NCT06967428

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

Effectiveness of Metabolic Modulation in Treating Post-vaccination Syndrome: A Prospective Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Independent Medical Alliance · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study