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

Primary Purpose

Tuberculosis

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
zinc 50 mg + Epigallocatechin gallate
Sponsored by
Ministry of Health, Saudi Arabia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tuberculosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. new diagnosed pulmonary positive t.b patients
  2. age above 18 years
  3. any patients with HIV and immuncromoised with t.b patients
  4. patients with covid 19 and t.b
  5. patients with drug t.b resistant
  6. male or female
  7. all races African or Asian or white -

Exclusion Criteria:

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

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    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

    Arm Description

    Outcomes

    Primary Outcome Measures

    sputum analysis at start of treatment and after one month
    percentage of conversion sputum samples converted from positive to negative after one month

    Secondary Outcome Measures

    measurement of serum or plasma zinc at all participants
    measurement of serum interleukin 6
    measurement of serum interleukin 6
    serum Adenosine deaminase (ADA)
    measurement of serum Adenosine deaminase (ADA)

    Full Information

    First Posted
    October 20, 2021
    Last Updated
    November 1, 2021
    Sponsor
    Ministry of Health, Saudi Arabia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05116098
    Brief Title
    Randomized Clinical Trial: IS Zinc and Zinc Ionophere EGCG as Supplement Improve Outcome of Active Pulmonary Tuberculosis
    Official Title
    Randomized Clinical Trial: IS Zinc and Zinc Ionophere EGCG as Supplement Improve Outcome of Active Pulmonary Tuberculosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 30, 2021 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    November 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ministry of Health, Saudi Arabia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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
    Detailed Description
    M. tuberculosis -infected PMs, in vitro, elaborated IL-6 as the only major cytokine, which was significantly inhibited by anti-TB drugs. Therefore, IL-6 can be developed as a potential biomarker or biosignature to assess the success of the treatment of TB. (1) Tuberculosis is a global health problem, and there is even an increase in cases of multidrug-resistant tuberculosis in the world. Therefore, research is needed that can find new anti-tuberculosis drugs (OAT) that are more effective for tuberculosis treatment. In this study, the effect of (-)-epigallocatechin-gallate (EGCG) of tea leaves (Camellia sinensis) combined with the first-line OAT will be observed, in order to find out whether EGCG has anti-tuberculosis activity and can increase the potential of first-line OAT in-vitro. The anti-tuberculosis activity of EGCG was determined by broth dilution method using Middlebrook 7H9 media at concentration of 50, 100, 150, dan 200 ppm, then the potential of first-line OAT before and after combined with the EGCG was observed. The results showed that the activity of EGCG at concentration 50 ppm and 100 ppm could inhibit the Mycobacterium tuberculosis growth by 80%, at concentration 150 ppm by 90%, and at concentration 200 ppm by 100%. First-line OAT activity before combined with EGCG was ≥ 90% at 5 ppm rifampicin, 0.5 ppm isoniazid, 50 ppm pyrazinamide, and 5 ppm ethambutol. Whereas after combined with EGCG, the potential of each drug increased, marked by anti-tuberculosis activity achieved ≥ 90% at lower concentrations, i.e. rifampicin 0.5 ppm, isoniazid 0.25 ppm, pyrazinamide 20 ppm, and ethambutol 2 ppm. These results indicated that the potential of each first-line OAT increases after being combined with EGCG, and EGCG has potentiation effect when combined with those drugs. In conclusion, EGCG can increase the first-line OAT activity (2) The down-regulation of TACO gene expression by epigallocatechin-3-gallate was accompanied by inhibition of mycobacterium survival within macrophages as assessed through flow cytometry and colony counts. Based on these results, the investigators propose that epigallocatechin-3-gallate may be of importance in the prevention of tuberculosis infection. (3) The effectiveness of anti-tuberculosis treatment was improved during the first two months by vitamin A and zinc supplementation," Dr. Clive E. West, a professor in the department of nutrition at Wageningen University in the Netherlands, and colleagues write in the April issue of the American Journal of Clinical Nutrition (2002;75:720-727). Previous research has shown that TB patients often suffer from malnutrition, which can weaken immune response and increase disease susceptibility. The addition of vitamin A and zinc has been observed to boost the immune response in these patients. Patients who received the supplements were twice as likely to have eliminated the TB bacteria from the mucus coughed up from their lungs by two weeks than the group receiving only standard drug treatment, and maintained that difference for seven weeks. These patients also had a greater reduction in abnormalities or lesions on their chest x-rays than those not taking the supplements. Reducing the amount of potentially contagious bacteria present in patients' sputum would cut the rate at which they spread TB to others, the researchers noted. (4) The effect of green tea extract supplementation on sputum smear conversion and weight changes in pulmonary TB patients: A randomized controlled trial (5) Zinc is an essential micronutrient (34, 40-42), and its tissue and plasma levels are influenced by dietary intake (38, 42). While severe zinc deficiency is rare in the developed world, moderate zinc deficiency is widespread, concentrated in elderly populations (42-45), and can be exacerbated in critically ill patients (33, 46-49). the investigators demonstrate that both genetic MT deficiency and dietary zinc deficiency potentiate lung injury in mechanically ventilated mice, consistent with an essential role for the zinc/MT system in protecting the lung from injurious stretch. To demonstrate clinical relevance of our findings, the investigators show that humans who go on to develop ARDS exhibit lower plasma zinc levels. Taken together, our results suggest that failure of essential stretch-adaptive responses, in this case associated with a remediable dietary deficiency among hospitalized patients, may play an important role in injury responses propagated by MV. (6)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tuberculosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    100 pulmonary positive patients on tb protocol adding to supplement zinc 50 mg 400 mg once daily
    Arm Type
    Active Comparator
    Arm Title
    control group 100 patients only on tuberculosis national protocol
    Arm Type
    Placebo Comparator
    Intervention Type
    Combination Product
    Intervention Name(s)
    zinc 50 mg + Epigallocatechin gallate
    Intervention Description
    ZINC 50 MG and EGCG 200mg oral daily for 1 month
    Primary Outcome Measure Information:
    Title
    sputum analysis at start of treatment and after one month
    Description
    percentage of conversion sputum samples converted from positive to negative after one month
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    measurement of serum or plasma zinc at all participants
    Time Frame
    6 month
    Title
    measurement of serum interleukin 6
    Description
    measurement of serum interleukin 6
    Time Frame
    6 month
    Title
    serum Adenosine deaminase (ADA)
    Description
    measurement of serum Adenosine deaminase (ADA)
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 - Exclusion Criteria: 1- less than 18 years 2- pregnant female 3- on another supplement -

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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