Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort
Starting soon · Phase 2
Conditions studied: Vaccine Adverse Reaction, Post Acute Covid-19 Vaccination Syndrome
In brief
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.
Key facts
- Study ID
- NCT06967428
- Run by
- Independent Medical Alliance
- People needed
- 100
- Starts
- 2025-09-01
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2025-05-13
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Pregnant
- History of Schizophrenia
- Currently using antidepressant medication
Where it is running
- Dorrington Medical Associates — Houston, Texas, United States
Full record on ClinicalTrials.gov
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