Effectiveness of Metabolic Modulation in Treating Post-vaccination Syndrome: A Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- PAC-19QoL Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •History of Schizophrenia
- •Currently using antidepressant medication
结局指标
主要结局
PAC-19QoL Questionnaire
时间窗: 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
时间窗: 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.
次要结局
- 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")
- Resting Heart Rate Variability(From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months")
- Heart rate variability during 6MWT(From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months")
- Resting Heart Rate(From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months")
- Heart Rate during 6MWT(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(From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months")
- Total Cholesterol(From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months")
- HDL-Cholesterol(From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months")
- LDL-Cholesterol(From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months")
- Triglycerides(From enrollment to an interim measurement at 1.5 months to the end of treatment at 3 months")