Trial · Interventional

CompletedNot applicableResults postedRegistry data

Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients

NCTNCT02029521Other idFIMP/clin.stud/2010/1.

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 47 participants (actual)
Sponsor: Clark Bishop · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Italy
Start: Mar 2011
Primary completion: Mar 2012
Completion: Jul 2012
First posted: 8 Jan 2014 (estimated)
Last update posted: 8 Feb 2016 (estimated)
Conditions: Cystic Fibrosis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201120122013

N/A
Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients
NCT02029521
Mar 2011 to Jul 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Oral reduced l-glutathioneDietary supplement
PlaceboDietary supplement

Arms2

Experimental
Oral reduced l-glutathione
The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.
Placebo comparator
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.

Primary outcomes7

Outcomes the sponsor listed as primary.

Weight Percentile at 3 Months
Time frame · 3 months
Registry description
Weight Percentile at 3 months adjusted for sex and age
Height Percentile
Time frame · 3 months
Registry description
Height Percentile adjusted for sex and age
BMI Percentile
Time frame · 3 months
Registry description
Body Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age
BMI Percentile
Time frame · 6 months
Registry description
Body Mass Index percentile adjusted for sex and age. Not available for participants under 2 years of age.
Weight Percentile
Time frame · 6 months
Registry description
Weight percentile, adjusted for sex and age
Height Percentile
Time frame · 6 Months
Registry description
The subjects were measured over the course of the study to determine if treatment improved height percentile.
Fecal Calprotectin
Time frame · 6 months
Registry description
Fecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome.

Secondary outcomes(20)

Forced Vital Capacity
Time frame · 3 months
Registry description
Forced vital capacity percent predicted
FEV1
Time frame · 3 months
Registry description
Forced expiratory volume at one second, percent predicted
Bacteriology
Time frame · 3 months
Registry description
Expectorated sputum or throat swab
Forced Vital Capacity
Time frame · 6 months
Registry description
Percent predicted of forced vital capacity.
FEV1
Time frame · 6 months
Registry description
Forced expiratory volume at one second, percent predicted.
C-Reactive Protein (CRP)
Time frame · 6 months
Registry description
CRP was measured to determine if this test fell during the course of treatment.
White Blood Cell Count
Time frame · 6 months
Registry description
White blood cell count was measure at the beginning and end of the study to determine if treatment affected this test.
Vitamin E
Time frame · 6 months
Registry description
Serum Vitamin E levels were measured to determine if treatment affected this test.
Alanine Aminotransferase (ALT)
Time frame · 6 Months
Registry description
ALT was measured to determine if liver function was affected by treatment over the course of the study.
Bacteriology
Time frame · 6 Months
Registry description
Expectorated sputum or throat swab
Frequency of Abdominal Pain
Time frame · 6 months
Registry description
Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Abdominal Pain
Time frame · 6 months
Registry description
Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Belching
Time frame · 6 months
Registry description
Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Belching
Time frame · 6 months
Registry description
Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Flatulence
Time frame · 6 months
Registry description
Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Flatulence
Time frame · 6 months
Registry description
Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Lack of Appetite
Time frame · 6 months
Registry description
Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Lack of Appetite
Time frame · 6 months
Registry description
Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe
Frequency of Bloating
Time frame · 6 months
Registry description
Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent
Severity of Bloating
Time frame · 6 months
Registry description
Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 3 months

Weight Percentile at 3 Months

Group	Value (Weight Percentile, sex and age adjusted)	Spread
Oral Reduced L-glutathione	33.5	14.9
Placebo Calcium Citrate	31.0	13.4

Primary outcomeMean· 3 months

Height Percentile

Group	Value (Percentile adjusted for age and sex)	Spread
Oral Reduced L-glutathione	39.3	11.9
Placebo Calcium Citrate	38.0	13.8

Primary outcomeMean· 3 months

BMI Percentile

Group	Value (Percentile adjusted for age and sex)	Spread
Oral Reduced L-glutathione	37.1	33.6
Placebo Calcium Citrate	47.5	17.0

Secondary and other outcome results(5)

Secondary outcomeMean· 3 months

Forced Vital Capacity

Group	Value (percent predicted)	Spread
Oral Reduced L-glutathione	87.2	7.2
Placebo Calcium Citrate	88.8	10.3

Secondary outcomeMean· 3 months

FEV1

Group	Value (Percent predicted)	Spread
Oral Reduced L-glutathione	73.2	5.6
Placebo Calcium Citrate	73.0	11.1

Secondary outcomeNumber· 3 months

Bacteriology

Group	Value (participants)
Oral Reduced L-glutathione	1
Placebo Oral Calcium Citrate	0

Secondary outcomeMean· 6 months

Forced Vital Capacity

Group	Value (Percent Predicted)	Spread
Oral Reduced L-glutathione	92.3	7.3
Placebo Calcium Citrate	83.9	8.2

Secondary outcomeMean· 6 months

FEV1

Group	Value (Percent predicted)	Spread
Oral Reduced L-glutathione	81.5	4.9
Placebo Calcium Citrate	71.6	8.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Oral Reduced L-glutathioneThe 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.	–	0 / 22	0 / 22
Placebo Calcium CitrateThe 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.	–	0 / 22	0 / 22

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Months up to 10 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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