Zinc Supplementation and Inflammation in Older Medical Patients
ConditionOlder Medical Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHerlev Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
above 65 years old included in ZOOM out ( clinical trials no: NCT07367412)
admittet at the medical emergency department Herlev Hospital
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Zinc Supplement
Dietary supplement22 mg Zinc supplementation daily for 12 months
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: ControlgroupNo intervention 0 interventions
Group B: InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
6 monthsSecondary outcomes
1
Blood samples indicating metabolic status and risk factors
Between group difference in change in triglycerids (mmol/L)
Time frame
3 month, 6 month, 12 month2
Blood samples indicating metabolic status and risk factors
Between group difference in change in cholesterol (mmol/L)
Time frame
3 month, 6 month, 12 month3
Blood samples indicating metabolic status and risk factors
Between group difference in change in HbA1c (mmol/mol)
Time frame
3 month, 6 month, 12 month4
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 monthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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