NCT06967428: ViTAL-SCAN19

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

Not yet recruiting Phase 2 Last updated 5 May 2025

What this trial tests

Phase 2 trial testing Combined metabolic modulator in Vaccine Adverse Reaction in 100 participants. Not yet recruiting.

Timeline

1 September 2025

Primary endpoint
1 January 2026

1 January 2026

Quick facts

Lead sponsor	Independent Medical Alliance
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	100
Start date	1 September 2025
Primary completion	1 January 2026
Estimated completion	1 January 2026
Sites	1 location across United States

Drugs / interventions tested

• Combined metabolic modulator
• Rice Protein Powder with Vitamin C

Conditions studied

• Vaccine Adverse Reaction — all drugs for Vaccine Adverse Reaction →
• Post Acute Covid-19 Vaccination Syndrome — all drugs for Post Acute Covid-19 Vaccination Syndrome →

Sponsor

Independent Medical Alliance

Who can join

16 and older, any sex, with Vaccine Adverse Reaction or Post Acute Covid-19 Vaccination Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• PAC-19QoL Questionnaire
  Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
  Combined score of an established survey instrument for Quality of Life in the context of Post-Acute Covid-19 Syndrome (PACS).
• Six-minute walk test
  Time frame: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"
  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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.