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临床试验/NCT07672132
NCT07672132尚未招募不适用

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

Herlev Hospital0 个研究点目标入组 220 人开始时间: 2026年6月2日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cecilia Margareta Lund

Associate Professor

Herlev Hospital

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