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

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ClinicalTrials.gov Identifier: NCT03020719
Recruitment Status : Active, not recruiting
First Posted : January 13, 2017
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The purpose of this randomized, placebo-controlled (Phase II) study will be to further evaluate the effects of oral glutathione on growth in children with CF.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Oral Glutathione Drug: Placebo Phase 2

Detailed Description:
a prospective, multi-center, randomized, placebocontrolled, double-blind, Phase II clinical trial. Approximately sixty pancreatic insufficient (PI) subjects with CF who are ≥ 2 and < 11 years of age, will be enrolled to receive either L-Glutathione Reduced (GSH) or placebo given orally (tid) for 24 weeks. Each subject will be seen for four study visits: Visit 1 (Screening), Visit 2 (Baseline/Randomization, Day 0), Visit 3 (Week 12) and Visit 4 (Week 24). At Visit 2, subjects will be randomized to receive either active treatment or placebo. Visit 1 and 2 may be combined if subject meets eligibility requirements and a fecal specimen is collected prior to dosing. Safety and clinical outcomes will be assessed throughout the study. Assessment of inflammatory and other bio-markers in blood and fecal specimens will be performed at Visits 2 and 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: A Multi Center Placebo Controlled Double Blind Randomized Study Evaluating the Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Glutathione

Arm Intervention/treatment
Experimental: Oral Glutathione
Oral Glutathione oral powder at 65mg/kg/day
Drug: Oral Glutathione
Oral Glutathione oral powder
Other Name: GSH

Placebo Comparator: Placebo
Placebo oral powder at 65mg/kg/day
Drug: Placebo
Placebo oral powder
Other Name: Inactive powder




Primary Outcome Measures :
  1. investigate the effect of 24 weeks of treatment with oral glutathione on change in weight-for-age z-scores [ Time Frame: Baseline to 24 weeks ]
    Z-score (or SD-score) = (observed value - median value of the reference population) / standard deviation value of reference population



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020719


Locations
United States, Colorado
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Connecticut Childrens Medical Center
Hartford, Connecticut, United States, 06107
United States, Florida
Nemours Childrens Clinic
Jacksonville, Florida, United States, 32207
Nemours Children's Clinic
Pensacola, Florida, United States, 32504
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30324
United States, Indiana
Riley Children's Hospital
Indianapolis, Indiana, United States, 46202
United States, Michigan
Childrens Hospital of Michigan
Detroit, Michigan, United States, 48201
Helen DeVos Women and Childrens Center
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55414
United States, Missouri
The Childrens Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, New York
Women and Childrens Hospital of Buffalo
Buffalo, New York, United States, 14222
Childrens Hospital of New York/Columbia University Medical Center
New York, New York, United States, 10032
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Vermont
The University of Vermont Inc.
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Childrens Hospital of Milwaukee
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Cystic Fibrosis Foundation Therapeutics
Investigators
Principal Investigator: Sarah J Schwarzenberg, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Molly Bozic, MD Indiana University School of Medicine Riley Hospital

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03020719     History of Changes
Other Study ID Numbers: GROW-IP-16
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Growth Parameters
Cystic Fibrosis

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases