Randomized Clinical Trial: IS Zinc and Zinc Ionophere EGCG as Supplement Improve Outcome of Active Pulmonary Tuberculosis

NCT05116098 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: tuberculosis treatment
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tuberculosis is still global burden disease at all the word and effect on quality life of patients and affect on health authorities because the cost of medicine and health cost .

• A total of 1.4 million people died from TB in 2019 (including 208 000 people with HIV). Worldwide, TB is one of the top 10 causes of death and the leading cause from a single infectious agent (above HIV/AIDS).
• In 2019, an estimated 10 million people fell ill with tuberculosis (TB) worldwide. 5.6 million men, 3.2 million women and 1.2 million children. TB is present in all countries and age groups. But TB is curable and preventable.
• In 2019, 1.2 million children fell ill with TB globally. Child and adolescent TB is often overlooked by health providers and can be difficult to diagnose and treat.
• In 2019, the 30 high TB burden countries accounted for 87% of new TB cases. Eight countries account for two thirds of the total, with India leading the count, followed by Indonesia, China, the Philippines, Pakistan, Nigeria, Bangladesh and South Africa. ( WHO) All TB cases and 92.5% controls were zinc deficient. The odds of TB cases with deficiencies of vitamin A and zinc was 2.3 (95% CI: 1.1 to 4.8) times more likely as compared to the controls. More than 80% of all participants had below average fulfilment of energy and vitamin A intakes. (7) Zinc is necessary for intact immune health and defense against infection but there are common health problem deficiency at developing countries and so zinc needs as supplement and the second problem zinc need helper for transfer through plasma membrane so zinc ionophore is a best solution as this problem so the investigators can use zinc ionophore as helper for zinc to enter the cells for autophagy

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• sputum analysis at start of treatment and after one month

  percentage of conversion sputum samples converted from positive to negative after one month

  6 month

Secondary Outcomes (3)

• measurement of serum or plasma zinc at all participants

  6 month

• measurement of serum interleukin 6

  6 month

• serum Adenosine deaminase (ADA)

  6 month

Study Arms (2)

100 pulmonary positive patients on tb protocol adding to supplement zinc 50 mg 400 mg once daily

ACTIVE COMPARATOR

Combination Product: zinc 50 mg + Epigallocatechin gallate

control group 100 patients only on tuberculosis national protocol

PLACEBO COMPARATOR

Combination Product: zinc 50 mg + Epigallocatechin gallate

Interventions

zinc 50 mg + Epigallocatechin gallate COMBINATION_PRODUCT

ZINC 50 MG and EGCG 200mg oral daily for 1 month

100 pulmonary positive patients on tb protocol adding to supplement zinc 50 mg 400 mg once daily; control group 100 patients only on tuberculosis national protocol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• new diagnosed pulmonary positive t.b patients
• age above 18 years
• any patients with HIV and immuncromoised with t.b patients
• patients with covid 19 and t.b
• patients with drug t.b resistant
• male or female
• all races African or Asian or white -

You may not qualify if:

• less than 18 years 2- pregnant female 3- on another supplement

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead

MeSH Terms

Conditions

Tuberculosis

Interventions

Zinc; epigallocatechin gallate

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ministry of Health, Saudi Arabia

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: November 10, 2021
• Study Start: November 30, 2021
• Primary Completion: June 30, 2022
• Study Completion: November 30, 2022
• Last Updated: November 10, 2021

Record last verified: 2021-11