Effect of Zinc Supplementation on Occurrence of Infections in Older Medical Patients (ZOOM) - a Cluster Randomized Controlled Trial (ZOOM OUT).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 2
- 主要终点
- Days Alive and Out of Hospital
研究概览
简要总结
The goal of this clinical trial is to learn about the effect of zinc supplementation once daily for 12 months in older acute medical patients. The main question it aims to answer is:
• Can daily zinc supplementation for 12 months increase Days Alive and Out of Hospital (DAOH)? Researchers will compare zinc supplementation to a control group, a group who do not receive zinc supplementation, to see if zinc supplementation can increase Days Alive and Out of Hospital, reduce antibiotic use, readmissions and mortality.
Participants will take 22 mg zinc supplementation once daily for 12 months or not.
The researchers will draw data on readmissions, antibiotic use and mortality during the 12 months follow-up period.
详细描述
- Study purpose Older adults are at increased risk of micronutrient deficiencies, including zinc, due to sparse food intake. Zinc deficiency is known to increase the susceptibility to infections, further exacerbating the vulnerability of older adults to health complications. Infections are common among older adults and are a leading causes of acute hospital admissions and readmissions.
The hypothesis is that zinc supplementation for older acutely admitted medical patients can increase Days Alive and Out of Hospital regardless of baseline plasma zinc level
Objectives:
Primary objective: To test in older acute medical patients if zinc supplementation once daily for 12 months can increase Days Alive and Out of Hospital.
Secondary objectives: To evaluate if zinc supplementation once daily can reduce antibiotic use, readmissions and mortality during the 12 months follow-up period. 2. Short background A large proportion of older adults are malnourished, which can lead to increased morbidity, mortality, prolonged hospitalization and reduced quality of life (QoL). With malnutrition the patient lacks vitamins and minerals, including zinc, which is essential for older adults. Early detection and treatment of malnutrition has been shown to be beneficial for patients, including reducing length of stay in the hospital. The older adults are at increased risk of zinc deficiency, with less than half of the free-living older adults having a sufficient zinc intake. Zinc is essential for immune function and acute deficiency weakens both innate and adaptive immunity, increasing susceptibility to infections. The effects of zinc supplementation on infections are conflicting, some studies do not find an effect of zinc supplementation in patients with infections, while other studies of healthy or institutionalized older adults, found that zinc supplementation significantly reduce the incidence of infections, antibiotic use and prevention of symptomatic COVID-19. Despite previous findings, the effect of zinc supplementation has not been studied in older acutely admitted medical patients on a large scale. 3. Method This study is a cluster randomized controlled trail. A total of 8000 patients will be included and divided into three groups. Patients ≥ 65 years, who come to the Medical Emergency Department at Herlev Hospital, and who meet the inclusion criteria, will be offered participations in the study. An automatic pop-up in the patient medical record will appear in blocks of time and will randomly assign patients to intervention with zinc supplementation (intervention n = 1000), recommendation of zinc supplementation (recommendation n = 3000) or control (n = 4000), regardless of plasma zinc levels at admission. The treating doctor will assess if the patient is eligible and include the patient to the study.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All medical patients aged ≥ 65 years assessed at the Medical Emergency Department, Herlev Hospital
排除标准
- •Self-supplementing with zinc at time of assessment (> 10 mg zinc/day)
- •Terminal illness (life expectancy < 6 months, estimated by Clinical Frailty Scale ≥8)
- •Patients receiving parenteral nutrition (partial or complete)
- •Patients treated with hemodialysis or peritoneal dialysis
- •Patients know with known severe dementia
- •Patients who do not understand Danish and patients with temporary civil person registration numbers (CPR)
研究组 & 干预措施
Intervention
The intervention group will consist of 1000 patients who following discharge from the hospital will have daily zinc supplements prescribed and provided free of charge which will be sent to their home for a year.
干预措施: Zinc (zinc sulphate) (Dietary Supplement)
Recommendation group
The recommendation group will consist of 3000 patients who will have zinc supplements recommended and prescribed. However, zinc supplements will not be provided free of charge.
干预措施: Zinc (zinc sulphate) (Dietary Supplement)
Control group
The control group will consist of 4000 patients who will receive usual care
结局指标
主要结局
Days Alive and Out of Hospital
时间窗: During the 12 months follow-up period
To evaluate the differences between the groups in Days Alive and Out of Hospital. The endpoints will include date of death, date of hospitalization, and number of days hospitalized during the 12 months follow-up period in the three groups
次要结局
- Antibiotic use(During the 12 months follow-up period)
- Hospital admissions(During the 12 months follow-up period)
- Readmission due to cardiovascular disease(During the 12 months follow-up period)
- Readmissions due to infections(During the 12 months follow-up period)
- Mortality(During the 12 months follow-up period)
研究者
Cecilia Margareta Lund
Associate Professor
Herlev Hospital