NCT04751669已完成不适用
Efficacy of Micronutrient Dietary Supplementation in Reducing Hospital Admissions for COVID-19: A Double-blind, Placebo-controlled, Randomized Clinical Trial
Fundació Institut Germans Trias i Pujol2 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2021年8月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Need for hospital admission
研究概览
简要总结
A double-blind, placebo-controlled, randomized clinical trial to assess efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19 and incidence of Long Covid.
We want to assess the need for hospital admission for severe acute respiratory syndrome Corona Virus-2 (SARS-CoV-2) infection in outpatients diagnosed of COVID-19 disease, taking a micronutrient supplementation for 14 days. The outcome Will be measured within 1 month after beginning the study treatment. The patients will be followed-up for a period of 180 days for the incidence of Long Covid
详细描述
- Type of study/ Design: Randomized, double-blind, placebo-controlled clinical trial.
- Sponsor: Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol / Hospital Universitari Germans Trias i Pujol ( IGTP / HUGTIP)
- Title of the clinical trial: Efficacy of micronutrient dietary supplementation in reducing hospital admissions for COVID-19 and Long Covid: A double-blind, placebo-controlled, randomized clinical trial.
- Protocol code: CoVIT Clinical Trial
- NºClinicaltrials.gov: Pending
- Coordinating researcher: Dra. Teresa-Maria Tomasa-Irriguible.
- Recruiting Center: Germans Trias i Pujol University Hospital (HUGTIP)
- Ethical Committee for clinical Investigation (CEI): Germans Trias i Pujol University Hospital CEI.
- Monitoring: Clinical Research Associate at UPIC (Unitat Polivalent d'Investigació Clínica) Clinical Trial Unit- IGTP
- Study treatments: Dietary supplement with micronutrients and Placebo
- Test phase: Not applicable.
- Main objective: Evaluation of the effectiveness of supplementation with a dietary supplement to improve the need for hospital admission for SARS-CoV-2 infection, and incidence of Long Covid.
- Study pathology: COVID-19.
- Main variable: The need for hospital admission of SARS-CoV-2 documented infection and the incidence of Long Covid
- Study population and total number of patients: Patients of the health system of the Northern Metropolitan Area of Catalan Health Institution with symptoms compatible with SARS-CoV-2 infection. A total of 300 people (150 treated with dietary supplement and 150 with placebo).
- Duration of treatment: 14 days.
- Patients follow-up: 180 days
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo tablets with the same external aspect than the dietary supplement, the same administration route, containing only the excipients
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
- 否
入选标准
- •Informed Consent Form signed.
- •Patients with symptoms compatible with COVID-19: cough and fever who not fulfil criteria of hospitalization and will be in outpatient care.
- •Positive polymerase chain reaction (PCR) or transcription-mediated amplification (TMA) test or rapid antigen test for severe acute respiratory syndrome Corona Virus-2 (SARS-CoV-2) or diagnostic test available.
- •Age ≥ 18 years
- •Availability to meet the requirements of the protocol.
排除标准
- •Intake of any micronutrient supplement during the month prior to inclusion.
- •Patients fulfilling hospitalization criteria.
- •Previous allergies to the micronutrient components and excipients.
- •Age ≥ 90 years with any comorbidity (diabetes, hypertension, obesity, heart disease, respiratory disease)
- •Participation in other research that requires experimental intervention (does not include observational studies) in the previous month before signing the informed consent form.
- •Detection by the researcher of lack of knowledge or willingness to participate and comply with all the requirements of the protocol.
- •Any other findings that at the discretion of the researcher may compromise protocol performance or significantly influence the interpretation or results of the effects of the nutritional supplement
- •Pregnancy or breastfeeding
结局指标
主要结局
Need for hospital admission
时间窗: From baseline to 1 month after beginning the study treatment
The need for hospitalization of documented SARS-CoV-2 infection (positive polymerase chain reaction or transcription-mediated amplification test or antigen test or positive serology or diagnostic test available) over the course of the disease
Incidence of Long Covid.
时间窗: 6 months after beginning the study treatment
Incidence of long Covid or symptoms persistence following World Health Organization definition
次要结局
- Micronutrient basal status (Vitamin B12)(Within day 1 at study inclusion)
- Micronutrient basal status (Vitamin A and Vitamin E)(Within day 1 at study inclusion)
- Micronutrient status at hospital admission (Iron, Zinc and Copper)(Within the first day of hospital admission)
- Micronutrient status at hospital admission (Vitamin C)(Within the first day of hospital admission)
- Micronutrient basal status (Iron, Zinc and Copper )(Within day 1 at study inclusion)
- Micronutrient basal status (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid(Within day 1 at study inclusion)
- Micronutrient status at end of study (Vitamin A and Vitamin E)(Within 90 days of the study treatment ending)
- Micronutrient status at end of study (Selenium)(Within 90 days of the study treatment ending)
- Thromboembolic disease(From baseline to 30 days of the study treatment ending)
- Death(From baseline to the study follow-up period: Maximum 3 months)
- Intensive Care Unit Admission(From baseline to the study follow-up period: Maximum 3 months)
- Hospitalization needs (days)(From baseline to the study follow-up period: Maximum 3 months)
- Adverse events(From baseline to the study follow-up period: Maximum 3 months)
- Micronutrient basal status (Selenium )(Within day 1 at study inclusion)
- Micronutrient status at hospital admission ( Vitamin B12)(Within the first day of hospital admission)
- Micronutrient status at hospital admission (Selenium)(Within the first day of hospital admission)
- Micronutrient status at end of study (Vitamin B12)(Within 90 days of the study treatment ending)
- Micronutrient status at end of study (Iron, Zinc, and Copper)(Within 90 days of the study treatment ending)
- High-Flow oxygen supplementation(From baseline to the study follow-up period: Maximum 3 months)
- Invasive mechanical ventilation(From baseline to the study follow-up period: Maximum 3 months)
- Cumulative hospital admission(From baseline to the study follow-up period: Maximum 3 months)
- Survival(From baseline to the study follow-up period: Maximum 3 months)
- Serious Adverse Events(From baseline to the study follow-up period: Maximum 3 months)
- Cognitive status(At baseline and at Day 180.)
- Micronutrient basal status (Vitamin C)(Within day 1 at study inclusion)
- Micronutrient status at hospital admission (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)(Within the first day of hospital admission)
- Micronutrient status at hospital admission (Vitamin A and Vitamin E)(Within the first day of hospital admission)
- Oxygen supplementation(From baseline to the study follow-up period: Maximum 3 months)
- Tracheostomy(From baseline to the study follow-up period: Maximum 3 months)
- Renal replacement(From baseline to the study follow-up period: Maximum 3 months)
- Micronutrient status at end of study (Vitamin B1, Vitamin B6, 25-OH-Vitamin D and Folic Acid)(Within 90 days of the study treatment ending)
- Micronutrient status at end of study (Vitamin C)(Within 90 days of the study treatment ending)
- Inflammatory parameters(From baseline to 30 days of the study treatment ending)
- Persistence (or not) of Covid-19 Clinical Symptoms (directly asking patient for peristence of Neurologic, Psicologic, Digestive, Cardiovascular, Respiratory and Osteomuscular Symptoms).(From baseline to the study follow-up period: Maximum 6 months.)
- EQ-5D(At baseline and at Day 180.)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effectiveness of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Environmental EnteropathyEnvironmental EnteropathyNCT01593033Washington University School of Medicine225
招募中
不适用
Clinical Trial on a Food Supplement With Melatonin and Herbal Products to Improve Sleep QualitySleep DisordersNCT05459272Uriach Consumer Healthcare50
已完成
不适用
Possible Effects of the Dietary Supplement Magnesium Compared to PlaceboHealth PromotionNCT06332248Dan Hasson1,013
已完成
不适用
Study to Evaluate the Safety and Efficacy of a Proprietary "Joint Health" Dietary Supplement in Subjects With Joint and Connective Tissue PainJoint PainNCT03209895U.S. Nutraceuticals, LLC135
已完成
2 期
Effectiveness of a Micronutrient Supplement to Lower Plasma Homocysteine MDEG2 Pilot Supplementation TrialMicronutrient DeficienciesHyperhomocysteinemiaNCT03431597London School of Hygiene and Tropical Medicine298