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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controlgroup | No Intervention | Standard treatment | |
| Intervention | Active Comparator | 22 mg zinc supplementation daily for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Supplement | Dietary Supplement | 22 mg Zinc supplementation daily for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| inflammation 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood samples indicating metabolic status and risk factors | Between group difference in change in triglycerids (mmol/L) | 3 month, 6 month, 12 month |
| Blood samples indicating metabolic status and risk factors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cecilia M Lund, MD, PhD | Contact | +4538686112 | cecilia.margareta.lund.01@regionh.dk |
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Between group difference in change in cholesterol (mmol/L)
| 3 month, 6 month, 12 month |
| Blood samples indicating metabolic status and risk factors | Between group difference in change in HbA1c (mmol/mol) | 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). | 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. | 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 | 3, 6, and 12 months |
| Physical performance | between group difference in change in chair stand test 30second | 3,6, and 12 month |
| Physical performance | between group difference in change in handgrip strength (kg) | 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) | 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) | 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 | 3, 6, and 12 months |