Primary outcomeMean· Baseline to 24 weeks
Change in Weight-for-age Z-score
| Group | Value (Z-score) |
|---|---|
| Oral Glutathione | -0.018 |
| Placebo | 0.045 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataThe Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis
Short name GROW
NCTNCT03020719 (opens ClinicalTrials.gov in a new tab)Other idGROW-IP-16
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 60 participants (actual)
- Sponsor
- University of Minnesota · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 14 Jun 2017
- Primary completion
- 12 Dec 2018
- Completion
- 12 Dec 2018
- First posted
- 13 Jan 2017 (estimated)
- Last update posted
- 9 Jan 2020
- Conditions
- Cystic Fibrosis
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201720182019
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Oral GlutathioneDrug
- PlaceboDrug
Arms2
Experimental
Oral Glutathione
Oral Glutathione oral powder at 65mg/kg/day
Placebo comparator
Placebo
Placebo oral powder at 65mg/kg/day
Primary outcomes1
Outcomes the sponsor listed as primary.
Change in Weight-for-age Z-score
Time frame · Baseline to 24 weeks
Registry description
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 outcomes(6)
Change in Height-for-age Z-score
Time frame · Baseline to 24 weeks
Registry description
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.
Change in BMI-for-age Z-score
Time frame · Baseline to 24 weeks
Registry description
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.
Change in Fecal Calprotectin
Time frame · Baseline to 24 weeks
Registry description
Difference between the oral glutathione and placebo groups in the 24-week change from baseline in fecal calprotectin.
Change in High-sensitivity C-reactive Protein (Hs-CRP)
Time frame · Baseline to 24 weeks
Registry description
Difference between the oral glutathione and placebo groups in the 24-week change from baseline in hs-CRP.
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame · Baseline to 24 weeks
Registry description
The number and percentage of participants with at least one event over the 24 week follow-up period.
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame · Baseline to 24 weeks
Registry description
Rate is defined as the number of events per participant follow-up month.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeMean· Baseline to 24 weeks
Change in Height-for-age Z-score
| Group | Value (Z-score) | Spread |
|---|---|---|
| Oral Glutathione | -0.04 | 0.21 |
| Placebo | 0.03 | 0.16 |
Secondary outcomeMean· Baseline to 24 weeks
Change in BMI-for-age Z-score
| Group | Value (Z-score) | Spread |
|---|---|---|
| Oral Glutathione | -0.01 | 0.48 |
| Placebo | 0.04 | 0.44 |
Secondary outcomeMean· Baseline to 24 weeks
Change in Fecal Calprotectin
| Group | Value (log base 10 transformation of ug/g) | Spread |
|---|---|---|
| Oral Glutathione | 0.05 | 0.55 |
| Placebo | -0.05 | 0.53 |
Secondary outcomeMean· Baseline to 24 weeks
Change in High-sensitivity C-reactive Protein (Hs-CRP)
| Group | Value (mg/L) | Spread |
|---|---|---|
| Oral Glutathione | -0.45 | 3.4 |
| Placebo | -0.04 | 1.6 |
Secondary outcomeCount of participants· Baseline to 24 weeks
Adverse Events (AEs) and Serious Adverse Events (SAEs)
| Group | Value (Participants) |
|---|---|
| Oral Glutathione | 29 |
| Placebo | 29 |
Secondary outcomeNumber· Baseline to 24 weeks
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
| Group | Value (number of events/total follow-up months) |
|---|---|
| Oral Glutathione | 0.89 |
| Placebo | 0.74 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Oral GlutathioneOral Glutathione oral powder at 65mg/kg/day Oral Glutathione: Oral Glutathione oral powder | 0 / 30 | 1 / 30 | 29 / 30 |
| PlaceboPlacebo oral powder at 65mg/kg/day Placebo: Placebo oral powder | 0 / 30 | 5 / 30 | 29 / 30 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
More studies
1 study on this page
Indexing hint: Randomized controlled trial · 2020
Oral Glutathione and Growth in Cystic Fibrosis: A Multicenter, Randomized, Placebo-controlled, Double-blind Trial.
Bozic et al. 2020Journal of pediatric gastroenterology and nutritioncited by 8
PMID 32960827PMC8220910DOI 10.1097/mpg.0000000000002948PUB-32960827
Rights unknown
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 2 Years up to 11 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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