Effect of Vitamin D Supplementation on the Development of Respiratory Infections (COVID-19) in Health Personnel at Hospital Clínica NOVA With Serum Values> 20ng / ml
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Number of participants with Influenza A infection with Vitamin D3 > 20ng/ml
研究概览
简要总结
Scarce information exists in relation to the effect of supplementation of Vitamin D3 in SARS-COV-2 infection, H1N1, and A, B Influenza when 25-hydroxyvitamin levels are between 20-100ng/ml. This study will evaluate the effect of supplementation of vitamin D3 vs. dietary-hygiene measures in SARS-COV-2 , H1N1, A, B Influenza infection rate in patients with serum 25-hydroxyvitamin D3 levels >20ng/ml.
A comparative randomized study that will evaluate the effect of a monthly supplementation with 52000 units of Vitamine D3 during three months vs hygienic-dietary measures in the development of respiratory infections such as COVID-19, H1N1, A, B Influenza during 6 months of follow-up in health workers from a hospital in Northern Mexico with serum vitamin D values +/- 20ng/ml. Also, patients that during screening have 25-hydroxyvitamin D3 levels <20 ng/ml will receive vitamin D supplementation according to primary care discretion for three months and will be followed for 6 months and infection rate will be analyzed and compared.
详细描述
COVID-19 is an infectious disease caused by the newly discovered coronavirus SARS-CoV-2, with a clinical spectrum from asymptomatic infection to critical and fatal illnesses. Influenza H1N1, A, and B have also been the most frequent etiologies of respiratory tract infection that are usually affected during the winter season before COVID-19 pandemic.
There is controversy against Vitamin D3 supplementation in the prevention of respiratory tract infections. A previous meta-analysis has demonstrated an association between vitamin D3 levels <20mg/dl and a higher risk of infection. There is less information in relation to the effect of supplementation when vitamin levels are between 20-100ng/ml and the prevention of infection.
The rationale of this study will be to find a relationship between vitamin D3 supplementation and the incidence of SARS-CoV-2 or Influenza H1N1, A, or B infection through a prospective study. Vitamin D3 could have a role in innate and adaptive immunity that could help prevent this disease. The target population will be health workers with a high risk of SARS-COV-2 or influenza infection with vitamin D > 20 ng/ml.
The primary aim is to evaluate the effect of vitamin D3 supplementation vs. dietary-hygiene measures in developing SARS-COV-2 infection, Influenza H1N1, A or B in patients with serum 25-hydroxyvitamin D3 >20 ng/ml.
A secondary aim will be to compare a group of hospital workers with serum 25-hydroxyvitamin D3 < 20 ng/ml that could or not have been supplemented with Vitamin D3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-90 years
- •Both genders
- •Absence of infection by COVID-19, influenza H1N1, influenza A or B at the time of measurement of serum vitamin D levels.
- •Absence of infection at any site of bacterial, fungal or other origins
- •Health worker at Hospital Clínica Nova.
排除标准
- •for both arms:
- •Serum Vitamin D levels> 100ng / ml
- •Previous consumption of supplements containing Vitamin D3
- •Pregnancy
结局指标
主要结局
Number of participants with Influenza A infection with Vitamin D3 > 20ng/ml
时间窗: 6 months
Evaluate the number of patients that get infected by Influenza A with vitamin D3 levels +/- 20ng/ml that receive supplementation or diet or hygiene measures
Number of participants with Influenza H1N1 infection with Vitamin D3 > 20ng/ml
时间窗: 6 months
Evaluate the number of patients that get infected by H1N1 infection with vitamin D3 levels +/- 20ng/ml that receive supplementation or diet or hygiene measures
Number of participants with Covid-19 Infection with Vitamin D3 > 20ng/ml
时间窗: 6 months
Evaluate the number of patients that get infected by COVID-19 during study period with vitamin D3 levels \>20ng/ml that receive supplementation or diet and hygiene measures
Number of participants with Influenza B infection with Vitamin D3 > 20ng/ml
时间窗: 6 months
Evaluate the number of patietns that get infected by Influenza B with vitamin D3 levels +/- 20ng/ml that receive supplementation or diet or hygiene measures
次要结局
- Number of participants with influenza A Infection with Vitamin D3 < 20ng/ml(6 months)
- Number of participants with H1N1 infection Infection with Vitamin D3 < 20ng/ml(6 months)
- Number of participants with Covid-19 Infection with Vitamin D3 < 20ng/ml(6 months)
- Number of participants with influenza B Infection with Vitamin D3 < 20ng/ml(6 months)
研究者
Maria Elena Romero Ibarguengoitia
Principal Investigator/Research Director
Hospital Clinica Nova