Vaccine Adverse ReactionPhase 2ViTAL-SCAN19NCT06967428
Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort
A Phase 2 study testing Combined metabolic modulator and Rice Protein Powder with Vitamin C in people with Vaccine Adverse Reaction and Post Acute Covid-19 Vaccination Syndrome, run by Independent Medical Alliance at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Vaccine Adverse Reaction, Post Acute Covid-19 Vaccination Syndrome
- What is being tested?
- Combined metabolic modulator and Rice Protein Powder with Vitamin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to Jan 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persistent fatigue lasting more than 6 months
- Received at least one dose of a Covid-19 vaccine, after which they experienced fatigue symptoms (symptom onset within two weeks of vaccination)
- Laboratory result showing persistent spike protein in blood OR presence of spike protein antibodies with SARS-CoV-2 nucleocapsid antibodies negative.
Who cannot join
- Pregnant
- History of Schizophrenia
- Currently using antidepressant medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dorrington Medical Associates
Houston, Texas, 77030
Joseph Varon, MD, +17136691670, jvaron@imahealth.org
About this study
Official title: Effectiveness of Metabolic Modulation in Treating Post-vaccination Syndrome: A Prospective Study
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:
Read more
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.
- Being tested
- Combined metabolic modulator, Rice Protein Powder with Vitamin C
- Keywords
- Post Acute Covid-19 Vaccination Syndrome, Metabolic Modulation, Amino Acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined metabolic modulatorCombination 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.
Rice Protein Powder with Vitamin CDietary supplement
Rice Protein Powder (39g) with Vitamin C (1g) daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Combined metabolic modulator |
| Rice Protein Powder and Vitamin C | Active comparator | A mass-matched supplement of rice protein powder with vitamin C. Receives: Dietary Supplement: Rice Protein Powder with Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAC-19QoL Questionnaire
Combined score of an established survey instrument for Quality of Life in the context of Post-Acute Covid-19 Syndrome (PACS).
Measured: 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.
Measured: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Secondary outcomes (14)
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.
Measured: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Total Cholesterol
Measured: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
HDL-Cholesterol
Measured: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
LDL-Cholesterol
Measured: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Triglycerides
Measured: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Adverse ReactionStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Independent Medical Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Open Source Medicine Foundation OU
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967428
- Sponsor's protocol ID
- ViTAL-SCAN for PACVS
- Acronym
- ViTAL-SCAN19
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Demographic data (Age, sex and US census category for ethnicity), Baseline, Interim and final measurements of outcome measures.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Metabolic Modulation in Treating Post-vaccination Syndrome: A Prospective Study
- ClinicalTrials.gov ID
- NCT06967428
- Acronym / sponsor ID
- ViTAL-SCAN19 / ViTAL-SCAN for PACVS
- Keywords
- Post Acute Covid-19 Vaccination Syndrome, Metabolic Modulation, Amino Acids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Independent Medical AllianceUniversity, hospital or other
- Collaborators
- Open Source Medicine Foundation OU
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 13 May 2025 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ViTAL SCAN | Experimental | Combination Product: Combined metabolic modulatorThis 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. |
| Rice Protein Powder and Vitamin C | Active comparator | Dietary Supplement: Rice Protein Powder with Vitamin CA mass-matched supplement of rice protein powder with vitamin C. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Persistent fatigue lasting more than 6 months
- Received at least one dose of a Covid-19 vaccine, after which they experienced fatigue symptoms (symptom onset within two weeks of vaccination)
- Laboratory result showing persistent spike protein in blood OR presence of spike protein antibodies with SARS-CoV-2 nucleocapsid antibodies negative.
Key exclusion criteria (3 listed)
- Pregnant
- History of Schizophrenia
- Currently using antidepressant medication
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 |
|---|---|---|
| Combined metabolic modulatorThis 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. | Combination product | ViTAL SCAN |
| Rice Protein Powder with Vitamin CRice Protein Powder (39g) with Vitamin C (1g) daily | Dietary supplement | Rice Protein Powder and Vitamin C |
Primary outcome
PAC-19QoL Questionnaire
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Combined score of an established survey instrument for Quality of Life in the context of Post-Acute Covid-19 Syndrome (PACS).
Six-minute walk test
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
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.
14 secondary outcomes
Hemoglobin A1c
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Sedentary blood lactate
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Post-exertion blood lactate
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
C-Reactive Protein
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Spike protein levels
Time frame: From an initial test at enrollment to another at the end of treatment at 3 months"
Resting Heart Rate Variability
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Heart rate variability during 6MWT
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Resting Heart Rate
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Heart Rate during 6MWT
Time frame: 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
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Total Cholesterol
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
HDL-Cholesterol
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
LDL-Cholesterol
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Triglycerides
Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized Demographic data (Age, sex and US census category for ethnicity), Baseline, Interim and final measurements of outcome measures.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combined metabolic modulator and Rice Protein Powder with Vitamin C in people with Vaccine Adverse Reaction and Post Acute Covid-19 Vaccination Syndrome, run by Independent Medical Alliance 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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 13 May 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Halma (+504 8948 1885, mhalma@imahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAC-19QoL Questionnaire (time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"). The study lists 2 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 13 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.