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| Name | Class |
|---|---|
| Open Source Medicine Foundation OU | UNKNOWN |
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The goal of this clinical trial is to evaluate whether metabolic modulation with a combined nutraceutical product can improve symptoms and metabolic health in adults diagnosed with post-acute Covid-19 vaccination syndrome (PACVS), a condition characterized by persistent fatigue and exercise intolerance attributed to Covid-19 vaccination and confirmed by laboratory testing.
The main questions it aims to answer are:
Does the combined nutraceutical intervention improve quality of life (measured by the PAC-19QoL questionnaire) in PACVS patients?
Does the intervention improve metabolic, inflammatory, and functional biomarkers (e.g., HbA1c, blood lactate, CRP, spike protein levels, heart rate variability, 6-minute walk distance)?
Researchers will compare the intervention group (receiving the ViTAL SCAN nutraceutical) to a placebo group (receiving rice protein powder with vitamin C) to determine if the intervention leads to greater improvements in symptoms and biomarker profiles.
Participants will:
Take the assigned supplement daily for 3 months (ViTAL SCAN or placebo)
Attend clinic visits for blood and urine sampling, physical performance tests (6-minute walk test), and heart rate monitoring
Complete quality of life and health behavior questionnaires
Undergo measurements of metabolic and inflammatory markers (HbA1c, lactate, CRP, spike protein)
Record supplement intake
This study is currently pending IRB approval and aims to enroll 100 adults with PACVS for a randomized, placebo-controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ViTAL SCAN | Experimental | This daily intervention over 3 months combines 4 g L-serine, 14 g L-glutamine, 3 g L-arginine, 2.5 g N-acetylcysteine, 5.75 g L-citrulline, 1 g vitamin C, and 5 g creatine to modulate energy metabolism. |
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| Rice Protein Powder and Vitamin C | Active Comparator | A mass-matched supplement of rice protein powder with vitamin C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined metabolic modulator | Combination Product | This daily intervention over 3 months combines 4 g L-serine, 14 g L-glutamine, 3 g L-arginine, 2.5 g N-acetylcysteine, 5.75 g L-citrulline, 1 g vitamin C, and 5 g creatine to support energy metabolism. |
| Measure | Description | Time Frame |
|---|---|---|
| PAC-19QoL Questionnaire | Combined score of an established survey instrument for Quality of Life in the context of Post-Acute Covid-19 Syndrome (PACS). | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| Six-minute walk test | A treadmill-administered version of the six minute walk test (6MWT) where patients walk for as long a distance as they can, without jogging or running, in 6 minutes. | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | Hemoglobin A1c (HbA1c) reflects longer term blood sugar levels. Given that metabolism is altered in PACS patients, it may be valuable to assess their metabolic health. Elevated HbA1c was associated with an increased mortality during the acute phase of the Covid-19. | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Halma | Contact | +504 8948 1885 | mhalma@imahealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dorrington Medical Associates | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| Study protocol | View source |
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Anonymized Demographic data (Age, sex and US census category for ethnicity), Baseline, Interim and final measurements of outcome measures.
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| Rice Protein Powder with Vitamin C | Dietary Supplement | Rice Protein Powder (39g) with Vitamin C (1g) daily |
|
| Sedentary blood lactate | Blood lactate when the patient is at rest is taken using the Arkray Lactate Pro 2 Sports Blood Lactate Meter, which uses disposable test strips. | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| Post-exertion blood lactate | Blood lactate taken after the six-minute walk test. | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| C-Reactive Protein | C-reactive protein (CRP) , a marker of inflammation, has been found to be significantly different between long covid groups vs healthy individuals, as well as between long covid and recovered individuals. CRP is quantitatively measured at a laboratory attached to the study clinic using the Roche Cobas b 101 Blood Analyser using Roche cobas b 101 CRP Test Discs, supplied in packs of 10. Each test required a 12 μL sample of capillary whole blood, obtained via finger prick. Upon completion of the assay, CRP concentrations are recorded in mg/L with that patient's identification number. The analytical range is 3.0-400 mg/L; if a test returns an error, the value will be reported as missing. | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| Spike protein levels | Spike protein tests will be performed using the MSD S-PLEX SARS-CoV-2 Spike Kit using a SECTOR Imager 2400 plate reader. | From an initial test at enrollment to another at the end of treatment at 3 months" |
| Resting Heart Rate Variability | Heart Rate Variability is taken at rest using a Garmin vívosmart® 5. | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| Heart rate variability during 6MWT | HRV is taken using a Garmin vívosmart® 5 at the halfway point of the 6 minute walk test. | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| Resting Heart Rate | Resting Heart Rate is taken using a Garmin vívosmart® 5. | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| Heart Rate during 6MWT | Average heart rate is taken during the last three minutes of the 6MWT | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| Post-exercise Borg category-ratio 10 scale | This test is used to assess the level of perceived exertion after the 6MWT by asking participants to rate their exertion on a scale of 1 to 10. This is useful as a measure of exercise intolerance. | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| Total Cholesterol | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| HDL-Cholesterol | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| LDL-Cholesterol | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| Triglycerides | From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months" |
| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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