Nutritional Supplement for COVID-19 Vaccine Side Effects

(ViTAL-SCAN19 Trial)

Overseen By Matthew Halma

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Independent Medical Alliance

Must not be taking: Antidepressants

Disqualifiers: Pregnant, Schizophrenia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a nutritional supplement can reduce symptoms like fatigue in individuals with ongoing issues after receiving a COVID-19 vaccine. It compares the effects of a nutraceutical called ViTAL SCAN with a placebo to determine if it improves quality of life and certain health markers. Eligible participants should have experienced persistent fatigue for over six months after vaccination, with specific lab results showing spike protein in the blood. Participants will take their assigned supplement daily for three months and attend clinic visits for various health checks. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that participants not be using antidepressant medication. If you are on antidepressants, you would need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that the ingredients in ViTAL SCAN, such as L-serine and L-glutamine, were generally well-tolerated. These amino acids help the body make proteins. Research has shown that these ingredients have been safely used in various dietary supplements and nutritional therapies. However, specific information on the safety of the exact combination in ViTAL SCAN is not available.

Since this trial is in an early stage, the safety of ViTAL SCAN is still under investigation, and further research is needed to confirm its safety. This trial will compare ViTAL SCAN with a placebo to better understand any possible side effects. Participants will be closely monitored for any negative effects during the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ViTAL SCAN because it offers a unique approach to managing COVID-19 vaccine side effects by targeting energy metabolism. Unlike typical treatments that address symptoms with medications like pain relievers or antihistamines, ViTAL SCAN combines amino acids such as L-serine, L-glutamine, and L-arginine with antioxidants like vitamin C and N-acetylcysteine to support cellular energy and immune function. This nutritional intervention could potentially modulate the body's response to the vaccine, enhancing overall well-being without relying on traditional pharmaceuticals.

What evidence suggests that this nutraceutical is effective for post-acute Covid-19 vaccination syndrome?

Research suggests that the ViTAL SCAN supplement, which participants in this trial may receive, might help alleviate symptoms in individuals experiencing post-acute COVID-19 vaccination syndrome (PACVS). This condition often involves ongoing tiredness and difficulty with exercise after receiving a COVID-19 vaccine. ViTAL SCAN contains ingredients such as L-serine, L-glutamine, L-arginine, N-acetylcysteine, L-citrulline, vitamin C, and creatine, which are believed to enhance the body's energy utilization. This could potentially reduce tiredness and improve exercise capacity. Although direct evidence on ViTAL SCAN's effectiveness for PACVS is not yet available, studies have examined how its individual ingredients support energy use in the body. Another group in this trial will receive a mass-matched supplement of rice protein powder with vitamin C as an active comparator. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults with post-acute Covid-19 vaccination syndrome (PACVS), experiencing persistent fatigue and exercise intolerance after a Covid vaccine. Participants must be diagnosed through lab tests and willing to take supplements, attend clinic visits, undergo testing, and complete questionnaires for 3 months.

Inclusion Criteria

Laboratory result showing persistent spike protein in blood OR presence of spike protein antibodies with SARS-CoV-2 nucleocapsid antibodies negative.

I have been feeling very tired for over 6 months.

I felt tired after getting a dose of the Covid-19 vaccine.

Exclusion Criteria

History of Schizophrenia

I am currently taking medication for depression.

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take the assigned supplement daily for 3 months and attend clinic visits for blood and urine sampling, physical performance tests, and heart rate monitoring

12 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ViTAL SCAN

Trial Overview The trial is testing if a nutraceutical called ViTAL SCAN can improve quality of life and metabolic health in PACVS patients compared to a placebo (rice protein powder with vitamin C). It measures the effects on quality of life, metabolic markers like HbA1c, inflammation levels, heart rate variability, and physical performance.

How Is the Trial Designed?

Group I: ViTAL SCAN Experimental Treatment 1 Intervention

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.

Group II: Rice Protein Powder and Vitamin C Active Control 1 Intervention

A mass-matched supplement of rice protein powder with vitamin C.

Who Is Running the Clinical Trial?

Independent Medical Alliance

Lead Sponsor

Open Source Medicine Foundation OU

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10507236/

Review of adverse events associated with COVID-19 vaccines ... Rare adverse effects of COVID-19 vaccines include anaphylaxis, blood clots, myocarditis, pericarditis, hearing changes, and tinnitus.

2. cdc.gov cdc.gov/acip/downloads/slides-2025-06-25-26/04-Meyer-COVID-508.pdf

Update on CDC's COVID-19 Vaccine Safety Monitoring Co-managed by CDC and FDA. • Nationwide spontaneous reporting system that can rapidly detect safety signals, including rare events.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25011399

Differentiating COVID-19 vaccine-related adverse events ... The global deployment of COVID-19 vaccines has introduced diagnostic challenges due to overlapping symptoms with long COVID, or post-acute sequelae of ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/eci.14296

COVID‐19 vaccine adverse events: Evaluating the ... In this narrative review, we assess the pathophysiology of severe adverse events that presented after vaccination with DNA and mRNA vaccines against COVID-19.

5. pfizer.com pfizer.com/news/announcements/pfizer-shares-available-analyses-myocarditis-and-covid-19-vaccines

Pfizer Shares Available Analyses of Myocarditis and ... A systematic review and meta-analysis found that the risk of myocarditis after COVID-19 infection is approximately 42 times higher than the risk ...

6. vaers.hhs.gov vaers.hhs.gov/

Vaccine Adverse Event Reporting System (VAERS) Have you had a reaction following a vaccination? · Report an Adverse Event · Search VAERS Data · Review Resources · Submit Follow-up Information · Helpful Links.

7. mdpi.com mdpi.com/2673-8112/5/2/16

A Bibliometric Review of COVID-19 Vaccines and Their ... While many studies focused on common side effects, such as headache, fatigue, and injection-site pain, rare but serious adverse events, such as myocarditis, ...