Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients

NCT02029521 | Completed Results

• 1 other identifier: FIMP/clin.stud/2010/1.
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; growth Failure; glutathione

Outcome Measures

Primary Outcomes (7)

• Weight Percentile at 3 Months

  Weight Percentile at 3 months adjusted for sex and age

  3 months

• Height Percentile

  Height Percentile adjusted for sex and age

  3 months

• BMI Percentile

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

  3 months

• BMI Percentile

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

  6 months

• Weight Percentile

  Weight percentile, adjusted for sex and age

  6 months

• Height Percentile

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

  6 Months

• Fecal Calprotectin

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

  6 months

Secondary Outcomes (32)

• Forced Vital Capacity

  3 months

• FEV1

  3 months

• Bacteriology

  3 months

• Forced Vital Capacity

  6 months

• FEV1

  6 months

Study Arms (2)

Oral reduced l-glutathione

EXPERIMENTAL

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.

Dietary Supplement: Oral reduced l-glutathione

Placebo Calcium Citrate

PLACEBO COMPARATOR

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

Interventions

Oral reduced l-glutathione DIETARY_SUPPLEMENT

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.

Oral reduced l-glutathione

Placebo DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Age: 18 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clark Bishop: lead

Study Sites (1)

Unknown Facility

Turin, Italy

Location

MeSH Terms

Conditions

Cystic Fibrosis; Failure to Thrive

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This trial was limited to one site. The number was relatively small. Since PFT's were not done on children under the age of 5, there is even smaller number of participants contributing PFT data.

Results Point of Contact

• Title: Clark Bishop
• Organization: Intermountain Healthcare

clark.bishop@imail.org

385 224 7343

Study Officials

• Clark T Bishop, MD

  Intermountain Health Care

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co investigator

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 8, 2014
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 8, 2016
• Results First Posted: August 21, 2014

Record last verified: 2016-01

Locations

IT (1)