Effects of Zinc Supplementation on Improving Immune Function in Patients with Sepsis

JRCT ID: jRCTs051220200

Registered date:23/03/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Sepsis
• Date of first enrollment: 23/03/2023
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Zinc replacement therapy
Novelzine 100 mg daily: 50 mg twice daily for 7 days.

Outcome(s)

• Primary Outcome: Peripheral blood lymphocyte count at Day15

Secondary Outcome

Peripheral blood lymphocyte count at each time point (Day1,8,29)
N/L ratio at each time point (Day1,8,15,29)
Peripheral blood zinc concentration at each time point (Day1,8,15,29)
Peripheral blood copper concentration at each time point (Day1,8,15,29)
Safety endpoints (disease Safety endpoints (disease, etc.)

Samples should be collected for preservation so that functional analysis of lymphocytes can be performed as an exploratory position.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age 18 years or older at the time consent is obtained.
2) Any gender.
3) Meet the sepsis criteria of SEPSIS-3.
4) Written consent for this study was obtained from the subject or a surrogate.
5) Patients who are expected to survive for 2 weeks.

Appendix: SEPSIS3 Sepsis Criteria
Suspected infection and an increase in total SOFA score of at least 2 points

Exclude criteria

1) Patients with a history of hypersensitivity to the study drug
2) Patients with cardiopulmonary arrest at the time of admission
3) Patients who do not wish to undergo active treatment at the time of diagnosis at the request of the patient or family
4) Patients deemed inappropriate for study inclusion by the principal investigator
5) Patients on immunosuppressive drugs
6) Patients using drugs that affect lymphocyte counts

Related Information

• Primary Sponsor: Inoue Shigeaki