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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
22 mg Zinc supplementation daily for 12 months
Herlev Hospital
Herlev, Region Hovedstad, Denmark
RECRUITINGinflammation 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
Time frame: 6 months
Blood samples indicating metabolic status and risk factors
Between group difference in change in triglycerids (mmol/L)
Time frame: 3 month, 6 month, 12 month
Blood samples indicating metabolic status and risk factors
Between group difference in change in cholesterol (mmol/L)
Time frame: 3 month, 6 month, 12 month
Blood samples indicating metabolic status and risk factors
Between group difference in change in HbA1c (mmol/mol)
Time frame: 3 month, 6 month, 12 month
Blood samples indicating metabolic status and risk factors
Between group difference in change in albumin corrected zinc (μmol/L).
Time frame: 3 month, 6 month, 12 month
Patient reported Outcomes
Between group difference in change in Quality of life measured with EQ5D, and selfreported infections assessed with a homemaid, not validated questionnare.
Time frame: 3,6, and 12 months
Bodycomposition
between group difference in change in fat mass (kg) and muscle mass (kg) assessed with Bioimpedance analysis- BIA meassured at Baseline and after 3, 6 and 12 months
Time frame: 3, 6, and 12 months
Physical performance
between group difference in change in chair stand test 30second
Time frame: 3,6, and 12 month
Physical performance
between group difference in change in handgrip strength (kg)
Time frame: 3,6, and 12 month
Nutrition and zinc intake
estimating zinc intake using 24 hour recall assessment of nutritional intake. Assessing nutritional status with the Patient Generated Subjective Global Assessment (PG-SGA)
Time frame: 3,6, and 12 months
Inflammation changes at 12 months
Between group difference in change in IL6 (pg/ml), IL8 (pg/ml), YKL-40 (pg/ml) (IL6 at 6 months are primary outcomes)
Time frame: 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)
Evaluating the best way to assess zinc status in humans, and the association to occurring infections and readmissions
Time frame: 3, 6, and 12 months
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