Effects of Adjunct Omega-3 Long Chain Polyunsaturated Fatty Acids in Pulmonary Tuberculosis Patient: an Early Bactericidal Activity and Inflammatory Trial

Summary

The goal of this randomized controlled trial is to evaluate the early bactericidal activity, early inflammatory response, and safety of omega-3 long chain polyunsaturated fatty acid (n-3 PUFA) supplementation in adult patients (aged 18- 45 years) with newly diagnosed, bacteriologically confirmed drug-sensitive pulmonary tuberculosis.

The main questions it aims to answers are:

* Does adjunct n-3 LCPUFA supplementation reduce the sputum culture time to positivity
* Does it improve inflammatory markers and TB treatment outcomes compared to placebo Researchers will compare daily supplementation with \~2g n-3 LCPUFA (EPA and DHA ) to placebo (high linoleic sunflower oil) to determine effects on bactericidal activity, inflammation, and clinical outcomes.

Participants will:

* Be randomly assigned to receive either n-3 LCPUFA or Placebo daily for 8 weeks with the intensive phase of TB treatment
* Attend clinical visit baseline, and follow up visit mostly weekly for 2 months and then monthly for 4 months of the continuous phase of TB treatment
* Provide blood, sputum and urine samples for biomarkers and metabolomic analysis
* Undergo assessments of iron status, body composition and muscle strength

Conditions

• Tuberculosis
• Inflammation Biomarkers
• Liver Function Tests
• Iron Status
• Metabolomics
• Nutritional Status
• Clinical Outcomes

Interventions

DIETARY_SUPPLEMENT

Omega-3 (EPA+DHA)

In this study omega-3 will be the real thing mega omega supreme capsule, it will be used as an adjunct therapy with TB treatment in the intensive phase of treatment. Participant will receive x3, 1g capsules which will provide approximately 2g of EPA and DHA

DIETARY_SUPPLEMENT

Placebo

This group will receive the placebo, which will be 3 x 1g capsules of high linoleic sunflower oil, the sunflower capsules have been encapsulated to match the dimension of the omega 3 supplement. The capsules will also be given as and adjunct to TB treatment of the intensive phase of TB treatment

Sponsors & Collaborators

• Perinatal HIV Research Unit of the University of the Witswatersrand

  collaborator OTHER

• North-West University, South Africa

  lead OTHER

Principal Investigators

• Linda prof · North West University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-31

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• South Africa

Study Locations