Older Medical Patients
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTZinc Supplement
22 mg Zinc supplementation daily for 12 months
Sponsors
Herlev Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* above 65 years old included in ZOOM out ( clinical trials no: NCT07367412) * admittet at the medical emergency department Herlev Hospital
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| inflammation 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood samples indicating metabolic status and risk factors | 3 month, 6 month, 12 month | Between group difference in change in triglycerids (mmol/L) |
| Patient reported Outcomes | 3,6, and 12 months | Between group difference in change in Quality of life measured with EQ5D, and selfreported infections assessed with a homemaid, not validated questionnare. |
| Bodycomposition | 3, 6, and 12 months | 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 |
| Physical performance | 3,6, and 12 month | between group difference in change in chair stand test 30second |
| Nutrition and zinc intake | 3,6, and 12 months | estimating zinc intake using 24 hour recall assessment of nutritional intake. Assessing nutritional status with the Patient Generated Subjective Global Assessment (PG-SGA) |
| Inflammation changes at 12 months | 3, 6, and 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) |
| 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 | Evaluating the best way to assess zinc status in humans, and the association to occurring infections and readmissions |
Contacts
CONTACTCecilia M Lund, MD, PhD
Outcome results
None listed