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NCT07118059

PHASE2

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

Sponsor: North-West University, South Africa

View on ClinicalTrials.gov

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

Official title: Effects of Adjunct Omega-3 Long-chain Polyunsaturated Fatty Acids in Pulmonary Tuberculosis Patients: An Early Bactericidal Activity and Inflammatory Activity Trial

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-08

Completion Date

2026-12

Last Updated

2025-08-12

Healthy Volunteers

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

Inclusion Criteria: * adults aged 18-45 years * laboratory confirmed Pulmonary TB defined as a hard copy of a sputum result detected by WHO recommended assay or mycobacteria culture. * Women of childbearing potential with a negative pregnancy test on enrollment * All participant irrespective of HIV status who consent to have a HIV test during enrollment. Exclusion Criteria: * Comorbid condition with treatment of NSAIDS is indicated * Institutionalized or incarcerated individuals * Those on Multiple drug resistance treatment for more than 4 days within the past 6 months or within 1 month to prior to TB treatment initiation * Pregnant or breastfeeding women or women who become pregnant in the first 4 weeks of the trial will be withdrawn * show lab safety values: AST or ALT \> x3 upper limit of normal (ULN) or Total bilirubin \> 2x the ULN, Neutrophils ≤ 700/mm³, Platelets \< 50,000/mm³, Haemoglobin \< 8 g/dL, Serum creatinine \> 2× ULN. * Are receiving or planning treatment with any of the following in the 3 months before or during the trial: Anticoagulants Immune-modulating therapy (e.g., cancer treatment, oral/inhaled corticosteroids) Antacids or proton pump inhibitors (PPIs) * Have a known allergy or sensitivity to fish or fish oil. * Have a recent history (within 2 years) or current clinical evidence of: Peptic ulcer disease or GI bleeding Coagulopathy or bleeding disorders Kidney or liver disease requiring hospitalisation Cardiovascular disease or significant risk factors for it -Are HIV-positive and meet any of the following: CD4 count \< 100 cells/mm³ Viral load \> 400 copies/mL (if on ART) Not yet on ART but are expected to initiate treatment during the 8-week intervention phase * Report high-risk alcohol use (average \>4 units/day or binge drinking patterns) * Have any other medical condition or situation that, in the investigator's opinion, may interfere with protocol adherence or data interpretation. * Plan to relocate from the study area within the next 3 months. * Are currently using omega-3 or omega-6 supplements and are unwilling to stop for the duration of the study.

Locations (1)

Perinatal HIV research Unit (Matlosana)

Klerksdorp, North West, South Africa