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Набор скоро начнётся NCT06967428

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

Фаза II С лечением Vaccine Adverse Reaction Post Acute Covid-19 Vaccination Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Combined metabolic modulator, Rice Protein Powder with Vitamin C.
Кому может быть актуально
Состояния в реестре: Vaccine Adverse Reaction, Post Acute Covid-19 Vaccination Syndrome. Базовые параметры: от 16 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Комбинированный продукт 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.
  • Пищевая добавка Rice Protein Powder with Vitamin C
    Rice Protein Powder (39g) with Vitamin C (1g) daily

Первичные конечные точки

  • PAC-19QoL Questionnaire [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
  • Six-minute walk test [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
Вторичные конечные точки (12)
  • Hemoglobin A1c [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
  • Sedentary blood lactate [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
  • Post-exertion blood lactate [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
  • C-Reactive Protein [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
  • Spike protein levels [Срок оценки: From an initial test at enrollment to another at the end of treatment at 3 months"]
  • Resting Heart Rate Variability [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
  • Heart rate variability during 6MWT [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
  • Resting Heart Rate [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
  • Heart Rate during 6MWT [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
  • Post-exercise Borg category-ratio 10 scale [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
  • Total Cholesterol [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]
  • HDL-Cholesterol [Срок оценки: From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months"]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • Pregnant
  • History of Schizophrenia
  • Currently using antidepressant medication

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Dorrington Medical Associates — Houston

Идентификаторы

NCT: NCT06967428 · ViTAL-SCAN for PACVS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗