Zinc and Selenium Bioactivity

NCT07180329 | Completed DMC

• 1 other identifier: REC-UOL-FAHS/906/2022
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The primary hypothesis of the study was that zinc and selenium supplementation through fortified cookies would enhance the immune response and improve clinical outcomes in tuberculosis patients. For this purpose, a single-blind randomized control trial was carried out to determine the effect of zinc and selenium on the immunomodulatory parameters of tuberculosis approved by the Ethics Committee of the University of Lahore, Pakistan. In the first phase, the proximate and minerals profile of shiitake mushroom was analyzed, and functional cookies were developed fortified with zinc and selenium. In the second phase, 120 tuberculosis patients were divided into four groups (T0, T1, T2 \& T3) to assess the impact of supplementation on anthropometric, microbiological, and hematological parameters. Meanwhile, results were statistically examined through Principal component analysis and a heat map of the attributes under research were generated using R-studio (Version 4.2.2). However, results explained that the therapeutic effect of dosage on anthropometric, microbiological, and hematological measurements showed a significant result (p≤0.05), indicating that zinc and selenium may help to modulate the immunological response, and potentially improving the body's ability to resist tuberculosis.

Conditions

Immunomodulatory Drugs; Tuberculosis

Keywords

Nutrition; tuberculosis; immunomodulatory; mushrooms; fortified

Outcome Measures

Primary Outcomes (2)

• Anthropometric measurements

  Body Mass Index was measured. The formula for Body Mass Index (BMI) is: kg/m\^2.

  5 months

• Determination of MAC, MAMC, and TSF

  The anthropometric measurements of the patients were assessed, including Mid-Arm Circumference (MAC, cm), Mid-Arm Muscle Circumference (MAMC, cm), and Triceps Skinfold Thickness (TSF, mm). These parameters were measured to evaluate the nutritional and muscle status of the patients

  5 months

Secondary Outcomes (1)

• Hematological analysis

  5 months

Study Arms (3)

Control group

PLACEBO COMPARATOR

Patients took Myrin P Fort

Dietary Supplement: Myrin P Fort

Zn + Se supplemented cookies

EXPERIMENTAL

patients took Zn + Se supplemented cookies

Dietary Supplement: Zn + Se + Myrin P Fort

Zn + Se + Myrin P Fort

EXPERIMENTAL

Patients took Zn + Se \+ Myrin P Fort

Dietary Supplement: Zn + Se supplemented cookies

Interventions

Myrin P Fort DIETARY_SUPPLEMENT

Patient took Myrin P Fort

Control group

Zn + Se supplemented cookies DIETARY_SUPPLEMENT

patients took Zn + Se supplemented cookies

Zn + Se + Myrin P Fort

Zn + Se + Myrin P Fort DIETARY_SUPPLEMENT

patients took Zn + Se \+ Myrin P Fort

Zn + Se supplemented cookies

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 30-55 years.
• Confirmed diagnosis of pulmonary tuberculosis (Pul-TB) with positive acid-fast bacilli (AFB) in sputum samples.

You may not qualify if:

• Patients diagnosed with extra-pulmonary TB.
• Patients who had been on anti-TB therapy for more than 2 months prior to enrollment.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Sana Noreen

Lahore, 54000, Pakistan

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 18, 2025
• Study Start: February 1, 2023
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: September 18, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)