N/A N=47 Randomized Quadruple-blind Treatment

Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients

Cystic Fibrosis

Bottom Line

View on ClinicalTrials.gov: NCT02029521 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Weight Percentile at 3 Months — 33.5; 31.0 Weight Percentile, sex and age adjusted

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Oral reduced l-glutathione (Dietary_supplement); Placebo (Dietary_supplement)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Clark Bishop
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Weight Percentile at 3 Months	33.5; 31.0	—
PRIMARY Height Percentile	43.3; 36.5	—
PRIMARY BMI Percentile	47.5; 36.0	—
PRIMARY BMI Percentile	47.5; 36.0	—
PRIMARY Weight Percentile	43.2; 31.8	—
PRIMARY Height Percentile	43.3; 36.5	—
PRIMARY Fecal Calprotectin	61.2; 76.6	—
SECONDARY Forced Vital Capacity	92.3; 83.9	—
SECONDARY FEV1	81.5; 71.6	—
SECONDARY Bacteriology	0; 0; 0; 1; 1; 7	—
SECONDARY Forced Vital Capacity	92.3; 83.9	—
SECONDARY FEV1	81.5; 71.6	—
SECONDARY C-Reactive Protein (CRP)	10.9; 14.7	—
SECONDARY White Blood Cell Count	8.4; 9.5	—
SECONDARY Vitamin E	8.6; 6.8	—
SECONDARY Alanine Aminotransferase (ALT)	18.1; 25.8	—
SECONDARY Bacteriology	0; 0; 0; 1; 1; 7	—
SECONDARY Frequency of Abdominal Pain	15; 9; 6; 7; 1; 6	—
SECONDARY Severity of Abdominal Pain	14; 9; 7; 9; 0; 3	—
SECONDARY Frequency of Belching	18; 11; 4; 6; 0; 5	—
SECONDARY Severity of Belching	18; 11; 3; 6; 0; 4	—
SECONDARY Frequency of Flatulence	7; 3; 14; 10; 1; 9	—
SECONDARY Severity of Flatulence	7; 3; 13; 11; 1; 7	—
SECONDARY Frequency of Lack of Appetite	11; 4; 11; 14; 0; 4	—
SECONDARY Severity of Lack of Appetite	11; 3; 10; 14; 0; 4	—
SECONDARY Frequency of Bloating	6; 2; 14; 9; 2; 10	—
SECONDARY Severity of Bloating	6; 2; 14; 11; 1; 7	—
SECONDARY Frequency of Nausea	14; 14; 8; 7; 0; 1	—
SECONDARY Severity of Nausea	13; 13; 8; 7; 0; 1	—
SECONDARY Frequency of Vomiting	21; 15; 1; 7; 0; 0	—
SECONDARY Severity of Vomiting	20; 14; 1; 7; 0; 0	—
SECONDARY Frequency of Heart Burn	17; 18; 5; 3; 0; 1	—
SECONDARY Severity of Heart Burn	17; 18; 4; 2; 0; 1	—
SECONDARY Frequency of Diarrhea	18; 11; 4; 8; 0; 3	—
SECONDARY Severity of Diarrhea	17; 10; 4; 8; 0; 3	—
SECONDARY Frequency of More Than 2 Bowel Movements Per Day	15; 12; 6; 3; 1; 7	—
SECONDARY Severity of More Than 2 Bowel Movements Per Day	14; 12; 7; 4; 0; 5	—
SECONDARY Frequency of Less Than 2 Bowel Movements Per Week	19; 16; 3; 5; 0; 1	—
SECONDARY Severity of Less Than 2 Bowel Movements Per Week	17; 15; 4; 4; 0; 2	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02029521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.