Prevent and Treat Double-Blind Factorial Randomized Trials of Daily Oral Vitamin D, Omega 3, and Combination Vitamins B, C and Zinc Supplementation for the Treatment and Prevention of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Covid infection rate (PREVENT Trial only)
研究概览
简要总结
The NUTROVID Factorial Trials
The purpose of the NUTROVID-Prevent and NUTROVID-Treat Factorial Trials is to determine whether Vitamin B Complex, Vitamin C, and Zinc; Vitamin D; and Omega3, taken at dosages approximating recommended dosages, can reduce the risk of COVID-19 infection, hospitalization, mortality.
详细描述
Inadequate vitamin intake is common in Mexico. Vitamin deficiency is hypothesized as a risk factor for COVID-19 infection and severe outcomes. Specifically, Vitamin D has been hypothesized as a regulator of the inflammatory cytokine response; Vitamin C may help reduce the risk of a cytokine storm and support the immune system; Vitamin B reduces pro-inflammatory cytokine levels, helps improve respiratory function, reduces hypercoagulability, and promotes endothelial structural integrity; Resolvins, derived from Omega3s, are a type of specialized pro-resolving lipid autacoid mediators hypothesized to prevent cytokine storms. Elemental Zinc is hypothesized to inhibit the replication of viruses.
The NUTROVID-Prevent and NUTROVID-Treat Factorial Trials are testing the efficacy of these supplements (Vitamins B, C, D, Zinc, and Omega 3) when used over a 60 day period among those who test positive (Treat) and negative (Prevent) for SARS-COV-2 via a PCR test.
The NUTROVID Trials utilize an innovative and cost-efficient approach, leveraging the existing infrastructure of the hospital system in San Luis Potosí province of Mexico. For NUTROVID-Treat, we aim to enroll ~1,800 adults who have recently tested positive for SARS-Cov-2 and who have given informed consent. These ~1,800 adult females and males age 18 or older will be enrolled and randomized into the NUTROVID Treat Factorial Trial's 2x2x2 arms, in which 50% of the population will have a chance to receive any combination of the 3 supplement formulations; the other 50% will receive the respective placebos.
Those who test negative will be randomized into the NUTROVID-Prevent Factorial Trial's 2x2x2 arms, in which 50% of the population will have a chance to receive any combination of the 3 supplement formulations; the other 50% will receive the respective placebos. For NUTROVID-Prevent, we also aim to recruit ~1,800 adults, females and males.
Hospital staff will review medical records for vital events and conduct patient and family follow-up until ~November 2021.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Positive SARS-CoV-2 Test group (Target enrollment: N=1,800) NUTROVID Treat Trial: Adult men/women recently diagnosed with COVID-19 (positive PCR test for SARS-CoV-2 coronavirus) within <=5 days of symptom onset; and satisfying one of these risk factors: >=50 years old; or Diabetic & >=40 years old; or Obese & >=40 years old.
- •Negative SARS-CoV-2 Test group (Target enrollment: N=1,800) NUTROVID Prevent Trial: Adult men/women recently tested negative for COVID-19 (negative PCR test for SARS-CoV-2 coronavirus); and satisfying one of these risk factors: >=50 years old; or Diabetic & >=40 years old; or Obese & >=40 years old.
- •Signed Informed Consent Form
排除标准
- •Patients requiring immediate intubation or deemed likely to die within 48 hours.
- •Patients deemed likely for transfer to an ICU within 48 hours.
- •Patients currently taking oral corticosteroids for any reason at the time of presentation for care.
- •Patients included in any other interventional trial.
- •Uncontrolled bacterial superinfection.
- •Severe chronic kidney disease (stage 4) or requiring dialysis (i.e. eGFR < 30).
- •Pregnant women or women who are breastfeeding.
- •Immunocompromised patients.
- •Any patient with recent treatment (past 30 days) of immunosuppressive agents including (but not restricted to) DMARDs, corticosteroids, antibody therapy, intravenous immunoglobulins etc.
- •Patients with acute myocardial infarction.
研究组 & 干预措施
3 - Vitamin D, Vitamins B, C, Zinc
Vitamin D of F1 Placebo of F2 Vitamins B, C, Zinc of F3
[60 days]
干预措施: Vitamin C, Vitamin B complex and Zinc Acetate (Dietary Supplement)
5 - Omega 3, Vitamins B, C, Zinc,
Placebo of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3
[60 days]
干预措施: Omega DHA / EPA (Dietary Supplement)
5 - Omega 3, Vitamins B, C, Zinc,
Placebo of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3
[60 days]
干预措施: Vitamin C, Vitamin B complex and Zinc Acetate (Dietary Supplement)
6 - Omega 3
Placebo of F1 Omega 3 of F2 Placebo of F3
[60 days]
干预措施: Omega DHA / EPA (Dietary Supplement)
1 - Vitamin D, Omega 3, Vitamins B, C, Zinc
Vitamin D of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3
[60 days]
干预措施: Omega DHA / EPA (Dietary Supplement)
1 - Vitamin D, Omega 3, Vitamins B, C, Zinc
Vitamin D of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3
[60 days]
干预措施: Vitamin C, Vitamin B complex and Zinc Acetate (Dietary Supplement)
2 - Vitamin D, Omega 3
Vitamin D of F1 Omega 3 of F2 Placebo of F3
[60 days]
干预措施: Omega DHA / EPA (Dietary Supplement)
7 - Vitamins B, C, Zinc
Placebo of F1 Placebo of F2 Vitamins B, C, Zinc of F3
[60 days]
干预措施: Vitamin C, Vitamin B complex and Zinc Acetate (Dietary Supplement)
8 - No Interventions
Placebo of F1 Placebo of F2 Placebo of F3
[60 days]
干预措施: Placebo (Other)
3 - Vitamin D, Vitamins B, C, Zinc
Vitamin D of F1 Placebo of F2 Vitamins B, C, Zinc of F3
[60 days]
干预措施: Vitamin D (Dietary Supplement)
4 - Vitamin D
Vitamin D of F1 Placebo of F2 Placebo of F3
[60 days]
干预措施: Vitamin D (Dietary Supplement)
2 - Vitamin D, Omega 3
Vitamin D of F1 Omega 3 of F2 Placebo of F3
[60 days]
干预措施: Vitamin D (Dietary Supplement)
1 - Vitamin D, Omega 3, Vitamins B, C, Zinc
Vitamin D of F1 Omega 3 of F2 Vitamins B, C, Zinc of F3
[60 days]
干预措施: Vitamin D (Dietary Supplement)
结局指标
主要结局
Covid infection rate (PREVENT Trial only)
时间窗: 30 and 60 days
1.a. Incidence of positive PCR at \~1 month and \~2 months; 1.b. Incidence of symptomatic positive PCR and asymptomatic positive PCR at 1 month and 2 months.
Incidence of severe outcome (TREAT Trial only)
时间窗: 1.a. 1-30 days; 1.b. 30-60; 1.c. 30 days to ~November 2021; 1.d. 60 days to ~ November 2021
1.a. Incidence of severe outcome (mortality or ICU admission or intubation) up to 30 days. 1.b. Incidence of severe outcome (mortality or ICU admission or intubation) from 30-60 days. 1.c. Incidence of severe outcome (mortality or ICU admission or intubation), from 30 days to \~ November 2021. 1.d. Incidence of severe outcome (mortality or ICU admission or intubation), from 60 days to \~ November 2021.
次要结局
- Incidence of hospitalization and death (PREVENT Trial only)(1-10 months)
- Length of hospitalization and death after discharge (TREAT Trial only)(2.a. 1-30 days; 2.b. 1 day(s) to ~November 2021, 2.c. 30 days to ~November 2021)
研究者
A Yáñez Admin
On-site Principal Investigator
Hospital de la Soledad