Official Title
Effectiveness of Metabolic Modulation in Treating Post-vaccination Syndrome: A Prospective Study
Brief Summary

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.

Detailed Description

Not Provided

Not yet recruiting
Vaccine Adverse Reaction
Post Acute Covid-19 Vaccination Syndrome

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 16 Years ~ Maximum: N/A
Countries
United States
Locations

Dorrington Medical Associates
Houston, Texas, United States

Investigator: Joseph Varon, MD
Contact: +17136691670
jvaron@imahealth.org

Contacts

Matthew Halma
+504 8948 1885
mhalma@imahealth.org

Not Provided

Open Source Medicine Foundation OU
NCT Number
Keywords
Post Acute Covid-19 Vaccination Syndrome
Metabolic Modulation
Amino Acids
MeSH Terms
COVID-19
Syndrome