The goal of this clinical trial is to evaluate whether metabolic modulation with acombined nutraceutical product can improve symptoms and metabolic health in adultsdiagnosed with post-acute Covid-19 vaccination syndrome (PACVS), a conditioncharacterized by persistent fatigue and exercise intolerance attributed to Covid-19vaccination and confirmed by laboratory testing.The main questions it aims to answer are:Does the combined nutraceutical intervention improve quality of life (measured by thePAC-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 walkdistance)?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 theintervention 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-minutewalk test), and heart rate monitoringComplete quality of life and health behavior questionnairesUndergo measurements of metabolic and inflammatory markers (HbA1c, lactate, CRP, spikeprotein)Record supplement intakeThis study is currently pending IRB approval and aims to enroll 100 adults with PACVS fora randomized, placebo-controlled trial.
Not Provided
Combination Product: Combined metabolic modulator
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.
Dietary Supplement: Rice Protein Powder with Vitamin C
Rice Protein Powder (39g) with Vitamin C (1g) daily
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnant
- History of Schizophrenia
- Currently using antidepressant medication
Dorrington Medical Associates
Houston, Texas, United States
Investigator: Joseph Varon, MD
Contact: +17136691670
jvaron@imahealth.org
Matthew Halma
+504 8948 1885
mhalma@imahealth.org
Not Provided