Trial Outcomes & Findings for Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients (NCT NCT02029521)
NCT ID: NCT02029521
Last Updated: 2016-02-08
Results Overview
Weight Percentile at 3 months adjusted for sex and age
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
3 months
Results posted on
2016-02-08
Participant Flow
Participant milestones
| Measure |
Oral Reduced L-glutathione
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
23
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Oral Reduced L-glutathione
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients
Baseline characteristics by cohort
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Oral Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
15 months to 3 years
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Age, Customized
3 years to 10 years
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Body Mass Index Percentile
|
25.1 Percentile adjusted for age and sex
STANDARD_DEVIATION 15.9 • n=5 Participants
|
31.1 Percentile adjusted for age and sex
STANDARD_DEVIATION 14.1 • n=7 Participants
|
28.3 Percentile adjusted for age and sex
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Weight Percentile
|
24.2 Percentile adjusted for sex and age
STANDARD_DEVIATION 13.7 • n=5 Participants
|
33.5 Percentile adjusted for sex and age
STANDARD_DEVIATION 13.4 • n=7 Participants
|
26.9 Percentile adjusted for sex and age
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Height Percentile
|
36.3 Percentile adjusted for weight and heigh
STANDARD_DEVIATION 14.4 • n=5 Participants
|
39.3 Percentile adjusted for weight and heigh
STANDARD_DEVIATION 13.5 • n=7 Participants
|
37.7 Percentile adjusted for weight and heigh
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Fecal Calprotectin
|
113.2 micrograms/gram feces
STANDARD_DEVIATION 52.5 • n=5 Participants
|
76.1 micrograms/gram feces
STANDARD_DEVIATION 32.2 • n=7 Participants
|
94.6 micrograms/gram feces
STANDARD_DEVIATION 47 • n=5 Participants
|
|
Forced Expiratory Volume at one second.
|
63.5 Percent predicted
STANDARD_DEVIATION 4.8 • n=5 Participants
|
71 Percent predicted
STANDARD_DEVIATION 7.8 • n=7 Participants
|
66.9 Percent predicted
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Forced Vital Capacity
|
81.8 Percent Predicted
STANDARD_DEVIATION 8.7 • n=5 Participants
|
88.2 Percent Predicted
STANDARD_DEVIATION 9.6 • n=7 Participants
|
84.7 Percent Predicted
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Gene Mutations
G551D/1303K
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
DelF508/R117H
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
R117H/G542X
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Gene Mutations
DelF508/DelF508
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Gene Mutations
DelF508/R553X
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Gene Mutations
W1282X/R347P
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
DelF508/N1303K
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Gene Mutations
DelF508/3849+10KBCT
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Gene Mutations
G551D/621+1GT
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
W1282X/DelF508
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Gene Mutations
R117H/R347P
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Gene Mutations
R117H/W1282X
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
DelF508/G542X
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Gene Mutations
3849+10kb/N1303k
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
N1303K/R553X
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
G551D/DelF508
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Gene Mutations
R117H/1466delAATT
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
DelF508/G576X
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
DelF508/S489X
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
G542X/G542X
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
DelF508/R347P
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
R117H/R117H
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Gene Mutations
N1303k/G542X
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Sweat Chloride Test
|
87.7 mmol/L
STANDARD_DEVIATION 15.8 • n=5 Participants
|
85.0 mmol/L
STANDARD_DEVIATION 15.6 • n=7 Participants
|
86.3 mmol/L
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Participants' Lipase Intake in Units Per Day
|
130909.1 units of lipase
STANDARD_DEVIATION 54590.2 • n=5 Participants
|
123181.8 units of lipase
STANDARD_DEVIATION 47044.7 • n=7 Participants
|
127045.5 units of lipase
STANDARD_DEVIATION 50512.7 • n=5 Participants
|
|
Bacteriology
A. xylososidans
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Bacteriology
MRSA
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Bacteriology
PA
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Bacteriology
Staph
|
7 participants
n=5 Participants
|
9 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Bacteriology
Normal flora
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Bacteriology
PA and S. maltophilia
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Bacteriology
PA and Staph
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Bacteriology
Staph and A. xylososidans
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
White Blood Cell Count
|
9.1 1000 cells/mm^3
STANDARD_DEVIATION 2.0 • n=5 Participants
|
8.9 1000 cells/mm^3
STANDARD_DEVIATION 2.7 • n=7 Participants
|
9.0 1000 cells/mm^3
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
ALT
|
23.2 units per liter
STANDARD_DEVIATION 9.3 • n=5 Participants
|
22.6 units per liter
STANDARD_DEVIATION 11.4 • n=7 Participants
|
22.9 units per liter
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Vitamin E
|
7.7 micrograms per ml.
STANDARD_DEVIATION 1.6 • n=5 Participants
|
7.5 micrograms per ml.
STANDARD_DEVIATION 1.6 • n=7 Participants
|
7.6 micrograms per ml.
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
C-Reactive Protein
|
13.3 miligrams per liter
STANDARD_DEVIATION 7.7 • n=5 Participants
|
12.1 miligrams per liter
STANDARD_DEVIATION 6.6 • n=7 Participants
|
12.7 miligrams per liter
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Frequency of Abdominal Pain
1- never
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Frequency of Abdominal Pain
2- rare
|
10 participants
n=5 Participants
|
4 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Frequency of Abdominal Pain
3- frequently
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Frequency of Abdominal Pain
4- constantly
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Severity of Abdominal Pain
1- absent
|
6 participants
n=5 Participants
|
11 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Severity of Abdominal Pain
2- light
|
12 participants
n=5 Participants
|
4 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Severity of Abdominal Pain
3- moderate
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Severity of Abdominal Pain
4- serious
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Frequency of Belching
1- never
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Frequency of Belching
2- rare
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Frequency of Belching
3- frequently
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Frequency of Belching
4- constantly
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Severity of Belching
1- absent
|
14 participants
n=5 Participants
|
3 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Severity of Belching
2- light
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Severity of Belching
3- moderate
|
3 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Severity of Belching
4- serious
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Frequency of Flatulence
1- never
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Frequency of Flatulence
2- rare
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Frequency of Flatulence
3- frequently
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Frequency of Flatulence
4- constantly
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Severity of Flatulence
1- absent
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Severity of Flatulence
2- light
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Severity of Flatulence
3- moderate
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Severity of Flatulence
4- serious
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Frequency of Lack of Appetite
1- never
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Frequency of Lack of Appetite
2- rare
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Frequency of Lack of Appetite
3- frequently
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Frequency of Lack of Appetite
4- constantly
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Severity of Lack of Appetite
1- absent
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Severity of Lack of Appetite
2- light
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Severity of Lack of Appetite
3- moderate
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Severity of Lack of Appetite
4- serious
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Frequency of Bloating
1- never
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Frequency of Bloating
2- rare
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Frequency of Bloating
3- frequently
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Frequency of Bloating
4- constantly
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Severity of Bloating
1- absent
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Severity of Bloating
2- light
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Severity of Bloating
3- moderate
|
13 participants
n=5 Participants
|
10 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Severity of Bloating
4- serious
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Frequency of Nausea
1- never
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Frequency of Nausea
2- rare
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Frequency of Nausea
3- frequently
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Frequency of Nausea
4- constantly
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Severity of Nausea
1- absent
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Severity of Nausea
2- light
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Severity of Nausea
3- moderate
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Severity of Nausea
4- serious
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Frequency of Vomiting
1- never
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Frequency of Vomiting
2- rare
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Frequency of Vomiting
3- frequently
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Frequency of Vomiting
4- constantly
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Severity of Vomiting
1- absent
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Severity of Vomiting
2- light
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Severity of Vomiting
3- moderate
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Severity of Vomiting
4- serious
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Frequency of Heart Burn
1- never
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Frequency of Heart Burn
2- rare
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Frequency of Heart Burn
3- frequently
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Frequency of Heart Burn
4- constantly
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Severity of Heart Burn
1- absent
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Severity of Heart Burn
2- light
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Severity of Heart Burn
3- moderate
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Severity of Heart Burn
4- serious
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Frequency of Diarrhea
1- never
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Frequency of Diarrhea
2- rare
|
9 participants
n=5 Participants
|
11 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Frequency of Diarrhea
3- frequently
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Frequency of Diarrhea
4- constantly
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Severity of Diarrhea
1- absent
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Severity of Diarrhea
2- light
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Severity of Diarrhea
3- moderate
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Severity of Diarrhea
4- serious
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Frequency of More than 2 Bowel Movements Per Day
1- never
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Frequency of More than 2 Bowel Movements Per Day
2- rare
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Frequency of More than 2 Bowel Movements Per Day
3- frequently
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Frequency of More than 2 Bowel Movements Per Day
4- constantly
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Severity of More Than 2 Bowel Movements Per Day
1- absent
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Severity of More Than 2 Bowel Movements Per Day
2- light
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Severity of More Than 2 Bowel Movements Per Day
3- moderate
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Severity of More Than 2 Bowel Movements Per Day
4- serious
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Frequency of Less Than 2 Bowel Movements Per Week
1- never
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Frequency of Less Than 2 Bowel Movements Per Week
2- rare
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Frequency of Less Than 2 Bowel Movements Per Week
3- frequently
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Frequency of Less Than 2 Bowel Movements Per Week
4- constantly
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Severity of Less Than 2 Bowel Movements Per Week
1- absent
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Severity of Less Than 2 Bowel Movements Per Week
2- light
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Severity of Less Than 2 Bowel Movements Per Week
3- moderate
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Severity of Less Than 2 Bowel Movements Per Week
4- serious
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All participants.
Weight Percentile at 3 months adjusted for sex and age
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Weight Percentile at 3 Months
|
33.5 Weight Percentile, sex and age adjusted
Standard Deviation 14.9
|
31.0 Weight Percentile, sex and age adjusted
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: All participants.
Height Percentile adjusted for sex and age
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Height Percentile
|
39.3 Percentile adjusted for age and sex
Standard Deviation 11.9
|
38.0 Percentile adjusted for age and sex
Standard Deviation 13.8
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: BMI percentile not available for children under 2 years of age.
Body Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=20 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=20 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
BMI Percentile
|
37.1 Percentile adjusted for age and sex
Standard Deviation 33.6
|
47.5 Percentile adjusted for age and sex
Standard Deviation 17.0
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All old enough to have BMI percentile calculated. BMI percentile not available for children under 2 years of age
Body Mass Index percentile adjusted for sex and age. Not available for participants under 2 years of age.
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=20 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=20 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
BMI Percentile
|
47.5 Percentile adjusted for age and sex
Standard Deviation 14.0
|
36.0 Percentile adjusted for age and sex
Standard Deviation 17.0
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants.
Weight percentile, adjusted for sex and age
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Weight Percentile
|
43.2 Percentile adjusted for age and sex
Standard Deviation 12.3
|
31.8 Percentile adjusted for age and sex
Standard Deviation 14.0
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: All participants.
The subjects were measured over the course of the study to determine if treatment improved height percentile.
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Height Percentile
|
43.3 Percentile adjusted for age and sex
Standard Deviation 12.5
|
36.5 Percentile adjusted for age and sex
Standard Deviation 13.2
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All participants.
Fecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome.
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Fecal Calprotectin
|
61.2 Micrograms/gram feces
Standard Deviation 26.4
|
76.6 Micrograms/gram feces
Standard Deviation 30.7
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Pulmonary function tests not performed on children under the age of 5
Forced vital capacity percent predicted
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=11 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=9 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Forced Vital Capacity
|
87.2 percent predicted
Standard Deviation 7.2
|
88.8 percent predicted
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Pulmonary function tests not performed on children under the age of 5
Forced expiratory volume at one second, percent predicted
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=11 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=9 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
FEV1
|
73.2 Percent predicted
Standard Deviation 5.6
|
73.0 Percent predicted
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: 3 monthsExpectorated sputum or throat swab
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Bacteriology
A. xylososidans
|
1 participants
|
0 participants
|
|
Bacteriology
MRSA
|
0 participants
|
0 participants
|
|
Bacteriology
PA
|
0 participants
|
4 participants
|
|
Bacteriology
Staph
|
12 participants
|
9 participants
|
|
Bacteriology
Normal flora
|
4 participants
|
2 participants
|
|
Bacteriology
PA and S. maltophilia
|
0 participants
|
0 participants
|
|
Bacteriology
PA and Staph
|
4 participants
|
7 participants
|
|
Bacteriology
Staph and A. xylososidans
|
0 participants
|
0 participants
|
|
Bacteriology
S. maltophilia
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: PFT's not done on children under age of 5.
Percent predicted of forced vital capacity.
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=11 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=9 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Forced Vital Capacity
|
92.3 Percent Predicted
Standard Deviation 7.3
|
83.9 Percent Predicted
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: PFT's not done on children under age of 5.
Forced expiratory volume at one second, percent predicted.
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=11 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=9 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
FEV1
|
81.5 Percent predicted
Standard Deviation 4.9
|
71.6 Percent predicted
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All participants.
CRP was measured to determine if this test fell during the course of treatment.
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
C-Reactive Protein (CRP)
|
10.9 milligrams per liter
Standard Deviation 5.6
|
14.7 milligrams per liter
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All participants.
White blood cell count was measure at the beginning and end of the study to determine if treatment affected this test.
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
White Blood Cell Count
|
8.4 1000 cells/mm^3
Standard Deviation 1.5
|
9.5 1000 cells/mm^3
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: All participants.
Serum Vitamin E levels were measured to determine if treatment affected this test.
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Vitamin E
|
8.6 milligrams per liter
Standard Deviation 1.6
|
6.8 milligrams per liter
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: All participants.
ALT was measured to determine if liver function was affected by treatment over the course of the study.
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Alanine Aminotransferase (ALT)
|
18.1 units per liter
Standard Deviation 7.0
|
25.8 units per liter
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 6 MonthsExpectorated sputum or throat swab
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Bacteriology
Noraml flora
|
6 participants
|
0 participants
|
|
Bacteriology
PA and S. maltophilia
|
0 participants
|
0 participants
|
|
Bacteriology
S. maltophilia
|
1 participants
|
1 participants
|
|
Bacteriology
Strep B
|
1 participants
|
0 participants
|
|
Bacteriology
A. xylososidans
|
0 participants
|
0 participants
|
|
Bacteriology
MRSA
|
0 participants
|
1 participants
|
|
Bacteriology
PA
|
1 participants
|
7 participants
|
|
Bacteriology
Staph
|
12 participants
|
8 participants
|
|
Bacteriology
PA and Staph
|
1 participants
|
5 participants
|
|
Bacteriology
Staph and A. xylososidans
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Frequency of Abdominal Pain
1- never
|
15 participants
|
9 participants
|
|
Frequency of Abdominal Pain
2- rare
|
6 participants
|
7 participants
|
|
Frequency of Abdominal Pain
3- frequently
|
1 participants
|
6 participants
|
|
Frequency of Abdominal Pain
4- constantly
|
0 participants
|
0 participants
|
|
Frequency of Abdominal Pain
Did Not Answer
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Severity of Abdominal Pain
3- moderate
|
0 participants
|
3 participants
|
|
Severity of Abdominal Pain
4- serious
|
0 participants
|
0 participants
|
|
Severity of Abdominal Pain
1- absent
|
14 participants
|
9 participants
|
|
Severity of Abdominal Pain
2- light
|
7 participants
|
9 participants
|
|
Severity of Abdominal Pain
Did Not Answer
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Frequency of Belching
1- never
|
18 participants
|
11 participants
|
|
Frequency of Belching
2- rare
|
4 participants
|
6 participants
|
|
Frequency of Belching
3- frequently
|
0 participants
|
5 participants
|
|
Frequency of Belching
4- constantly
|
0 participants
|
0 participants
|
|
Frequency of Belching
Did Not Answer
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Severity of Belching
1- absent
|
18 participants
|
11 participants
|
|
Severity of Belching
2- light
|
3 participants
|
6 participants
|
|
Severity of Belching
3- moderate
|
0 participants
|
4 participants
|
|
Severity of Belching
4- serious
|
0 participants
|
0 participants
|
|
Severity of Belching
Did Not Answer
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Frequency of Flatulence
1- never
|
7 participants
|
3 participants
|
|
Frequency of Flatulence
2- rare
|
14 participants
|
10 participants
|
|
Frequency of Flatulence
3- frequently
|
1 participants
|
9 participants
|
|
Frequency of Flatulence
4- constantly
|
0 participants
|
0 participants
|
|
Frequency of Flatulence
Did Not Answer
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Severity of Flatulence
1- absent
|
7 participants
|
3 participants
|
|
Severity of Flatulence
2- light
|
13 participants
|
11 participants
|
|
Severity of Flatulence
3- moderate
|
1 participants
|
7 participants
|
|
Severity of Flatulence
4- serious
|
0 participants
|
0 participants
|
|
Severity of Flatulence
Did Not Answer
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Frequency of Lack of Appetite
1- never
|
11 participants
|
4 participants
|
|
Frequency of Lack of Appetite
2- rare
|
11 participants
|
14 participants
|
|
Frequency of Lack of Appetite
3- frequently
|
0 participants
|
4 participants
|
|
Frequency of Lack of Appetite
4- constantly
|
0 participants
|
0 participants
|
|
Frequency of Lack of Appetite
Did Not Answer
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Severity of Lack of Appetite
1- absent
|
11 participants
|
3 participants
|
|
Severity of Lack of Appetite
2- light
|
10 participants
|
14 participants
|
|
Severity of Lack of Appetite
3- moderate
|
0 participants
|
4 participants
|
|
Severity of Lack of Appetite
4- serious
|
0 participants
|
0 participants
|
|
Severity of Lack of Appetite
Did Not Answer
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Frequency of Bloating
1- never
|
6 participants
|
2 participants
|
|
Frequency of Bloating
2- rare
|
14 participants
|
9 participants
|
|
Frequency of Bloating
3- frequently
|
2 participants
|
10 participants
|
|
Frequency of Bloating
4- constantly
|
0 participants
|
1 participants
|
|
Frequency of Bloating
Did Not Answer
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Severity of Bloating
1- absent
|
6 participants
|
2 participants
|
|
Severity of Bloating
2- light
|
14 participants
|
11 participants
|
|
Severity of Bloating
3- moderate
|
1 participants
|
7 participants
|
|
Severity of Bloating
4- serious
|
0 participants
|
1 participants
|
|
Severity of Bloating
Did Not Answer
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Frequency of Nausea
1- never
|
14 participants
|
14 participants
|
|
Frequency of Nausea
2- rare
|
8 participants
|
7 participants
|
|
Frequency of Nausea
3- frequently
|
0 participants
|
1 participants
|
|
Frequency of Nausea
4- constantly
|
0 participants
|
0 participants
|
|
Frequency of Nausea
Did Not Answer
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Severity of Nausea
1- absent
|
13 participants
|
13 participants
|
|
Severity of Nausea
2- light
|
8 participants
|
7 participants
|
|
Severity of Nausea
3- moderate
|
0 participants
|
1 participants
|
|
Severity of Nausea
4- serious
|
0 participants
|
0 participants
|
|
Severity of Nausea
Did Not Answer
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Frequency of Vomiting
1- never
|
21 participants
|
15 participants
|
|
Frequency of Vomiting
2- rare
|
1 participants
|
7 participants
|
|
Frequency of Vomiting
3- frequently
|
0 participants
|
0 participants
|
|
Frequency of Vomiting
4- constantly
|
0 participants
|
0 participants
|
|
Frequency of Vomiting
Did Not Answer
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Severity of Vomiting
1- absent
|
20 participants
|
14 participants
|
|
Severity of Vomiting
2- light
|
1 participants
|
7 participants
|
|
Severity of Vomiting
3- moderate
|
0 participants
|
0 participants
|
|
Severity of Vomiting
4- serious
|
0 participants
|
0 participants
|
|
Severity of Vomiting
Did Not Answer
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Frequency of Heart Burn
1- never
|
17 participants
|
18 participants
|
|
Frequency of Heart Burn
2- rare
|
5 participants
|
3 participants
|
|
Frequency of Heart Burn
3- frequently
|
0 participants
|
1 participants
|
|
Frequency of Heart Burn
4- constantly
|
0 participants
|
0 participants
|
|
Frequency of Heart Burn
Did Not Answer
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Severity of Heart Burn
1- absent
|
17 participants
|
18 participants
|
|
Severity of Heart Burn
2- light
|
4 participants
|
2 participants
|
|
Severity of Heart Burn
3- moderate
|
0 participants
|
1 participants
|
|
Severity of Heart Burn
4- serious
|
0 participants
|
0 participants
|
|
Severity of Heart Burn
Did Not Answer
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Frequency of Diarrhea
1- never
|
18 participants
|
11 participants
|
|
Frequency of Diarrhea
2- rare
|
4 participants
|
8 participants
|
|
Frequency of Diarrhea
3- frequently
|
0 participants
|
3 participants
|
|
Frequency of Diarrhea
4- constantly
|
0 participants
|
0 participants
|
|
Frequency of Diarrhea
Did Not Answer
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Severity of Diarrhea
1- absent
|
17 participants
|
10 participants
|
|
Severity of Diarrhea
2- light
|
4 participants
|
8 participants
|
|
Severity of Diarrhea
3- moderate
|
0 participants
|
3 participants
|
|
Severity of Diarrhea
4- serious
|
0 participants
|
0 participants
|
|
Severity of Diarrhea
Did Not Answer
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Frequency of More Than 2 Bowel Movements Per Day
1- never
|
15 participants
|
12 participants
|
|
Frequency of More Than 2 Bowel Movements Per Day
2- rare
|
6 participants
|
3 participants
|
|
Frequency of More Than 2 Bowel Movements Per Day
3- frequently
|
1 participants
|
7 participants
|
|
Frequency of More Than 2 Bowel Movements Per Day
4- constantly
|
0 participants
|
0 participants
|
|
Frequency of More Than 2 Bowel Movements Per Day
Did Not Answer
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Severity of More Than 2 Bowel Movements Per Day
1- absent
|
14 participants
|
12 participants
|
|
Severity of More Than 2 Bowel Movements Per Day
2- light
|
7 participants
|
4 participants
|
|
Severity of More Than 2 Bowel Movements Per Day
3- moderate
|
0 participants
|
5 participants
|
|
Severity of More Than 2 Bowel Movements Per Day
4- serious
|
0 participants
|
0 participants
|
|
Severity of More Than 2 Bowel Movements Per Day
Did Not Answer
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Frequency of Less Than 2 Bowel Movements Per Week
1- never
|
19 participants
|
16 participants
|
|
Frequency of Less Than 2 Bowel Movements Per Week
2- rare
|
3 participants
|
5 participants
|
|
Frequency of Less Than 2 Bowel Movements Per Week
3- frequently
|
0 participants
|
1 participants
|
|
Frequency of Less Than 2 Bowel Movements Per Week
4- constantly
|
0 participants
|
0 participants
|
|
Frequency of Less Than 2 Bowel Movements Per Week
Did Not Answer
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Outcome measures
| Measure |
Oral Reduced L-glutathione
n=22 Participants
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
Placebo Calcium Citrate
n=22 Participants
The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
|
|---|---|---|
|
Severity of Less Than 2 Bowel Movements Per Week
Did Not Answer
|
1 participants
|
1 participants
|
|
Severity of Less Than 2 Bowel Movements Per Week
1- absent
|
17 participants
|
15 participants
|
|
Severity of Less Than 2 Bowel Movements Per Week
2- light
|
4 participants
|
4 participants
|
|
Severity of Less Than 2 Bowel Movements Per Week
3- moderate
|
0 participants
|
2 participants
|
|
Severity of Less Than 2 Bowel Movements Per Week
4- serious
|
0 participants
|
0 participants
|
Adverse Events
Oral Reduced L-glutathione
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Calcium Citrate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place