Tests omega-3 fatty acids added to standard treatment for lung tuberculosis
Tests omega-3 supplements against a placebo in adults with newly diagnosed lung tuberculosis.
Plain-language title generated from the registry record
Registry title: Effects of Adjunct Omega-3 Long Chain Polyunsaturated Fatty Acids in Pulmonary Tuberculosis Patient: an Early Bactericidal Activity and Inflammatory Trial
Key facts
- Where
- Klerksdorp, South AfricaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT07118059, who can take part
Where in South Africa
- Perinatal HIV research Unit (Matlosana)Klerksdorp, South AfricaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- North-West University, South Africa
- Trial code
- NCT07118059
- Record updated
- 9 September 2026
- Original description
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.Read full original descriptionShow less
Effects of Adjunct Omega-3 Long-chain Polyunsaturated Fatty Acids in Pulmonary Tuberculosis Patients: An Early Bactericidal Activity and Inflammatory Activity Trial
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
Inclusion: 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: 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; 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); Are currently using omega-3 or omega-6 supplements and are unwilling to stop for the duration of the study; Comorbid condition with treatment of NSAIDS is indicated; Have a known allergy or sensitivity to fish or fish oil; Have any other medical condition or situation that, in the investigator's opinion, may interfere with protocol adherence or data interpretation; 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; 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; Institutionalized or incarcerated individuals; Pregnant or breastfeeding women or women who become pregnant in the first 4 weeks of the trial will be withdrawn; Report high-risk alcohol use (average >4 units/day or binge drinking patterns); Plan to relocate from the study area within the next 3 months.