Short-term Intervention With Nitrate-based Nutritional Formula on Oxygen Saturation and Patient-reported Outcomes in Covid-19 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in oxygen saturation
研究概览
简要总结
A preliminary open-label case report demonstrated the beneficial effects of an innovative nitrate-based nutritional formula on oxygen saturation in patients with COVID-19. Whether these initial findings are relevant in a more robust research design currently remains unknown. Therefore, the main objective of this randomized controlled trial was to analyze the acute effects of nitrate-based nutritional formula on peripheral SpO2, patient-reported outcomes, and safety indices in patients with acute COVID-19 infection.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 3 18 years
- •confirmed SARS-CoV-2 infection
- •SpO2 < 95%
- •COVID-19 patients in stable condition (i.e., not requiring hospital admission)
排除标准
- •regnant or lactating women
- •concomitant pulmonary and cardiovascular conditions
- •history of dietary supplement use during the past four weeks
- •participation in another COVID-19-related study
- •unwillingness to give informed consent
研究组 & 干预措施
PLACEBO
Placebo (2.5 grams of inulin)
干预措施: PLACEBO (Dietary Supplement)
NITRATE
Multi-component nutritional formula (containing 1200 mg of potassium nitrate, 200 mg of magnesium, 50 mg of zinc, and 1000 mg of citric acid)
干预措施: NITRATE (Dietary Supplement)
结局指标
主要结局
Change in oxygen saturation
时间窗: Baseline vs. 72 hours post-intervention
Measured at baseline and 72 hours post-intervention
次要结局
- Change in fatigue(Baseline vs. 72 hours post-intervention)
研究者
Sergej Ostojic
Head of Applied Bioenergetics Lab
University of Novi Sad, Faculty of Sport and Physical Education