Post-polio SyndromeNCT01402570
Glutathione and Health With Post-Polio Syndrome
A study testing Glutathione in people with Post-polio Syndrome and Physical Activity, run by University of Michigan at 1 site in United States.
Trial summary
In this study, people who have symptoms of post polio will take oral glutathione supplements for three months. Their levels of fatigue, physical activity and sleep efficiency will be assessed. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Post-polio Syndrome, Physical Activity, Depression
- What is being tested?
- Glutathione
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to walk 100 feet with usual assistive devices (ex. cane or walker)
- Having a function score of 18-32 when tested with the IPPS (Index of Post- Polio Sequelae). This will include people with post-polio symptoms in a very specific range of severity.
Who cannot join
- Having another serious medical condition (cancer, multiple sclerosis, etc.)or inflammatory disease (ie., lupus)
- Currently taking glutathione or other antioxidants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Glutathione and Health Outcomes Among Persons With Post-Polio Syndrome
In this study, people who have symptoms of post polio will take oral glutathione supplements for three months. Their levels of fatigue, physical activity and sleep efficiency will be assessed.
Read the detailed description
Subjects will take a glutathione supplement by mouth for three months after an initial medical visit, blood draw and physical exam. There are four timepoints during the three months when subjects will fill out surveys and record food intake and sleep times in diaries for seven days. They will also wear a small device for seven days, a Sensewear monitor that records physical activity, body temperature and other measures.
After the fourth timepoint they will return to the medical center for another physical exam and blood draw. Physicians trained in physical medicine and rehabilitation will be monitoring the study.
- Conditions
- Post-polio Syndrome, Physical Activity, Depression, Pain, Sleep Disorders
- Being tested
- Glutathione
- Keywords
- disability, polio, rehabilitation, wellness
- Medical subject headings
- Postpoliomyelitis Syndrome, Motor Activity, Depression, Pain, Sleep Wake Disorders, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutathioneDietary supplement
Also called 500 Ultrathoine, GSH and l-glutathione.
glutathione is a dietary supplement and an antioxidant. Subjects will take 1000 mg per day for three month. Each capsule contains 500 mg glutathione.
| Study group | Role | What they receive |
|---|---|---|
| Glutathione supplement | Experimental | All subjects will be taking a glutathione supplement.Glutathione is a naturally occuring antioxidant and a nonessential amino acid. Receives: Dietary Supplement: Glutathione |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning
Ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function.
Measured: Baseline, 1 month, 2 months and 3 months
Sleep Efficiency
The ratio of time asleep over time in bed gathered from sleep diaries completed at bedtime and at awakening. Scores range from 0 to 100%, higher values indicate better sleep efficiency or more time sleeping in bed.
Measured: Baseline, 1 month, 2 months and 3 months
Steps Per Day
Count of steps per day using activity monitor worn on upper arm.
Measured: Baseline, 1 month, 2 months and 3 months
PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue
Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one's ability to carry out daily activities, including the ability to work effectively and to function at one's usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities. Scores are on a T-metric with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.
Measured: Baseline, 1 month, 2 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-polio SyndromeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Principal investigator, Claire Z. Kalpakjian, University of Michigan
- Investigators
- Claire Kalpakjian, PhD, MS, Principal investigator, University of MichiganMark Ziadeh, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402570
- Sponsor's protocol ID
- PPH-1051
- Status last verified
- Dec 2016
- First submitted
- 25 Jul 2011
- Last updated
- 17 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Glutathione and Health Outcomes Among Persons With Post-Polio Syndrome
- ClinicalTrials.gov ID
- NCT01402570
- Acronym / sponsor ID
- PPH-1051
- Conditions
- Post-polio Syndrome, Physical Activity, Depression, Pain, Sleep Disorders
- Keywords
- disability, polio, rehabilitation, wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- Aug 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Posted 17 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, people who have symptoms of post polio will take oral glutathione supplements for three months. Their levels of fatigue, physical activity and sleep efficiency will be assessed.
Detailed description
Subjects will take a glutathione supplement by mouth for three months after an initial medical visit, blood draw and physical exam. There are four timepoints during the three months when subjects will fill out surveys and record food intake and sleep times in diaries for seven days. They will also wear a small device for seven days, a Sensewear monitor that records physical activity, body temperature and other measures.
After the fourth timepoint they will return to the medical center for another physical exam and blood draw. Physicians trained in physical medicine and rehabilitation will be monitoring the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glutathione supplement | Experimental | Dietary Supplement: GlutathioneAll subjects will be taking a glutathione supplement.Glutathione is a naturally occuring antioxidant and a nonessential amino acid. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to walk 100 feet with usual assistive devices (ex. cane or walker)
- Having a function score of 18-32 when tested with the IPPS (Index of Post- Polio Sequelae). This will include people with post-polio symptoms in a very specific range of severity.
Key exclusion criteria (2 listed)
- Having another serious medical condition (cancer, multiple sclerosis, etc.)or inflammatory disease (ie., lupus)
- Currently taking glutathione or other antioxidants
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 |
|---|---|---|
| GlutathioneAlso: 500 Ultrathoine, GSH and l-glutathione.glutathione is a dietary supplement and an antioxidant. Subjects will take 1000 mg per day for three month. Each capsule contains 500 mg glutathione. | Dietary supplement | Glutathione supplement |
Primary outcome
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning
Time frame: Baseline, 1 month, 2 months and 3 months
Ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function.
Sleep Efficiency
Time frame: Baseline, 1 month, 2 months and 3 months
The ratio of time asleep over time in bed gathered from sleep diaries completed at bedtime and at awakening. Scores range from 0 to 100%, higher values indicate better sleep efficiency or more time sleeping in bed.
Steps Per Day
Time frame: Baseline, 1 month, 2 months and 3 months
Count of steps per day using activity monitor worn on upper arm.
PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue
Time frame: Baseline, 1 month, 2 months and 3 months
Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one's ability to carry out daily activities, including the ability to work effectively and to function at one's usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities. Scores are on a T-metric with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Claire Kalpakjian, PhD, MS principal investigator
University of Michigan
Mark Ziadeh, MD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutathione in people with Post-polio Syndrome and Physical Activity, run by University of Michigan at 1 site in United States.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning (time frame: Baseline, 1 month, 2 months and 3 months). The study lists 4 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 17 Feb 2017.