Clinical trial NCT06967428: Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort
Official title: Effectiveness of Metabolic Modulation in Treating Post-vaccination Syndrome: A Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Vaccine Adverse Reaction
Post Acute Covid-19 Vaccination Syndrome
Keywords: Post Acute Covid-19 Vaccination Syndrome
Metabolic Modulation
Amino Acids
Lead sponsor: Independent Medical Alliance
Sponsor class: OTHER
Collaborators: name: Open Source Medicine Foundation OU
First posted: 2025-05-13
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: PAC-19QoL Questionnaire
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: Six-minute walk test
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: Sedentary blood lactate
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: Post-exertion blood lactate
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: C-Reactive Protein
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: Spike protein levels
timeFrame: From an initial test at enrollment to another at the end of treatment at 3 months"
measure: Resting Heart Rate Variability
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: Heart rate variability during 6MWT
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: Resting Heart Rate
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: Heart Rate during 6MWT
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: Post-exercise Borg category-ratio 10 scale
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: Total Cholesterol
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: HDL-Cholesterol
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: LDL-Cholesterol
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
measure: Triglycerides
timeFrame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
Other outcomes:
Locations:
city: Houston
country: United States
facility: Dorrington Medical Associates
state: Texas
Study officials:
References: