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| Name | Class |
|---|---|
| Penn State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glutathione supplement | Experimental | All subjects will be taking a glutathione supplement.Glutathione is a naturally occuring antioxidant and a nonessential amino acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutathione | Dietary Supplement | glutathione is a dietary supplement and an antioxidant. Subjects will take 1000 mg per day for three month. Each capsule contains 500 mg glutathione. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline, 1 month, 2 months and 3 months |
| Steps Per Day | Count of steps per day using activity monitor worn on upper arm. | 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. | Baseline, 1 month, 2 months and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire Kalpakjian, PhD, MS | University of Michigan | Principal Investigator |
| Mark Ziadeh, MD | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | All subjects took a three month trials of 1,000 mg of glutathione supplement |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The target population for this study was individuals between the ages of 50 and 65 who self-reported symptoms consistent with post-polio syndrome and able to ambulate 100 feet without assistive devices.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month, 2 months and 3 months |
|
Entire study period of three months - baseline to the end of the trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| allergic reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Sample size of 20 was quite small to make generalizations to the larger population. Dosing and duration of the intervention may not have been sufficient to effect change.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claire Z. Kalpakjian | University of Michigan | 734-763-0153 | clairez@umich.edu |
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| ID | Term |
|---|---|
| D016262 | Postpoliomyelitis Syndrome |
| D009043 | Motor Activity |
| D003863 | Depression |
| D010146 | Pain |
| D012893 | Sleep Wake Disorders |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| ID | Term |
|---|---|
| D005978 | Glutathione |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| years |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PROMIS Physical Functioning | Assesses the 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. | Mean | Standard Deviation | units on a scale |
|
| Subjective sleep efficiency | Sleep efficiency is defined as the ratio of time sleeping and time in bed. Using a sleep diary, participants recorded bedtime the night before, amount of time it took to fall asleep, number and total duration of awakenings, time of final awakening, and time of rising. Efficiency ranges from 0 to 100; higher values indicate higher sleep efficiency or more time sleeping when in bed. | Mean | Standard Deviation | percentage |
|
| PROMIS 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 standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue. | Mean | Standard Deviation | units on a scale |
|
| Physical activity, number of steps daily | Refers to cumulative steps per day (24 hours period). 10,000 or more steps per day is considered optimal. | Mean | Standard Deviation | steps/day |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month, 2 months and 3 months |
|
|
|
|
| Primary | Steps Per Day | Count of steps per day using activity monitor worn on upper arm. | Posted | Mean | Standard Deviation | steps per day | Baseline, 1 month, 2 months and 3 months |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month, 2 months and 3 months |
|
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
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| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D019636 | Neurodegenerative Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
|
| 3 months |
|
| Title |
|---|
| Measurements |
|---|
|
| 3 months |
|
| Title | Measurements |
|---|---|
|
| 3 months |
|