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NCT Number: NCT07672132

Zinc Supplementation and Inflammation in Older Medical Patients

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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Key information

Conditions

Older Medical Patients

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Zinc Supplement

Dietary Supplement

22 mg Zinc supplementation daily for 12 months

Primary outcomes

  1. inflammation 6 months

    Time frame: 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 outcomes

  1. Blood samples indicating metabolic status and risk factors

    Time frame: 3 month, 6 month, 12 month

    Between group difference in change in triglycerids (mmol/L)

  2. Blood samples indicating metabolic status and risk factors

    Time frame: 3 month, 6 month, 12 month

    Between group difference in change in cholesterol (mmol/L)

  3. Blood samples indicating metabolic status and risk factors

    Time frame: 3 month, 6 month, 12 month

    Between group difference in change in HbA1c (mmol/mol)

  4. Blood samples indicating metabolic status and risk factors

    Time frame: 3 month, 6 month, 12 month

    Between group difference in change in albumin corrected zinc (μmol/L).

  5. Patient reported Outcomes

    Time frame: 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.

  6. Bodycomposition

    Time frame: 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

  7. Physical performance

    Time frame: 3,6, and 12 month

    between group difference in change in chair stand test 30second

  8. Physical performance

    Time frame: 3,6, and 12 month

    between group difference in change in handgrip strength (kg)

  9. Nutrition and zinc intake

    Time frame: 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)

  10. Inflammation changes at 12 months

    Time frame: 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)

  11. 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

    Evaluating the best way to assess zinc status in humans, and the association to occurring infections and readmissions

Study contacts

Contact information is provided by the study sponsor or research team.

Cecilia M Lund, MD, PhD

CONTACT

[email protected]

+4538686112

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study 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

Acronym: ZOOM-IN

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.