NCT07118059RecruitingPhase 2
Effects of Adjunct Omega-3 Long Chain Polyunsaturated Fatty Acids in Pulmonary Tuberculosis Patient: an Early Bactericidal Activity and Inflammatory Trial
Effects of Adjunct Omega-3 Long-chain Polyunsaturated Fatty Acids in Pulmonary Tuberculosis Patients: An Early Bactericidal Activity and Inflammatory Activity Trial
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 4 Aug 2025
- Start date
- 19 Aug 2026
- Primary completion date
- Nov 2027
- Lead sponsor
- North-West University, South Africa
- Diseases
- Tuberculosis
- NCT number
- NCT07118059
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 19 Aug 2026 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Perinatal HIV research Unit (Matlosana) Coordinator of this site? Confirm its status | Klerksdorp | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.