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Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort

NCT06967428 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-13

No results posted yet for this study

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.

Conditions

  • Vaccine Adverse Reaction
  • Post Acute Covid-19 Vaccination Syndrome

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

Sponsors & Collaborators

  • Open Source Medicine Foundation OU

    collaborator UNKNOWN

  • Independent Medical Alliance

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06967428 on ClinicalTrials.gov