of events 10 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
32.0%
8/25 • Number of events 9 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
27.3%
6/22 • Number of events 6 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
|
Investigations
Other
|
26.1%
6/23 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
36.0%
9/25 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
32.0%
8/25 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
|
22.7%
5/22 • Up to one month following the final bronchoscopy procedure, a total of about two months. Subjects were assessed while they were enrolled and taking study medications and completed all study procedures after the second bronchoscopy. They were contacted from day following procedure up to a total 4 weeks after the final procedure date to assess for any additional adverse events. The total time period is about two months, including time during the study and after the final bronchoscopy procedure.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place