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Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients

NCT02029521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2016-02-08

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Placebo

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 & Collaborators

  • Clark Bishop

    lead OTHER

Principal Investigators

  • Clark T Bishop, MD · Intermountain Health Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-03-31
Completion
2012-07-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02029521 on ClinicalTrials.gov