Effect of zinc supplementation on severe head trauma patients

Comparison of zinc supplementation and plasebo on clinical improvement of severe head trauma patients admitted to ICU: A Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016053028176N1

Enrollment

100

Registered

2016-06-23

Start date

2012-08-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe head trauma. Injuries to the head

Interventions

Intervention 1: Intervention: 120 mg zinc elemental (528 mg zinc sulfat) as 20 ml zinc solution that were prepared by the study pharmacist in the Investigative Pharmacy Research Centre affiliated to M

Treatment - Drugs

Intervention: 120 mg zinc elemental (528 mg zinc sulfat) as 20 ml zinc solution that were prepared by the study pharmacist in the Investigative Pharmacy Research Centre affiliated to Mashhad Universit

Control: 20 ml distilled water that were prepared by the study pharmacist in the Investigative Pharmacy Research Centre affiliated to Mashhad University of Medical Sciences Number of use: 2 times per

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Severe head trauma patients; aged between 18 to 65 years; GCS between 6-8 Exclusion criteria: patients undergoing a craniotomy; or with a medical history of liver, respiratory or renal disease; diabetes; hypertension and cardiovascular diseases; blood clotting problems; cancer and ongoing pregnancy; patients whit contraindication of enteral nutrition

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Glasgow outcome score (GCS). Timepoint: First 24 hours of admission, 7th, 16th and 28th day. Method of measurement: GCS table.;Sequential Organ Failure Assessment (SOFA). Timepoint: First 24 h of admission, 7th and 16 th day. Method of measurement: SOFA table.;Zinc plasma concentrations. Timepoint: First 24 hours of admission, 7th and 16th day. Method of measurement: Atomic absorption spectrophotometer.;C-reactive protein (CRP). Timepoint: First 24 hours of admission and 16th day. Method of measurement: CRP ELISA Kit.	—

Measure

Time frame

Glasgow outcome score (GCS). Timepoint: First 24 hours of admission, 7th, 16th and 28th day. Method of measurement: GCS table.;Sequential Organ Failure Assessment (SOFA). Timepoint: First 24 h of admission, 7th and 16 th day. Method of measurement: SOFA table.;Zinc plasma concentrations. Timepoint: First 24 hours of admission, 7th and 16th day. Method of measurement: Atomic absorption spectrophotometer.;C-reactive protein (CRP). Timepoint: First 24 hours of admission and 16th day. Method of measurement: CRP ELISA Kit.

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Secondary

Measure	Time frame
Copper plasma concentrations. Timepoint: first 24 hours of admission, 7th and 16th day. Method of measurement: Atomic absorption spectrophotometer.;Length of hospital stay (LOS). Timepoint: at discharge day. Method of measurement: number of hospitalization days.;Glasgow Outcome Score (GOS). Timepoint: At hospital discharge day. Method of measurement: GOS table.;Erythrocyte sedimentation rate (ESR). Timepoint: First 24 hours of admission and 16th day. Method of measurement: Centrifuged.;White blood cell (WBC) count. Timepoint: First 24 hours of admission and 16th day. Method of measurement: Conunt of WBC with cell counter.;Mortality rate. Timepoint: At hospital discharge day. Method of measurement: Conunt of patients (dead and alive).;Enteral intake and parenteral administered. Timepoint: Daily. Method of measurement: Recods of amounts of intake.	—

Measure

Time frame

Copper plasma concentrations. Timepoint: first 24 hours of admission, 7th and 16th day. Method of measurement: Atomic absorption spectrophotometer.;Length of hospital stay (LOS). Timepoint: at discharge day. Method of measurement: number of hospitalization days.;Glasgow Outcome Score (GOS). Timepoint: At hospital discharge day. Method of measurement: GOS table.;Erythrocyte sedimentation rate (ESR). Timepoint: First 24 hours of admission and 16th day. Method of measurement: Centrifuged.;White blood cell (WBC) count. Timepoint: First 24 hours of admission and 16th day. Method of measurement: Conunt of WBC with cell counter.;Mortality rate. Timepoint: At hospital discharge day. Method of measurement: Conunt of patients (dead and alive).;Enteral intake and parenteral administered. Timepoint: Daily. Method of measurement: Recods of amounts of intake.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamad safarian

Faculty of Medicine, Mashhad University of Medical Sciences

safarianM@mums.ac.ir+98 51 3882 8888

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026