ZOOM IN Study: Micronutrient Deficiencies and Effect of Zinc Supplementation on Inflammation and Occurrence of Infections in Older Medical Patients (ZOOM) - A Sub-study of a Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 主要终点
- inflammation 6 months
研究概览
简要总结
The hypothesis is that a daily supplement of 22 mg of zinc over 12 months can reduce in-flammatory biomarkers in acutely hospitalized older adults aged ≥ 65 years.
The aims are to determine, in acutely hospitalized older adults aged ≥ 65 years, if a daily supplement of 22 mg of zinc over 12 months compared to control can decrease inflammato-ry biomarkers, reduce symptoms of self-reported infection, reduce readmission and mortali-ty, increase QoL, increase physical performance, investigate potential adverse events to zinc supplement, and the changes in inflammatory biomarkers. It will also be studied if albumin-corrected zinc in plasma is a more accurate method for assessing zinc status than ordinary plasma zinc.
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
- •above 65 years old included in ZOOM out ( clinical trials no: NCT07367412)
- •admittet at the medical emergency department Herlev Hospital
排除标准
- •Patients receiving zinc supplements (>10 mg daily) at time of inclusion
- •Patients with 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 known with severe dementia
- •Patients who do not understand Danish and patients with temporary civil person registration numbers (CPR)
结局指标
主要结局
inflammation 6 months
时间窗: 6 months
To evaluate the difference between the groups in plasma concentrations of IL-6 during the first 6-months. Endpoints: Plasma concentration of IL-6 (pg/ml) from baseline to 6 months
次要结局
- Blood samples indicating metabolic status and risk factors(3 month, 6 month, 12 month)
- Patient reported Outcomes(3,6, and 12 months)
- Bodycomposition(3, 6, and 12 months)
- Physical performance(3,6, and 12 month)
- Nutrition and zinc intake(3,6, and 12 months)
- Inflammation changes at 12 months(3, 6, and 12 months)
- Methods for assessing zinc: Free zinc binding capacity(μmol/L) vs. plasma zinc(μmol/L) (with and without adjustments for albumin)(3, 6, and 12 months)
研究者
Cecilia Margareta Lund
Associate Professor
Herlev Hospital