Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combined metabolic modulator, Rice Protein Powder with Vitamin C.
- Who it may be relevant to
- Registry conditions: Vaccine Adverse Reaction, Post Acute Covid-19 Vaccination Syndrome. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Metabolic Modulation in Treating Post-vaccination Syndrome: A Prospective Study
Overview
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.
Interventions
- 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
Primary outcome measures
- PAC-19QoL Questionnaire [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
- Six-minute walk test [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
Secondary outcome measures (12)
- Hemoglobin A1c [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
- Sedentary blood lactate [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
- Post-exertion blood lactate [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
- C-Reactive Protein [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
- Spike protein levels [Time frame: From an initial test at enrollment to another at the end of treatment at 3 months"]
- Resting Heart Rate Variability [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
- Heart rate variability during 6MWT [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
- Resting Heart Rate [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
- Heart Rate during 6MWT [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
- Post-exercise Borg category-ratio 10 scale [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
- Total Cholesterol [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
- HDL-Cholesterol [Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Dorrington Medical Associates — Houston
Identifiers
NCT: NCT06967428 · ViTAL-SCAN for PACVS