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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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