The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03020719
• Date of registration: 11/01/2017
• Prospective Registration: Yes
• Primary sponsor: University of Minnesota
• Public title: The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis GROW
• Scientific title: A Multi Center Placebo Controlled Double Blind Randomized Study Evaluating the Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis
• Date of first enrolment: June 14, 2017
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03020719
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Sarah J Schwarzenberg, MD
• Affiliation: University of Minnesota

• Name: Molly Bozic, MD
• Affiliation: Indiana University School of Medicine Riley Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female = 2 and < 11 years of age at Visit 1

2. Documentation of a CF diagnosis as evidenced by the following criteria: Sweat chloride
= 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) AND Two
well-characterized mutations in the cystic fibrosis transmembrane conductive regulator
(CFTR) gene

3. Weight-for-age between the 10th and 50th percentiles at Screening (Visit 1) (using the
Center for Disease Control (CDC) reference equations)

4. Current chronic use, greater than 8 weeks before Day 0, of pancreatic enzyme
replacement therapy (PERT) for management of pancreatic insufficiency

5. Written informed consent (and assent when applicable) obtained from subject or
subject's legal representative and ability to comply with the requirements of the
study

6. Clinically stable with no significant changes in health status within 2 weeks prior to
Day 0

Exclusion Criteria:

- 1. Intestinal obstruction or gastrointestinal surgery within the 6 months prior to Day
0 2. History of diabetes, Crohn's disease, celiac disease, or bowel resection 3. Use
of either oral or inhaled GSH or N-acetyl cysteine within the 4 months prior to
Screening (Visit 1) 4. Known hypersensitivity to oral glutathione or lactose 5.
Initiation of any new chronic therapy (e.g., ibuprofen, hypertonic saline,
azithromycin, Pulmozyme, Cayston TOBI Kalydeco,Orkambi, Proton Pump Inhibitor,
Histamine H-2 Blocker [PPI/H2-blocker], Miralax® , PERT, dietary supplementation,
probiotics) within the 4 weeks prior to Day 0 6. Changes in the amount of proprietary
dietary supplement formulas (e.g., Scandishakes, Boost, Pediasure, or homemade
formula) given (oral or gastrostomy tube) within the 4 weeks prior to Day 0 7. Use of
antibiotics (oral, IV, or inhaled) for acute symptoms within the 2 weeks prior to Day
0 8. Use of oral steroids within the 4 weeks prior to Day 0 9. Active treatment for
nontuberculous mycobacteria (NTM) at Day 0 10. Active treatment for allergic
bronchopulmonary aspergillosis (ABPA) at Day 0 11. Administration of any
investigational drug within the 30 days prior to Day 0 12. Sibling who received study
drug as part of this study 13. Presence of a condition or abnormality that in the
opinion of the investigator would compromise the safety of the patient or the quality
of the data



Age minimum: 2 Years
Age maximum: 11 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Oral Glutathione

Drug: Placebo

Primary Outcome(s)

Change in Weight-for-age Z-score [Time Frame: Baseline to 24 weeks]

Secondary Outcome(s)

Change in BMI-for-age Z-score [Time Frame: Baseline to 24 weeks]

Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline to 24 weeks]

Change in Fecal Calprotectin [Time Frame: Baseline to 24 weeks]

Change in Height-for-age Z-score [Time Frame: Baseline to 24 weeks]

Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline to 24 weeks]

Change in High-sensitivity C-reactive Protein (Hs-CRP) [Time Frame: Baseline to 24 weeks]

Secondary ID(s)

GROW-IP-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation

Results

• Results available: Yes
• Date Posted: 09/01/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03020719