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

NCT06967428 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: ViTAL-SCAN for PACVS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccine Adverse Reaction; Post Acute Covid-19 Vaccination Syndrome

Keywords

Post Acute Covid-19 Vaccination Syndrome; Metabolic Modulation; Amino Acids

Outcome Measures

Primary Outcomes (2)

• PAC-19QoL Questionnaire

  Combined score of an established survey instrument for Quality of Life in the context of Post-Acute Covid-19 Syndrome (PACS).

  From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

• Six-minute walk test

  A treadmill-administered version of the six minute walk test (6MWT) where patients walk for as long a distance as they can, without jogging or running, in 6 minutes.

  From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

Secondary Outcomes (14)

• Hemoglobin A1c

  From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

• Sedentary blood lactate

  From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

• Post-exertion blood lactate

  From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

• C-Reactive Protein

  From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"

• Spike protein levels

  From an initial test at enrollment to another at the end of treatment at 3 months"

Study Arms (2)

ViTAL SCAN

EXPERIMENTAL

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 modulate energy metabolism.

Combination Product: Combined metabolic modulator

Rice Protein Powder and Vitamin C

ACTIVE COMPARATOR

A mass-matched supplement of rice protein powder with vitamin C.

Dietary Supplement: Rice Protein Powder with Vitamin C

Interventions

Combined metabolic modulator COMBINATION_PRODUCT

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.

ViTAL SCAN

Rice Protein Powder with Vitamin C DIETARY_SUPPLEMENT

Rice Protein Powder (39g) with Vitamin C (1g) daily

Rice Protein Powder and Vitamin C

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant
• History of Schizophrenia
• Currently using antidepressant medication

Sponsors & Collaborators

• Independent Medical Alliance: lead
• Open Source Medicine Foundation OU: collaborator

Study Sites (1)

Dorrington Medical Associates

Houston, Texas, 77030, United States

Location

Related Links

• Study protocol

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Central Study Contacts

Matthew Halma

CONTACT

+504 8948 1885; mhalma@imahealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: September 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)