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A clinical trial of the effect of zinc supplementation on the occurrence of tuberculosis immune reconstitution inflammatory syndrome in HIV/TB co-infected patients

Study on the regulatory mechanism of zinc element in immune reconstruction in AIDS patients with tuberculosis infection

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071977
Enrollment
Unknown
Registered
2023-05-30
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

tuberculosis immune reconstitution inflammatory syndrome

Interventions

Zinc supplementation group (intervention group):standard treatment and Zinc supplementation
no zinc supplementation group (control group):standard treatment without zinc supplementation

Sponsors

Shenzhen Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: a. Meet the diagnostic criteria for HIV-1 infection in the "Chinese AIDS Diagnosis and Treatment Guidelines" (2021 edition); b. Meet the national tuberculosis diagnostic criteria; c. Agree to participate in this study and sign an informed consent form after being fully informed; d. Have not received anti-HIV treatment before enrollment; e. Be an adult over 18 years old.

Exclusion criteria

Exclusion criteria: a. Currently undergoing or have started antiretroviral therapy for HIV; b. Have taken zinc supplements in the past month; c. Allergic or contraindicated to zinc and related supplements; d. Excluding children and pregnant women;

Design outcomes

Primary

MeasureTime frame
Incidence rates of two groups of IRIS;Serum zinc concentration;

Secondary

MeasureTime frame
Clinical remission rate of tuberculosis symptoms;safety assessment;

Countries

china

Contacts

Public Contactfang zhao

Shenzhen Third People's Hospital, Second Hospital Affiliated to Southern University of Science and Technology

zhaofang_008@163.com+86 136 7008 1679

Outcome results

None listed

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