Zinc Supplementation and Inflammation in Older Medical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zinc Supplement.
- Who it may be relevant to
- Registry conditions: Older Medical Patients. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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 supplement Zinc Supplement
22 mg Zinc supplementation daily for 12 months
Primary outcome measures
- inflammation 6 months [Time frame: 6 months]
Secondary outcome measures (11)
- Blood samples indicating metabolic status and risk factors [Time frame: 3 month, 6 month, 12 month]
- Blood samples indicating metabolic status and risk factors [Time frame: 3 month, 6 month, 12 month]
- Blood samples indicating metabolic status and risk factors [Time frame: 3 month, 6 month, 12 month]
- Blood samples indicating metabolic status and risk factors [Time frame: 3 month, 6 month, 12 month]
- Patient reported Outcomes [Time frame: 3,6, and 12 months]
- Bodycomposition [Time frame: 3, 6, and 12 months]
- Physical performance [Time frame: 3,6, and 12 month]
- Physical performance [Time frame: 3,6, and 12 month]
- Nutrition and zinc intake [Time frame: 3,6, and 12 months]
- Inflammation changes at 12 months [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) [Time frame: 3, 6, and 12 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07672132 · ZOOM-IN