MalnutritionNCT03166371
Glutathione (GSH) Supplementation After Hospitalization
A study testing Liposomal Glutathione (GSH) in people with Malnutrition, run by Emory University.
Trial summary
The purpose of this study is to see if oral liquid glutathione treatment, has any effect on improving health-related cellular protection, muscle size and strength, and fatigue, weakness, and quality of life in older adults with a history of malnutrition who have been hospitalized. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Liposomal Glutathione (GSH)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to Emory University Hospital (EUH) and residing at home (including assisted living settings) before and after hospitalization
- Subject has voluntarily signed and dated an informed consent
- Greater than or equal to 5 and no more than 15 consecutive overnight stays in an Emory University Hospital general ward and/or Surgical Intensive Care Unit (SICU) or Medical Intensive Care Unit (MICU) during the current hospital admission
- Currently admitted to a general medical or surgical hospital ward at EUH and able to tolerate oral solid diet
- Positive screening prior to entry for mild, moderate or severe malnutrition by standard Centers for Medicare/Medicaid Services (CMS) criteria after hospital admission
- Currently mobile on hospital ward and able to be transported (wheelchair) to Clinical Research Unit for baseline testing
Show all 10Show fewer
- Functionally ambulatory (self-reported ability to walk across a small room without assistance) during the 30 days prior to admission
- Ability to stand without assistance at the time of baseline testing
- Body mass index (BMI) >18.5, <40 mg/kg2
- Living within 40 miles of EUH
Who cannot join
- Subject not expected to be discharged to usual home or assisted living setting
- Requires tube feeding and/or parenteral nutrition in home/assisted living setting
- Planned or elective re-hospitalization within 90 days of discharge
- Inability to return to the EUH Clinical Research Unit for follow up study visits at 30, 60 and 90 days after entry into study
- History of acute or chronic gastrointestinal tract disorder that, in the opinion of the principal investigator would preclude ingestion or absorption of the study product (e.g., prior gastric bypass surgery, short bowel syndrome, inflammatory bowel disease, celiac disease, acute/chronic pancreatitis, or chronic upper gastrointestinal bleeding
- Current dementia, acute/chronic altered mental status, encephalopathy, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the principal investigator
Show all 12Show fewer
- History of stroke with motor disability or other significant movement disorders precluding protocol functional strength testing
- Acute hepatic failure during current hospitalization with total serum bilirubin > 3.5 mg/dL or transaminase values [alanine transaminase (ALT) and/or aspartate transaminase (AST) values > 3-fold the upper limit of normal range]
- Chronic or acute renal failure requiring chronic dialysis in home/assisted living setting after discharge
- Current active cancer or recently (within 6 months) treated cancer other than basal cell or squamous cell carcinoma of the skin or prostate cancer
- Participation in another research protocol within 30 days of entry into the current study or within 60 days after entry
- Any other condition or event considered exclusionary by the principal investigator
About this study
Official title: Bioavailable Glutathione Supplementation: During Hospitalization and Beyond
The purpose of this study is to see if oral liquid glutathione treatment, has any effect on improving health-related cellular protection, muscle size and strength, and fatigue, weakness, and quality of life in older adults with a history of malnutrition who have been hospitalized. Persons enrolled in this study will be those initially admitted to Emory University Hospital (EUH) in Atlanta, GA, but recovering and ready to be discharged home or to an assisted living facility to eat an oral diet. A combination of nutritional measures, blood markers and imaging tools will assess body composition. Study participants will complete questionnaires about quality of life and physical health, and do simple testing for physical strength and stamina. Information from this pilot study will increase understanding of a simple intervention which may prevent or reduce health risks related to hospital recovery in older adults.
Read the detailed description
This is a single-center randomized, double blind, placebo-controlled, intent-to-treat clinical trial to test the impact of oral administration of liposomal glutathione (GSH) in initially hospitalized, malnourished, older adults after discharge to the home setting. Study subjects will be clinically stable and able to complete serial study endpoint investigations. A total of 50 clinically stable subjects will be block-randomized to receive either oral liposomal GSH or identical placebo product for 90 days after discharge from Emory University Hospital (EUH). Plasma GSH redox status over time will be the primary study endpoint. Secondary study endpoints will include other thiol/disulfide indexes of oxidative stress, body composition, and measures of physical function, mobility, fatigue, frailty and quality of life. All endpoints will be determined at baseline (just prior to hospital discharge) and repeated at 30, 60 and 90 days after hospital discharge to the home or assisted living environment.
- Conditions
- Malnutrition
- Being tested
- Liposomal Glutathione (GSH), Placebo
- Keywords
- Endocrinology, Nutrition, Aging
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Glutathione (GSH)Dietary supplement
Also called ReadiSorb®
Two teaspoons (containing 840 mg GSH, 420 mg/tsp) liposomal GSH (ReadiSorb®) will be taken orally twice daily for a total daily dose of 1680 mg GSH/day. Liposomal GSH will be refrigerated until use and mixed in ≈ 250 mL water or juice for oral intake. The study product will be consumed daily for 90 consecutive days after hospital discharge.
PlaceboOther
Two teaspoons of placebo product will be taken orally twice daily. The placebo will be refrigerated until use and mixed in ≈ 250 mL water or juice for oral intake. The placebo will be consumed daily for 90 consecutive days after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Glutathione (GSH) | Experimental | Participants will be randomized to receive two teaspoons containing 840 mg GSH (420 mg/tsp) twice daily for 90 days after discharge from Emory University Hospital (EUH). Receives: Dietary Supplement: Liposomal Glutathione (GSH) |
| Placebo | Placebo comparator | Participants will be randomized to receive a placebo product identical to liposomal glutathione (GSH) twice daily for 90 days after discharge from Emory University Hospital (EUH). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Concentrations of GSH
Plasma concentrations of GSH will be collected via blood draw.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in GSH/glutathione Disulfide (GSSG) Concentration Ratio
GSH concentrations will be compared to glutathione disulfide. Concentrations will be collected and analyzed via blood draw.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in GSH/GSSH Pool Redox Potential (Eh)
GSH and GSSH will be collected via blood draw. Redox potential is a measure of the tendency of a chemical species to acquire electrons and thereby be reduced. The more positive the potential, the greater the affinity for electrons and tendency to be reduced
Measured: Baseline, Post Hospital Discharge (90 Days)
Secondary outcomes (19)
Body Composition assessed by Dual Energy X-ray Absorptiometry (DEXA) Scan
The DEXA scan will assess body composition by defining lean body mass, total fat mass, and visceral fat mass.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Waist Circumference
Waist circumference will be measured in centimeters. Change is defined as the difference in measurements from baseline to 90 days post discharge.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Hip Circumference
Hip circumference will be measured in centimeters. Change is defined as the difference in measurements from baseline to 90 days post discharge.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Body Mass Index (BMI)
Body mass index (BMI) is a measure of body fat based on height and weight. A BMI below 18.5 = Underweight; 18.5 - 24.9 = Normal; 25.0 - 29.9 = Overweight; 30.0 and Above = Obese.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Total Body Water (TBW) Volume
Body water is the water content that is contained in the tissues, the blood, the bones and elsewhere. The average TBW% ranges for a healthy adult are: Females - 45 to 60%, Males - 50 to 65%.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Intracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)
Intracellular water volume refers to water located within the cell. This will be measured by BIA, a method used for estimating body composition.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Extracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)
Extracellular water volume refers to water located outside of the cell. This will be measured by BIA, a method used for estimating body composition.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Phase Angle Measurements assessed by Bioelectrical Impedance Analysis (BIA)
Phase angle is an indicator of cellular health and integrity. A low phase angle is consistent with an inability of cells to store energy and an indication of breakdown in the selective permeability of cellular membranes. A high phase angle is consistent with large quantities of intact cell membranes and body cell mass.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Short Physical Performance Battery Score
The Short Physical Performance Battery (SPPB) is a tool to assess lower extremity physical performance status.The scores range from 0 (worst performance) to 12 (best performance).
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Timed Up and Go Test Score
The Timed Up and Go Test assesses mobility. Participants are asked to walk to a line 9.8 feet away, turn around at the line, and walk back at a normal pace. An older adult who takes ≥12 seconds to complete the TUG is at high risk for falling.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Grip Strength assessed by Hand-Grip Dynamometry
Handgrip Dynamometers are instruments for measuring the maximum isometric strength of the hand and forearm muscles, used for testing handgrip strength. Hand muscle measurements are as follows:
Grade 5: full active range of motion \& Normal muscle resistance Grade 4: full active range of motion \& Reduced muscle resistance Grade 3: full active range of motion \& No muscle resistance Grade 2: Reduced active range of motion \& No muscle resistance Grade 1: No active range of motion \& Palpable muscle contraction only Grade 0: No active range of motion \& No palpable muscle contraction
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Life Space Assessment Questionnaire Score
The Life Space Assessment Questionnaire assesses how much the person gets out and about and the spatial extent of the person's typical life space, i.e., what is the usual range of places in which the person engages in activities within the designated time frame.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Iowa Fatigue Scale Score
The Iowa Fatigue Scale assesses fatigue over the past month. General fatigue is a score between 30 and 39. Severe fatigue is a defined as a score between 40 - 55.
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Edmonton Frail Scale Score
The Edmonton Frail Scale assesses and stratifies frailty. Scores range from 0-5 "not frail", 6-7 "vulnerable", 8-9 "mild frailty", 10-11 "moderate frailty", and 12-17 "severe frailty".
Measured: Baseline, Post Hospital Discharge (90 Days)
Change in Fatigue Symptom Inventory (FSI) Score
The Fatigue Symptom Inventory (FSI), is a 14-item self-report measure designed to assess the severity, frequency, and daily pattern of fatigue as well as its perceived interference with quality of life.
Measured: Baseline, Post Hospital Discharge (90 Days)
Plasma Concentrations of Cysteine (Cys)
Plasma concentrations Cysteine (Cys) will be collected via blood draw.
Measured: Baseline, Post Hospital Discharge (90 Days)
Plasma Concentrations of Cistine (CySS)
Plasma concentrations CySS will be collected via blood draw.
Measured: Baseline, Post Hospital Discharge (90 Days)
Cys/CySS Ratio
Cys concentrations will be compared to CySS. Concentrations will be collected and analyzed via blood draw.
Measured: Baseline, Post Hospital Discharge (90 Days)
Cys/CySS Pool Redox Potential
Cys and CySS will be collected via blood draw. Redox potential is a measure of the tendency of a chemical species to acquire electrons and thereby be reduced. The more positive the potential, the greater the affinity for electrons and tendency to be reduced
Measured: Baseline, Post Hospital Discharge (90 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study startFeb 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Why it stopped: Study was withdrawn prior to enrolling participants after being suspended due to funding and staffing issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Your Energy Systems, LLC
- Responsible party
- Principal investigator, Thomas R. Ziegler, MD, Emory University
- Investigators
- Thomas R Ziegler, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166371
- Sponsor's protocol ID
- IRB00095819
- Status last verified
- Jan 2022
- First submitted
- 12 May 2017
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailable Glutathione Supplementation: During Hospitalization and Beyond
- ClinicalTrials.gov ID
- NCT03166371
- Acronym / sponsor ID
- IRB00095819
- Conditions
- Malnutrition
- Keywords
- Endocrinology, Nutrition, Aging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was withdrawn prior to enrolling participants after being suspended due to funding and staffing issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Your Energy Systems, LLC
- Study start
- Feb 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if oral liquid glutathione treatment, has any effect on improving health-related cellular protection, muscle size and strength, and fatigue, weakness, and quality of life in older adults with a history of malnutrition who have been hospitalized. Persons enrolled in this study will be those initially admitted to Emory University Hospital (EUH) in Atlanta, GA, but recovering and ready to be discharged home or to an assisted living facility to eat an oral diet. A combination of nutritional measures, blood markers and imaging tools will assess body composition. Study participants will complete questionnaires about quality of life and physical health, and do simple testing for physical strength and stamina. Information from this pilot study will increase understanding of a simple intervention which may prevent or reduce health risks related to hospital recovery in older adults.
Detailed description
This is a single-center randomized, double blind, placebo-controlled, intent-to-treat clinical trial to test the impact of oral administration of liposomal glutathione (GSH) in initially hospitalized, malnourished, older adults after discharge to the home setting. Study subjects will be clinically stable and able to complete serial study endpoint investigations. A total of 50 clinically stable subjects will be block-randomized to receive either oral liposomal GSH or identical placebo product for 90 days after discharge from Emory University Hospital (EUH). Plasma GSH redox status over time will be the primary study endpoint. Secondary study endpoints will include other thiol/disulfide indexes of oxidative stress, body composition, and measures of physical function, mobility, fatigue, frailty and quality of life. All endpoints will be determined at baseline (just prior to hospital discharge) and repeated at 30, 60 and 90 days after hospital discharge to the home or assisted living environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Glutathione (GSH) | Experimental | Dietary Supplement: Liposomal Glutathione (GSH)Participants will be randomized to receive two teaspoons containing 840 mg GSH (420 mg/tsp) twice daily for 90 days after discharge from Emory University Hospital (EUH). |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be randomized to receive a placebo product identical to liposomal glutathione (GSH) twice daily for 90 days after discharge from Emory University Hospital (EUH). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Admitted to Emory University Hospital (EUH) and residing at home (including assisted living settings) before and after hospitalization
- Subject has voluntarily signed and dated an informed consent
- Greater than or equal to 5 and no more than 15 consecutive overnight stays in an Emory University Hospital general ward and/or Surgical Intensive Care Unit (SICU) or Medical Intensive Care Unit (MICU) during the current hospital admission
- Currently admitted to a general medical or surgical hospital ward at EUH and able to tolerate oral solid diet
- Positive screening prior to entry for mild, moderate or severe malnutrition by standard Centers for Medicare/Medicaid Services (CMS) criteria after hospital admission
Key exclusion criteria (12 listed)
- Subject not expected to be discharged to usual home or assisted living setting
- Requires tube feeding and/or parenteral nutrition in home/assisted living setting
- Planned or elective re-hospitalization within 90 days of discharge
- Inability to return to the EUH Clinical Research Unit for follow up study visits at 30, 60 and 90 days after entry into study
- History of acute or chronic gastrointestinal tract disorder that, in the opinion of the principal investigator would preclude ingestion or absorption of the study product (e.g., prior gastric bypass surgery, short bowel syndrome, inflammatory bowel disease, celiac disease, acute/chronic pancreatitis, or chronic upper gastrointestinal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal Glutathione (GSH)Also: ReadiSorb®Two teaspoons (containing 840 mg GSH, 420 mg/tsp) liposomal GSH (ReadiSorb®) will be taken orally twice daily for a total daily dose of 1680 mg GSH/day. Liposomal GSH will be refrigerated until use and mixed in ≈ 250 mL water or juice for oral intake. The study product will be consumed daily for 90 consecutive days after hospital discharge. | Dietary supplement | Liposomal Glutathione (GSH) |
| PlaceboTwo teaspoons of placebo product will be taken orally twice daily. The placebo will be refrigerated until use and mixed in ≈ 250 mL water or juice for oral intake. The placebo will be consumed daily for 90 consecutive days after hospital discharge. | Other | Placebo |
Primary outcome
Change in Plasma Concentrations of GSH
Time frame: Baseline, Post Hospital Discharge (90 Days)
Plasma concentrations of GSH will be collected via blood draw.
Change in GSH/glutathione Disulfide (GSSG) Concentration Ratio
Time frame: Baseline, Post Hospital Discharge (90 Days)
GSH concentrations will be compared to glutathione disulfide. Concentrations will be collected and analyzed via blood draw.
Change in GSH/GSSH Pool Redox Potential (Eh)
Time frame: Baseline, Post Hospital Discharge (90 Days)
GSH and GSSH will be collected via blood draw. Redox potential is a measure of the tendency of a chemical species to acquire electrons and thereby be reduced. The more positive the potential, the greater the affinity for electrons and tendency to be reduced
19 secondary outcomes
Body Composition assessed by Dual Energy X-ray Absorptiometry (DEXA) Scan
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Waist Circumference
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Hip Circumference
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Body Mass Index (BMI)
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Total Body Water (TBW) Volume
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Intracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Extracellular Water Volume assessed by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Phase Angle Measurements assessed by Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Short Physical Performance Battery Score
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Timed Up and Go Test Score
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Grip Strength assessed by Hand-Grip Dynamometry
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Life Space Assessment Questionnaire Score
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Iowa Fatigue Scale Score
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Edmonton Frail Scale Score
Time frame: Baseline, Post Hospital Discharge (90 Days)
Change in Fatigue Symptom Inventory (FSI) Score
Time frame: Baseline, Post Hospital Discharge (90 Days)
Plasma Concentrations of Cysteine (Cys)
Time frame: Baseline, Post Hospital Discharge (90 Days)
Plasma Concentrations of Cistine (CySS)
Time frame: Baseline, Post Hospital Discharge (90 Days)
Cys/CySS Ratio
Time frame: Baseline, Post Hospital Discharge (90 Days)
Cys/CySS Pool Redox Potential
Time frame: Baseline, Post Hospital Discharge (90 Days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
Related trials for Malnutrition
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Not yet recruiting
Tolerance and Acceptability of an Oral Nutrition Supplement
Disease Related Malnutrition
RecruitingObservational study
Clinical and Laboratory Study of Methylmalonic Acidemia
Organic Acidemia, Methylmalonic Acidemia
RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
Recruiting
Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis
Hepatic Cytolysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R Ziegler, MD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal Glutathione (GSH) in people with Malnutrition, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plasma Concentrations of GSH (time frame: Baseline, Post Hospital Discharge (90 Days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.