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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03020719
Recruitment Status : Completed
First Posted : January 13, 2017
Results First Posted : January 9, 2020
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
University of Minnesota

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

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018

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. Change in Weight-for-age Z-score [ Time Frame: Baseline to 24 weeks ]
    Difference between the oral glutathione and placebo groups in the 24-week change from baseline in weight-for-age Z-score. Weight-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.


Secondary Outcome Measures :
  1. Change in Height-for-age Z-score [ Time Frame: Baseline to 24 weeks ]
    Difference between the oral glutathione and placebo groups in the 24-week change from baseline in height-for-age Z-score. Height-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

  2. Change in BMI-for-age Z-score [ Time Frame: Baseline to 24 weeks ]
    Difference between the oral glutathione and placebo groups in the 24-week change from baseline in BMI-for-age Z-score. BMI-for-age Z-scores are derived from the 2000 Centers for Disease Control and Prevention growth charts for U.S. children. The reference population in these growth charts is children surveyed by the National Center for Health Statistics from 1963-65 to 1988-94. The Z-score indicates the number of standard deviations away from the mean of the reference population. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean.

  3. Change in Fecal Calprotectin [ Time Frame: Baseline to 24 weeks ]
    Difference between the oral glutathione and placebo groups in the 24-week change from baseline in fecal calprotectin.

  4. Change in High-sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: Baseline to 24 weeks ]
    Difference between the oral glutathione and placebo groups in the 24-week change from baseline in hs-CRP.

  5. Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to 24 weeks ]
    The number and percentage of participants with at least one event over the 24 week follow-up period.

  6. Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to 24 weeks ]
    Rate is defined as the number of events per participant follow-up month.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Show Show 18 study locations
Sponsors and Collaborators
University of Minnesota
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: Sarah J Schwarzenberg, MD University of Minnesota
Principal Investigator: Molly Bozic, MD Indiana University School of Medicine Riley Hospital
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Statistical Analysis Plan  [PDF] November 22, 2017
Study Protocol  [PDF] September 12, 2017

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03020719    
Other Study ID Numbers: GROW-IP-16
First Posted: January 13, 2017    Key Record Dates
Results First Posted: January 9, 2020
Last Update Posted: January 9, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Growth Parameters
Cystic Fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases