Effects of adjunct Omega-3 long-chain polyunsaturated fatty acids in pulmonary tuberculosis patients: an early bactericidal activity and inflammatory activity trial
NCT ID NCT07118059
First seen Sep 09, 2026 · Last updated Sep 09, 2026
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
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Perinatal HIV research Unit (Matlosana)
RECRUITINGKlerksdorp, North West, 2571, South Africa
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