FindTrial
Sign In

Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients

Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis for Growth Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02029521
Enrollment
47
Registered
2014-01-08
Start date
2011-03-31
Completion date
2012-07-31
Last updated
2016-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis, growth Failure, glutathione

Brief summary

Many individuals with cystic fibrosis experience growth failure. The reasons are not clear, but inflammation of the gut in these patients seems to be one important reason. Glutathione is important to normal function of the intestine and lungs. Glutathione functions to decrease inflammation and to thin mucus. However, in cystic fibrosis, glutathione gets trapped inside of cells, so it cannot travel to the surface of the cells and perform its proper function. Moreover, glutathione has been shown to improve nutritional status in patients with AIDS and cancer. Investigators hypothesize that supplementation of oral glutathione to pediatric individuals with cystic fibrosis could improve growth failure.

Detailed description

Cystic fibrosis (CF) is known principally for its pulmonary consequences. However, for most individuals with CF, the earliest manifestations are not pulmonary, but gastro-intestinal. Many children experience growth failure. Chronic gut inflammation also develops. Research has also established that lung function scores are significantly correlated with Body Mass Index (BMI) and weight percentile in CF. Therefore, interventions to improve the gastro-intestinal dimension of CF in early childhood have the potential to ameliorate the course of the disease over the life span of the patient. Both Cochrane Database reviews and a recent review commissioned by the Cystic Fibrosis Foundation found only fair evidence for current nutritional guidelines.Therefore, there is a pressing need for a treatment for CF growth failure that is more effective and less invasive than current treatments. The discovery that CF is associated with significantly diminished efflux of reduced glutathione (GSH) from most cells in the body offers a new perspective on the pathophysiology of this disease. GSH plays several important roles; among the most important are the following: 1) primary water-soluble antioxidant; 2) mucolytic capable of cleaving disulfide bonds; and 3) regulator of immune system function. The relationship between redox ratio (GSH:GSSG) and total glutathione (GSH+GSSG) and the initiation of inflammation is well established in the research literature. GSH is also an important component of the epithelial lining fluid of the intestines, helping to keep intestinal mucus thin, serving to defend the intestinal system against reactive oxygen species, and keeping inflammation in check under normal circumstances. GSH is an FDA-approved treatment for AIDS-related cachexia. The growing recognition of GSH system dysfunction in CF, coupled with an established research literature on the role of GSH in gastro-intestinal function and weight gain in non-CF contexts, suggest a new intervention for growth failure in early childhood in CF patients. Specifically, investigators hypothesized that oral glutathione could effectively treat CF growth failure in pediatric patients.

Interventions

DIETARY_SUPPLEMENTOral 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.

DIETARY_SUPPLEMENTPlacebo

calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

Sponsors

Clark Bishop
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Months to 10 Years
Healthy volunteers
No

Inclusion criteria

-Diagnosis of Cystic Fibrosis by either of the following criteria: \>60 sweat chloride test or paired deleterious DNA cystic fibrosis transmembrane conductance regulator (CFTR) mutations (Ambry genetics, Genetech or ARUP); -Pancreatic insufficient as defined by doctor's prescription of pancreatic enzymes.

Exclusion criteria

* Hospitalized for bowel obstruction or surgery in the six months prior to enrollment; * had had a pulmonary exacerbation or oral steroid use or IV antibiotics within one month of enrollment, * who had been taking either GSH or N-acetyl cysteine (NAC) within the 12 month period immediately prior to the trial, * chronically infected with Burkholderia cepacia.

Design outcomes

Primary

MeasureTime frameDescription
Weight Percentile at 3 Months3 monthsWeight Percentile at 3 months adjusted for sex and age
Height Percentile3 monthsHeight Percentile adjusted for sex and age
BMI Percentile3 monthsBody Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age
Weight Percentile6 monthsWeight percentile, adjusted for sex and age
Fecal Calprotectin6 monthsFecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome.

Secondary

MeasureTime frameDescription
Vitamin E6 monthsSerum Vitamin E levels were measured to determine if treatment affected this test.
Alanine Aminotransferase (ALT)6 MonthsALT was measured to determine if liver function was affected by treatment over the course of the study.
Frequency of Abdominal Pain6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Abdominal Pain6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Belching6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Belching6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Flatulence6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Flatulence6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Lack of Appetite6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Lack of Appetite6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Bloating6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Bloating6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Forced Vital Capacity3 monthsForced vital capacity percent predicted
Severity of Nausea6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Vomiting6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Vomiting6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Heart Burn6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Heart Burn6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Diarrhea6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Diarrhea6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of More Than 2 Bowel Movements Per Day6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of More Than 2 Bowel Movements Per Day6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Less Than 2 Bowel Movements Per Week6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Less Than 2 Bowel Movements Per Week6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Nausea6 monthsPart of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
FEV13 monthsForced expiratory volume at one second, percent predicted
Bacteriology3 monthsExpectorated sputum or throat swab
C-Reactive Protein (CRP)6 monthsCRP was measured to determine if this test fell during the course of treatment.
White Blood Cell Count6 monthsWhite blood cell count was measure at the beginning and end of the study to determine if treatment affected this test.

Countries

Italy

Participant flow

Participants by arm

ArmCount
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.
22
Placebo Oral 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.
22
Total44

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation10
Overall StudyWithdrawal by Subject11

Baseline characteristics

CharacteristicOral Reduced L-glutathionePlacebo Oral Calcium CitrateTotal
Age, Customized
15 months to 3 years
6 participants6 participants12 participants
Age, Customized
3 years to 10 years
16 participants16 participants32 participants
ALT23.2 units per liter
STANDARD_DEVIATION 9.3
22.6 units per liter
STANDARD_DEVIATION 11.4
22.9 units per liter
STANDARD_DEVIATION 10.3
Bacteriology
A. xylososidans
3 participants1 participants4 participants
Bacteriology
MRSA
0 participants1 participants1 participants
Bacteriology
Normal flora
3 participants2 participants5 participants
Bacteriology
PA
2 participants3 participants5 participants
Bacteriology
PA and S. maltophilia
1 participants0 participants1 participants
Bacteriology
PA and Staph
5 participants6 participants11 participants
Bacteriology
Staph
7 participants9 participants16 participants
Bacteriology
Staph and A. xylososidans
1 participants0 participants1 participants
Body Mass Index Percentile25.1 Percentile adjusted for age and sex
STANDARD_DEVIATION 15.9
31.1 Percentile adjusted for age and sex
STANDARD_DEVIATION 14.1
28.3 Percentile adjusted for age and sex
STANDARD_DEVIATION 15.1
C-Reactive Protein13.3 miligrams per liter
STANDARD_DEVIATION 7.7
12.1 miligrams per liter
STANDARD_DEVIATION 6.6
12.7 miligrams per liter
STANDARD_DEVIATION 7.1
Fecal Calprotectin113.2 micrograms/gram feces
STANDARD_DEVIATION 52.5
76.1 micrograms/gram feces
STANDARD_DEVIATION 32.2
94.6 micrograms/gram feces
STANDARD_DEVIATION 47
Forced Expiratory Volume at one second.63.5 Percent predicted
STANDARD_DEVIATION 4.8
71 Percent predicted
STANDARD_DEVIATION 7.8
66.9 Percent predicted
STANDARD_DEVIATION 7.3
Forced Vital Capacity81.8 Percent Predicted
STANDARD_DEVIATION 8.7
88.2 Percent Predicted
STANDARD_DEVIATION 9.6
84.7 Percent Predicted
STANDARD_DEVIATION 9.4
Frequency of Abdominal Pain
1- never
7 participants11 participants18 participants
Frequency of Abdominal Pain
2- rare
10 participants4 participants14 participants
Frequency of Abdominal Pain
3- frequently
4 participants6 participants10 participants
Frequency of Abdominal Pain
4- constantly
1 participants1 participants2 participants
Frequency of Belching
1- never
14 participants15 participants29 participants
Frequency of Belching
2- rare
3 participants3 participants6 participants
Frequency of Belching
3- frequently
5 participants4 participants9 participants
Frequency of Belching
4- constantly
0 participants0 participants0 participants
Frequency of Bloating
1- never
2 participants4 participants6 participants
Frequency of Bloating
2- rare
7 participants7 participants14 participants
Frequency of Bloating
3- frequently
12 participants10 participants22 participants
Frequency of Bloating
4- constantly
1 participants1 participants2 participants
Frequency of Diarrhea
1- never
9 participants9 participants18 participants
Frequency of Diarrhea
2- rare
9 participants11 participants20 participants
Frequency of Diarrhea
3- frequently
4 participants2 participants6 participants
Frequency of Diarrhea
4- constantly
0 participants0 participants0 participants
Frequency of Flatulence
1- never
3 participants4 participants7 participants
Frequency of Flatulence
2- rare
10 participants9 participants19 participants
Frequency of Flatulence
3- frequently
8 participants9 participants17 participants
Frequency of Flatulence
4- constantly
1 participants0 participants1 participants
Frequency of Heart Burn
1- never
17 participants18 participants35 participants
Frequency of Heart Burn
2- rare
1 participants2 participants3 participants
Frequency of Heart Burn
3- frequently
4 participants2 participants6 participants
Frequency of Heart Burn
4- constantly
0 participants0 participants0 participants
Frequency of Lack of Appetite
1- never
1 participants5 participants6 participants
Frequency of Lack of Appetite
2- rare
10 participants13 participants23 participants
Frequency of Lack of Appetite
3- frequently
8 participants4 participants12 participants
Frequency of Lack of Appetite
4- constantly
3 participants0 participants3 participants
Frequency of Less Than 2 Bowel Movements Per Week
1- never
18 participants17 participants35 participants
Frequency of Less Than 2 Bowel Movements Per Week
2- rare
0 participants2 participants2 participants
Frequency of Less Than 2 Bowel Movements Per Week
3- frequently
4 participants3 participants7 participants
Frequency of Less Than 2 Bowel Movements Per Week
4- constantly
0 participants0 participants0 participants
Frequency of More than 2 Bowel Movements Per Day
1- never
4 participants10 participants14 participants
Frequency of More than 2 Bowel Movements Per Day
2- rare
12 participants6 participants18 participants
Frequency of More than 2 Bowel Movements Per Day
3- frequently
5 participants6 participants11 participants
Frequency of More than 2 Bowel Movements Per Day
4- constantly
1 participants0 participants1 participants
Frequency of Nausea
1- never
11 participants15 participants26 participants
Frequency of Nausea
2- rare
8 participants7 participants15 participants
Frequency of Nausea
3- frequently
3 participants0 participants3 participants
Frequency of Nausea
4- constantly
0 participants0 participants0 participants
Frequency of Vomiting
1- never
16 participants18 participants34 participants
Frequency of Vomiting
2- rare
6 participants4 participants10 participants
Frequency of Vomiting
3- frequently
0 participants0 participants0 participants
Frequency of Vomiting
4- constantly
0 participants0 participants0 participants
Gene Mutations
3849+10kb/N1303k
1 participants0 participants1 participants
Gene Mutations
DelF508/3849+10KBCT
1 participants1 participants2 participants
Gene Mutations
DelF508/DelF508
4 participants5 participants9 participants
Gene Mutations
DelF508/G542X
1 participants2 participants3 participants
Gene Mutations
DelF508/G576X
0 participants1 participants1 participants
Gene Mutations
DelF508/N1303K
1 participants1 participants2 participants
Gene Mutations
DelF508/R117H
1 participants0 participants1 participants
Gene Mutations
DelF508/R347P
0 participants1 participants1 participants
Gene Mutations
DelF508/R553X
2 participants0 participants2 participants
Gene Mutations
DelF508/S489X
0 participants1 participants1 participants
Gene Mutations
G542X/G542X
0 participants1 participants1 participants
Gene Mutations
G551D/1303K
1 participants0 participants1 participants
Gene Mutations
G551D/621+1GT
1 participants0 participants1 participants
Gene Mutations
G551D/DelF508
1 participants2 participants3 participants
Gene Mutations
N1303k/G542X
0 participants2 participants2 participants
Gene Mutations
N1303K/R553X
1 participants0 participants1 participants
Gene Mutations
R117H/1466delAATT
1 participants0 participants1 participants
Gene Mutations
R117H/G542X
1 participants2 participants3 participants
Gene Mutations
R117H/R117H
0 participants1 participants1 participants
Gene Mutations
R117H/R347P
1 participants1 participants2 participants
Gene Mutations
R117H/W1282X
1 participants0 participants1 participants
Gene Mutations
W1282X/DelF508
2 participants1 participants3 participants
Gene Mutations
W1282X/R347P
1 participants0 participants1 participants
Height Percentile36.3 Percentile adjusted for weight and heigh
STANDARD_DEVIATION 14.4
39.3 Percentile adjusted for weight and heigh
STANDARD_DEVIATION 13.5
37.7 Percentile adjusted for weight and heigh
STANDARD_DEVIATION 13.9
Participants' Lipase Intake in Units Per Day130909.1 units of lipase
STANDARD_DEVIATION 54590.2
123181.8 units of lipase
STANDARD_DEVIATION 47044.7
127045.5 units of lipase
STANDARD_DEVIATION 50512.7
Region of Enrollment
Italy
22 participants22 participants44 participants
Severity of Abdominal Pain
1- absent
6 participants11 participants17 participants
Severity of Abdominal Pain
2- light
12 participants4 participants16 participants
Severity of Abdominal Pain
3- moderate
3 participants7 participants10 participants
Severity of Abdominal Pain
4- serious
1 participants0 participants1 participants
Severity of Belching
1- absent
14 participants3 participants17 participants
Severity of Belching
2- light
5 participants10 participants15 participants
Severity of Belching
3- moderate
3 participants8 participants11 participants
Severity of Belching
4- serious
0 participants1 participants1 participants
Severity of Bloating
1- absent
2 participants4 participants6 participants
Severity of Bloating
2- light
7 participants7 participants14 participants
Severity of Bloating
3- moderate
13 participants10 participants23 participants
Severity of Bloating
4- serious
0 participants1 participants1 participants
Severity of Diarrhea
1- absent
9 participants10 participants19 participants
Severity of Diarrhea
2- light
10 participants10 participants20 participants
Severity of Diarrhea
3- moderate
3 participants2 participants5 participants
Severity of Diarrhea
4- serious
0 participants0 participants0 participants
Severity of Flatulence
1- absent
3 participants4 participants7 participants
Severity of Flatulence
2- light
11 participants10 participants21 participants
Severity of Flatulence
3- moderate
8 participants8 participants16 participants
Severity of Flatulence
4- serious
0 participants0 participants0 participants
Severity of Heart Burn
1- absent
17 participants18 participants35 participants
Severity of Heart Burn
2- light
1 participants1 participants2 participants
Severity of Heart Burn
3- moderate
4 participants3 participants7 participants
Severity of Heart Burn
4- serious
0 participants0 participants0 participants
Severity of Lack of Appetite
1- absent
1 participants5 participants6 participants
Severity of Lack of Appetite
2- light
11 participants13 participants24 participants
Severity of Lack of Appetite
3- moderate
7 participants4 participants11 participants
Severity of Lack of Appetite
4- serious
3 participants0 participants3 participants
Severity of Less Than 2 Bowel Movements Per Week
1- absent
18 participants17 participants35 participants
Severity of Less Than 2 Bowel Movements Per Week
2- light
0 participants3 participants3 participants
Severity of Less Than 2 Bowel Movements Per Week
3- moderate
4 participants2 participants6 participants
Severity of Less Than 2 Bowel Movements Per Week
4- serious
0 participants0 participants0 participants
Severity of More Than 2 Bowel Movements Per Day
1- absent
4 participants10 participants14 participants
Severity of More Than 2 Bowel Movements Per Day
2- light
12 participants8 participants20 participants
Severity of More Than 2 Bowel Movements Per Day
3- moderate
5 participants4 participants9 participants
Severity of More Than 2 Bowel Movements Per Day
4- serious
1 participants0 participants1 participants
Severity of Nausea
1- absent
11 participants15 participants26 participants
Severity of Nausea
2- light
9 participants6 participants15 participants
Severity of Nausea
3- moderate
2 participants1 participants3 participants
Severity of Nausea
4- serious
0 participants0 participants0 participants
Severity of Vomiting
1- absent
16 participants18 participants34 participants
Severity of Vomiting
2- light
6 participants4 participants10 participants
Severity of Vomiting
3- moderate
0 participants0 participants0 participants
Severity of Vomiting
4- serious
0 participants0 participants0 participants
Sex: Female, Male
Female
14 Participants10 Participants24 Participants
Sex: Female, Male
Male
8 Participants12 Participants20 Participants
Sweat Chloride Test87.7 mmol/L
STANDARD_DEVIATION 15.8
85.0 mmol/L
STANDARD_DEVIATION 15.6
86.3 mmol/L
STANDARD_DEVIATION 15.6
Vitamin E7.7 micrograms per ml.
STANDARD_DEVIATION 1.6
7.5 micrograms per ml.
STANDARD_DEVIATION 1.6
7.6 micrograms per ml.
STANDARD_DEVIATION 1.6
Weight Percentile24.2 Percentile adjusted for sex and age
STANDARD_DEVIATION 13.7
33.5 Percentile adjusted for sex and age
STANDARD_DEVIATION 13.4
26.9 Percentile adjusted for sex and age
STANDARD_DEVIATION 13.6
White Blood Cell Count9.1 1000 cells/mm^3
STANDARD_DEVIATION 2
8.9 1000 cells/mm^3
STANDARD_DEVIATION 2.7
9.0 1000 cells/mm^3
STANDARD_DEVIATION 2.4

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 220 / 22
serious
Total, serious adverse events
0 / 220 / 22

Outcome results

Primary

BMI Percentile

Body Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age

Time frame: 3 months

Population: BMI percentile not available for children under 2 years of age.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneBMI Percentile37.1 Percentile adjusted for age and sexStandard Deviation 33.6
Placebo Calcium CitrateBMI Percentile47.5 Percentile adjusted for age and sexStandard Deviation 17
Primary

BMI Percentile

Body Mass Index percentile adjusted for sex and age. Not available for participants under 2 years of age.

Time frame: 6 months

Population: All old enough to have BMI percentile calculated. BMI percentile not available for children under 2 years of age

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneBMI Percentile47.5 Percentile adjusted for age and sexStandard Deviation 14
Placebo Calcium CitrateBMI Percentile36.0 Percentile adjusted for age and sexStandard Deviation 17
Primary

Fecal Calprotectin

Fecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome.

Time frame: 6 months

Population: All participants.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneFecal Calprotectin61.2 Micrograms/gram fecesStandard Deviation 26.4
Placebo Calcium CitrateFecal Calprotectin76.6 Micrograms/gram fecesStandard Deviation 30.7
Primary

Height Percentile

The subjects were measured over the course of the study to determine if treatment improved height percentile.

Time frame: 6 Months

Population: All participants.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneHeight Percentile43.3 Percentile adjusted for age and sexStandard Deviation 12.5
Placebo Calcium CitrateHeight Percentile36.5 Percentile adjusted for age and sexStandard Deviation 13.2
Primary

Height Percentile

Height Percentile adjusted for sex and age

Time frame: 3 months

Population: All participants.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneHeight Percentile39.3 Percentile adjusted for age and sexStandard Deviation 11.9
Placebo Calcium CitrateHeight Percentile38.0 Percentile adjusted for age and sexStandard Deviation 13.8
Primary

Weight Percentile

Weight percentile, adjusted for sex and age

Time frame: 6 months

Population: All participants.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneWeight Percentile43.2 Percentile adjusted for age and sexStandard Deviation 12.3
Placebo Calcium CitrateWeight Percentile31.8 Percentile adjusted for age and sexStandard Deviation 14
Primary

Weight Percentile at 3 Months

Weight Percentile at 3 months adjusted for sex and age

Time frame: 3 months

Population: All participants.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneWeight Percentile at 3 Months33.5 Weight Percentile, sex and age adjustedStandard Deviation 14.9
Placebo Calcium CitrateWeight Percentile at 3 Months31.0 Weight Percentile, sex and age adjustedStandard Deviation 13.4
Secondary

Alanine Aminotransferase (ALT)

ALT was measured to determine if liver function was affected by treatment over the course of the study.

Time frame: 6 Months

Population: All participants.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneAlanine Aminotransferase (ALT)18.1 units per literStandard Deviation 7
Placebo Calcium CitrateAlanine Aminotransferase (ALT)25.8 units per literStandard Deviation 10.9
Secondary

Bacteriology

Expectorated sputum or throat swab

Time frame: 6 Months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneBacteriologyA. xylososidans0 participants
Oral Reduced L-glutathioneBacteriologyMRSA0 participants
Oral Reduced L-glutathioneBacteriologyPA1 participants
Oral Reduced L-glutathioneBacteriologyStaph12 participants
Oral Reduced L-glutathioneBacteriologyNoraml flora6 participants
Oral Reduced L-glutathioneBacteriologyPA and S. maltophilia0 participants
Oral Reduced L-glutathioneBacteriologyPA and Staph1 participants
Oral Reduced L-glutathioneBacteriologyStaph and A. xylososidans0 participants
Oral Reduced L-glutathioneBacteriologyS. maltophilia1 participants
Oral Reduced L-glutathioneBacteriologyStrep B1 participants
Placebo Calcium CitrateBacteriologyStaph and A. xylososidans0 participants
Placebo Calcium CitrateBacteriologyA. xylososidans0 participants
Placebo Calcium CitrateBacteriologyPA and S. maltophilia0 participants
Placebo Calcium CitrateBacteriologyMRSA1 participants
Placebo Calcium CitrateBacteriologyStrep B0 participants
Placebo Calcium CitrateBacteriologyPA7 participants
Placebo Calcium CitrateBacteriologyPA and Staph5 participants
Placebo Calcium CitrateBacteriologyStaph8 participants
Placebo Calcium CitrateBacteriologyS. maltophilia1 participants
Placebo Calcium CitrateBacteriologyNoraml flora0 participants
Secondary

Bacteriology

Expectorated sputum or throat swab

Time frame: 3 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneBacteriologyMRSA0 participants
Oral Reduced L-glutathioneBacteriologyPA and S. maltophilia0 participants
Oral Reduced L-glutathioneBacteriologyA. xylososidans1 participants
Oral Reduced L-glutathioneBacteriologyPA and Staph4 participants
Oral Reduced L-glutathioneBacteriologyPA0 participants
Oral Reduced L-glutathioneBacteriologyStaph and A. xylososidans0 participants
Oral Reduced L-glutathioneBacteriologyNormal flora4 participants
Oral Reduced L-glutathioneBacteriologyS. maltophilia1 participants
Oral Reduced L-glutathioneBacteriologyStaph12 participants
Placebo Calcium CitrateBacteriologyS. maltophilia0 participants
Placebo Calcium CitrateBacteriologyStaph9 participants
Placebo Calcium CitrateBacteriologyA. xylososidans0 participants
Placebo Calcium CitrateBacteriologyMRSA0 participants
Placebo Calcium CitrateBacteriologyPA4 participants
Placebo Calcium CitrateBacteriologyNormal flora2 participants
Placebo Calcium CitrateBacteriologyPA and S. maltophilia0 participants
Placebo Calcium CitrateBacteriologyPA and Staph7 participants
Placebo Calcium CitrateBacteriologyStaph and A. xylososidans0 participants
Secondary

C-Reactive Protein (CRP)

CRP was measured to determine if this test fell during the course of treatment.

Time frame: 6 months

Population: All participants.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneC-Reactive Protein (CRP)10.9 milligrams per literStandard Deviation 5.6
Placebo Calcium CitrateC-Reactive Protein (CRP)14.7 milligrams per literStandard Deviation 6.5
Secondary

FEV1

Forced expiratory volume at one second, percent predicted

Time frame: 3 months

Population: Pulmonary function tests not performed on children under the age of 5

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneFEV173.2 Percent predictedStandard Deviation 5.6
Placebo Calcium CitrateFEV173.0 Percent predictedStandard Deviation 11.1
Secondary

FEV1

Forced expiratory volume at one second, percent predicted.

Time frame: 6 months

Population: PFT's not done on children under age of 5.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneFEV181.5 Percent predictedStandard Deviation 4.9
Placebo Calcium CitrateFEV171.6 Percent predictedStandard Deviation 8.3
Secondary

Forced Vital Capacity

Forced vital capacity percent predicted

Time frame: 3 months

Population: Pulmonary function tests not performed on children under the age of 5

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneForced Vital Capacity87.2 percent predictedStandard Deviation 7.2
Placebo Calcium CitrateForced Vital Capacity88.8 percent predictedStandard Deviation 10.3
Secondary

Forced Vital Capacity

Percent predicted of forced vital capacity.

Time frame: 6 months

Population: PFT's not done on children under age of 5.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneForced Vital Capacity92.3 Percent PredictedStandard Deviation 7.3
Placebo Calcium CitrateForced Vital Capacity83.9 Percent PredictedStandard Deviation 8.2
Secondary

Frequency of Abdominal Pain

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneFrequency of Abdominal Pain2- rare6 participants
Oral Reduced L-glutathioneFrequency of Abdominal Pain4- constantly0 participants
Oral Reduced L-glutathioneFrequency of Abdominal Pain3- frequently1 participants
Oral Reduced L-glutathioneFrequency of Abdominal PainDid Not Answer0 participants
Oral Reduced L-glutathioneFrequency of Abdominal Pain1- never15 participants
Placebo Calcium CitrateFrequency of Abdominal PainDid Not Answer0 participants
Placebo Calcium CitrateFrequency of Abdominal Pain1- never9 participants
Placebo Calcium CitrateFrequency of Abdominal Pain2- rare7 participants
Placebo Calcium CitrateFrequency of Abdominal Pain3- frequently6 participants
Placebo Calcium CitrateFrequency of Abdominal Pain4- constantly0 participants
Secondary

Frequency of Belching

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneFrequency of Belching1- never18 participants
Oral Reduced L-glutathioneFrequency of Belching4- constantly0 participants
Oral Reduced L-glutathioneFrequency of Belching3- frequently0 participants
Oral Reduced L-glutathioneFrequency of BelchingDid Not Answer0 participants
Oral Reduced L-glutathioneFrequency of Belching2- rare4 participants
Placebo Calcium CitrateFrequency of BelchingDid Not Answer0 participants
Placebo Calcium CitrateFrequency of Belching1- never11 participants
Placebo Calcium CitrateFrequency of Belching2- rare6 participants
Placebo Calcium CitrateFrequency of Belching3- frequently5 participants
Placebo Calcium CitrateFrequency of Belching4- constantly0 participants
Secondary

Frequency of Bloating

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneFrequency of Bloating2- rare14 participants
Oral Reduced L-glutathioneFrequency of Bloating4- constantly0 participants
Oral Reduced L-glutathioneFrequency of Bloating3- frequently2 participants
Oral Reduced L-glutathioneFrequency of BloatingDid Not Answer0 participants
Oral Reduced L-glutathioneFrequency of Bloating1- never6 participants
Placebo Calcium CitrateFrequency of BloatingDid Not Answer0 participants
Placebo Calcium CitrateFrequency of Bloating1- never2 participants
Placebo Calcium CitrateFrequency of Bloating2- rare9 participants
Placebo Calcium CitrateFrequency of Bloating3- frequently10 participants
Placebo Calcium CitrateFrequency of Bloating4- constantly1 participants
Secondary

Frequency of Diarrhea

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneFrequency of Diarrhea2- rare4 participants
Oral Reduced L-glutathioneFrequency of Diarrhea4- constantly0 participants
Oral Reduced L-glutathioneFrequency of Diarrhea3- frequently0 participants
Oral Reduced L-glutathioneFrequency of DiarrheaDid Not Answer0 participants
Oral Reduced L-glutathioneFrequency of Diarrhea1- never18 participants
Placebo Calcium CitrateFrequency of DiarrheaDid Not Answer0 participants
Placebo Calcium CitrateFrequency of Diarrhea1- never11 participants
Placebo Calcium CitrateFrequency of Diarrhea2- rare8 participants
Placebo Calcium CitrateFrequency of Diarrhea3- frequently3 participants
Placebo Calcium CitrateFrequency of Diarrhea4- constantly0 participants
Secondary

Frequency of Flatulence

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneFrequency of Flatulence2- rare14 participants
Oral Reduced L-glutathioneFrequency of Flatulence4- constantly0 participants
Oral Reduced L-glutathioneFrequency of Flatulence3- frequently1 participants
Oral Reduced L-glutathioneFrequency of FlatulenceDid Not Answer0 participants
Oral Reduced L-glutathioneFrequency of Flatulence1- never7 participants
Placebo Calcium CitrateFrequency of FlatulenceDid Not Answer0 participants
Placebo Calcium CitrateFrequency of Flatulence1- never3 participants
Placebo Calcium CitrateFrequency of Flatulence2- rare10 participants
Placebo Calcium CitrateFrequency of Flatulence3- frequently9 participants
Placebo Calcium CitrateFrequency of Flatulence4- constantly0 participants
Secondary

Frequency of Heart Burn

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneFrequency of Heart Burn2- rare5 participants
Oral Reduced L-glutathioneFrequency of Heart Burn4- constantly0 participants
Oral Reduced L-glutathioneFrequency of Heart Burn3- frequently0 participants
Oral Reduced L-glutathioneFrequency of Heart BurnDid Not Answer0 participants
Oral Reduced L-glutathioneFrequency of Heart Burn1- never17 participants
Placebo Calcium CitrateFrequency of Heart BurnDid Not Answer0 participants
Placebo Calcium CitrateFrequency of Heart Burn1- never18 participants
Placebo Calcium CitrateFrequency of Heart Burn2- rare3 participants
Placebo Calcium CitrateFrequency of Heart Burn3- frequently1 participants
Placebo Calcium CitrateFrequency of Heart Burn4- constantly0 participants
Secondary

Frequency of Lack of Appetite

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneFrequency of Lack of Appetite2- rare11 participants
Oral Reduced L-glutathioneFrequency of Lack of Appetite4- constantly0 participants
Oral Reduced L-glutathioneFrequency of Lack of Appetite3- frequently0 participants
Oral Reduced L-glutathioneFrequency of Lack of AppetiteDid Not Answer0 participants
Oral Reduced L-glutathioneFrequency of Lack of Appetite1- never11 participants
Placebo Calcium CitrateFrequency of Lack of AppetiteDid Not Answer0 participants
Placebo Calcium CitrateFrequency of Lack of Appetite1- never4 participants
Placebo Calcium CitrateFrequency of Lack of Appetite2- rare14 participants
Placebo Calcium CitrateFrequency of Lack of Appetite3- frequently4 participants
Placebo Calcium CitrateFrequency of Lack of Appetite4- constantly0 participants
Secondary

Frequency of Less Than 2 Bowel Movements Per Week

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneFrequency of Less Than 2 Bowel Movements Per Week2- rare3 participants
Oral Reduced L-glutathioneFrequency of Less Than 2 Bowel Movements Per Week4- constantly0 participants
Oral Reduced L-glutathioneFrequency of Less Than 2 Bowel Movements Per Week3- frequently0 participants
Oral Reduced L-glutathioneFrequency of Less Than 2 Bowel Movements Per WeekDid Not Answer0 participants
Oral Reduced L-glutathioneFrequency of Less Than 2 Bowel Movements Per Week1- never19 participants
Placebo Calcium CitrateFrequency of Less Than 2 Bowel Movements Per WeekDid Not Answer0 participants
Placebo Calcium CitrateFrequency of Less Than 2 Bowel Movements Per Week1- never16 participants
Placebo Calcium CitrateFrequency of Less Than 2 Bowel Movements Per Week2- rare5 participants
Placebo Calcium CitrateFrequency of Less Than 2 Bowel Movements Per Week3- frequently1 participants
Placebo Calcium CitrateFrequency of Less Than 2 Bowel Movements Per Week4- constantly0 participants
Secondary

Frequency of More Than 2 Bowel Movements Per Day

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneFrequency of More Than 2 Bowel Movements Per Day2- rare6 participants
Oral Reduced L-glutathioneFrequency of More Than 2 Bowel Movements Per Day4- constantly0 participants
Oral Reduced L-glutathioneFrequency of More Than 2 Bowel Movements Per Day3- frequently1 participants
Oral Reduced L-glutathioneFrequency of More Than 2 Bowel Movements Per DayDid Not Answer0 participants
Oral Reduced L-glutathioneFrequency of More Than 2 Bowel Movements Per Day1- never15 participants
Placebo Calcium CitrateFrequency of More Than 2 Bowel Movements Per DayDid Not Answer0 participants
Placebo Calcium CitrateFrequency of More Than 2 Bowel Movements Per Day1- never12 participants
Placebo Calcium CitrateFrequency of More Than 2 Bowel Movements Per Day2- rare3 participants
Placebo Calcium CitrateFrequency of More Than 2 Bowel Movements Per Day3- frequently7 participants
Placebo Calcium CitrateFrequency of More Than 2 Bowel Movements Per Day4- constantly0 participants
Secondary

Frequency of Nausea

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneFrequency of Nausea2- rare8 participants
Oral Reduced L-glutathioneFrequency of Nausea4- constantly0 participants
Oral Reduced L-glutathioneFrequency of Nausea3- frequently0 participants
Oral Reduced L-glutathioneFrequency of NauseaDid Not Answer0 participants
Oral Reduced L-glutathioneFrequency of Nausea1- never14 participants
Placebo Calcium CitrateFrequency of NauseaDid Not Answer0 participants
Placebo Calcium CitrateFrequency of Nausea1- never14 participants
Placebo Calcium CitrateFrequency of Nausea2- rare7 participants
Placebo Calcium CitrateFrequency of Nausea3- frequently1 participants
Placebo Calcium CitrateFrequency of Nausea4- constantly0 participants
Secondary

Frequency of Vomiting

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneFrequency of Vomiting2- rare1 participants
Oral Reduced L-glutathioneFrequency of Vomiting4- constantly0 participants
Oral Reduced L-glutathioneFrequency of Vomiting3- frequently0 participants
Oral Reduced L-glutathioneFrequency of VomitingDid Not Answer0 participants
Oral Reduced L-glutathioneFrequency of Vomiting1- never21 participants
Placebo Calcium CitrateFrequency of VomitingDid Not Answer0 participants
Placebo Calcium CitrateFrequency of Vomiting1- never15 participants
Placebo Calcium CitrateFrequency of Vomiting2- rare7 participants
Placebo Calcium CitrateFrequency of Vomiting3- frequently0 participants
Placebo Calcium CitrateFrequency of Vomiting4- constantly0 participants
Secondary

Severity of Abdominal Pain

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneSeverity of Abdominal Pain2- light7 participants
Oral Reduced L-glutathioneSeverity of Abdominal Pain4- serious0 participants
Oral Reduced L-glutathioneSeverity of Abdominal Pain3- moderate0 participants
Oral Reduced L-glutathioneSeverity of Abdominal PainDid Not Answer1 participants
Oral Reduced L-glutathioneSeverity of Abdominal Pain1- absent14 participants
Placebo Calcium CitrateSeverity of Abdominal PainDid Not Answer1 participants
Placebo Calcium CitrateSeverity of Abdominal Pain1- absent9 participants
Placebo Calcium CitrateSeverity of Abdominal Pain2- light9 participants
Placebo Calcium CitrateSeverity of Abdominal Pain3- moderate3 participants
Placebo Calcium CitrateSeverity of Abdominal Pain4- serious0 participants
Secondary

Severity of Belching

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneSeverity of Belching2- light3 participants
Oral Reduced L-glutathioneSeverity of Belching4- serious0 participants
Oral Reduced L-glutathioneSeverity of Belching3- moderate0 participants
Oral Reduced L-glutathioneSeverity of BelchingDid Not Answer1 participants
Oral Reduced L-glutathioneSeverity of Belching1- absent18 participants
Placebo Calcium CitrateSeverity of BelchingDid Not Answer1 participants
Placebo Calcium CitrateSeverity of Belching1- absent11 participants
Placebo Calcium CitrateSeverity of Belching2- light6 participants
Placebo Calcium CitrateSeverity of Belching3- moderate4 participants
Placebo Calcium CitrateSeverity of Belching4- serious0 participants
Secondary

Severity of Bloating

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneSeverity of Bloating2- light14 participants
Oral Reduced L-glutathioneSeverity of Bloating4- serious0 participants
Oral Reduced L-glutathioneSeverity of Bloating3- moderate1 participants
Oral Reduced L-glutathioneSeverity of BloatingDid Not Answer1 participants
Oral Reduced L-glutathioneSeverity of Bloating1- absent6 participants
Placebo Calcium CitrateSeverity of BloatingDid Not Answer1 participants
Placebo Calcium CitrateSeverity of Bloating1- absent2 participants
Placebo Calcium CitrateSeverity of Bloating2- light11 participants
Placebo Calcium CitrateSeverity of Bloating3- moderate7 participants
Placebo Calcium CitrateSeverity of Bloating4- serious1 participants
Secondary

Severity of Diarrhea

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneSeverity of Diarrhea2- light4 participants
Oral Reduced L-glutathioneSeverity of Diarrhea4- serious0 participants
Oral Reduced L-glutathioneSeverity of Diarrhea3- moderate0 participants
Oral Reduced L-glutathioneSeverity of DiarrheaDid Not Answer1 participants
Oral Reduced L-glutathioneSeverity of Diarrhea1- absent17 participants
Placebo Calcium CitrateSeverity of DiarrheaDid Not Answer1 participants
Placebo Calcium CitrateSeverity of Diarrhea1- absent10 participants
Placebo Calcium CitrateSeverity of Diarrhea2- light8 participants
Placebo Calcium CitrateSeverity of Diarrhea3- moderate3 participants
Placebo Calcium CitrateSeverity of Diarrhea4- serious0 participants
Secondary

Severity of Flatulence

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneSeverity of Flatulence2- light13 participants
Oral Reduced L-glutathioneSeverity of Flatulence4- serious0 participants
Oral Reduced L-glutathioneSeverity of Flatulence3- moderate1 participants
Oral Reduced L-glutathioneSeverity of FlatulenceDid Not Answer1 participants
Oral Reduced L-glutathioneSeverity of Flatulence1- absent7 participants
Placebo Calcium CitrateSeverity of FlatulenceDid Not Answer1 participants
Placebo Calcium CitrateSeverity of Flatulence1- absent3 participants
Placebo Calcium CitrateSeverity of Flatulence2- light11 participants
Placebo Calcium CitrateSeverity of Flatulence3- moderate7 participants
Placebo Calcium CitrateSeverity of Flatulence4- serious0 participants
Secondary

Severity of Heart Burn

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneSeverity of Heart Burn2- light4 participants
Oral Reduced L-glutathioneSeverity of Heart Burn4- serious0 participants
Oral Reduced L-glutathioneSeverity of Heart Burn3- moderate0 participants
Oral Reduced L-glutathioneSeverity of Heart BurnDid Not Answer1 participants
Oral Reduced L-glutathioneSeverity of Heart Burn1- absent17 participants
Placebo Calcium CitrateSeverity of Heart BurnDid Not Answer1 participants
Placebo Calcium CitrateSeverity of Heart Burn1- absent18 participants
Placebo Calcium CitrateSeverity of Heart Burn2- light2 participants
Placebo Calcium CitrateSeverity of Heart Burn3- moderate1 participants
Placebo Calcium CitrateSeverity of Heart Burn4- serious0 participants
Secondary

Severity of Lack of Appetite

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneSeverity of Lack of Appetite2- light10 participants
Oral Reduced L-glutathioneSeverity of Lack of Appetite4- serious0 participants
Oral Reduced L-glutathioneSeverity of Lack of Appetite3- moderate0 participants
Oral Reduced L-glutathioneSeverity of Lack of AppetiteDid Not Answer1 participants
Oral Reduced L-glutathioneSeverity of Lack of Appetite1- absent11 participants
Placebo Calcium CitrateSeverity of Lack of AppetiteDid Not Answer1 participants
Placebo Calcium CitrateSeverity of Lack of Appetite1- absent3 participants
Placebo Calcium CitrateSeverity of Lack of Appetite2- light14 participants
Placebo Calcium CitrateSeverity of Lack of Appetite3- moderate4 participants
Placebo Calcium CitrateSeverity of Lack of Appetite4- serious0 participants
Secondary

Severity of Less Than 2 Bowel Movements Per Week

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneSeverity of Less Than 2 Bowel Movements Per Week1- absent17 participants
Oral Reduced L-glutathioneSeverity of Less Than 2 Bowel Movements Per Week4- serious0 participants
Oral Reduced L-glutathioneSeverity of Less Than 2 Bowel Movements Per Week2- light4 participants
Oral Reduced L-glutathioneSeverity of Less Than 2 Bowel Movements Per Week3- moderate0 participants
Oral Reduced L-glutathioneSeverity of Less Than 2 Bowel Movements Per WeekDid Not Answer1 participants
Placebo Calcium CitrateSeverity of Less Than 2 Bowel Movements Per Week3- moderate2 participants
Placebo Calcium CitrateSeverity of Less Than 2 Bowel Movements Per Week1- absent15 participants
Placebo Calcium CitrateSeverity of Less Than 2 Bowel Movements Per Week2- light4 participants
Placebo Calcium CitrateSeverity of Less Than 2 Bowel Movements Per Week4- serious0 participants
Placebo Calcium CitrateSeverity of Less Than 2 Bowel Movements Per WeekDid Not Answer1 participants
Secondary

Severity of More Than 2 Bowel Movements Per Day

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneSeverity of More Than 2 Bowel Movements Per Day2- light7 participants
Oral Reduced L-glutathioneSeverity of More Than 2 Bowel Movements Per Day4- serious0 participants
Oral Reduced L-glutathioneSeverity of More Than 2 Bowel Movements Per Day3- moderate0 participants
Oral Reduced L-glutathioneSeverity of More Than 2 Bowel Movements Per DayDid Not Answer1 participants
Oral Reduced L-glutathioneSeverity of More Than 2 Bowel Movements Per Day1- absent14 participants
Placebo Calcium CitrateSeverity of More Than 2 Bowel Movements Per DayDid Not Answer1 participants
Placebo Calcium CitrateSeverity of More Than 2 Bowel Movements Per Day1- absent12 participants
Placebo Calcium CitrateSeverity of More Than 2 Bowel Movements Per Day2- light4 participants
Placebo Calcium CitrateSeverity of More Than 2 Bowel Movements Per Day3- moderate5 participants
Placebo Calcium CitrateSeverity of More Than 2 Bowel Movements Per Day4- serious0 participants
Secondary

Severity of Nausea

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneSeverity of Nausea1- absent13 participants
Oral Reduced L-glutathioneSeverity of Nausea3- moderate0 participants
Oral Reduced L-glutathioneSeverity of Nausea4- serious0 participants
Oral Reduced L-glutathioneSeverity of NauseaDid Not Answer1 participants
Oral Reduced L-glutathioneSeverity of Nausea2- light8 participants
Placebo Calcium CitrateSeverity of NauseaDid Not Answer1 participants
Placebo Calcium CitrateSeverity of Nausea1- absent13 participants
Placebo Calcium CitrateSeverity of Nausea2- light7 participants
Placebo Calcium CitrateSeverity of Nausea4- serious0 participants
Placebo Calcium CitrateSeverity of Nausea3- moderate1 participants
Secondary

Severity of Vomiting

Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Time frame: 6 months

ArmMeasureGroupValue (NUMBER)
Oral Reduced L-glutathioneSeverity of Vomiting2- light1 participants
Oral Reduced L-glutathioneSeverity of Vomiting4- serious0 participants
Oral Reduced L-glutathioneSeverity of Vomiting3- moderate0 participants
Oral Reduced L-glutathioneSeverity of VomitingDid Not Answer1 participants
Oral Reduced L-glutathioneSeverity of Vomiting1- absent20 participants
Placebo Calcium CitrateSeverity of VomitingDid Not Answer1 participants
Placebo Calcium CitrateSeverity of Vomiting1- absent14 participants
Placebo Calcium CitrateSeverity of Vomiting2- light7 participants
Placebo Calcium CitrateSeverity of Vomiting3- moderate0 participants
Placebo Calcium CitrateSeverity of Vomiting4- serious0 participants
Secondary

Vitamin E

Serum Vitamin E levels were measured to determine if treatment affected this test.

Time frame: 6 months

Population: All participants.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneVitamin E8.6 milligrams per literStandard Deviation 1.6
Placebo Calcium CitrateVitamin E6.8 milligrams per literStandard Deviation 1.4
Secondary

White Blood Cell Count

White blood cell count was measure at the beginning and end of the study to determine if treatment affected this test.

Time frame: 6 months

Population: All participants.

ArmMeasureValue (MEAN)Dispersion
Oral Reduced L-glutathioneWhite Blood Cell Count8.4 1000 cells/mm^3Standard Deviation 1.5
Placebo Calcium CitrateWhite Blood Cell Count9.5 1000 cells/mm^3Standard Deviation 2.4

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026