Omega-3 supplements added to standard TB treatment in adults with pulmonary TB

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized phase 2 study, adults 18–45 years with newly diagnosed bacteriologically confirmed pulmonary TB are assigned to either about 2 grams per day of omega-3 long-chain fatty acids (EPA and DHA) or a placebo for the 8-week intensive TB phase. The primary outcome is sputum culture time to positivity, with secondary outcomes including time to stable culture conversion, 8-week culture conversion rates, inflammatory markers, and safety. Exploratory aims cover iron status, body composition, muscle strength, metabolic and gene expression measures, and related biomarker analyses. The trial seeks to determine if adjunct omega-3s can enhance bactericidal activity, modulate inflammation, and improve clinical outcomes without added risk.

Why it matters

Who can join: the full rules

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* Pregnant or breastfeeding women or women who become pregnant in the first 4 weeks of the trial will be withdrawn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.

Where it's running

• Perinatal HIV research Unit (Matlosana)
  Klerksdorp, North West, South Africa Recruiting

Study contacts

• Principal investigator: Linda prof — North West University
• Study coordinator: Tumelo Dr
• Email: moloantoat@phru.co.za
• Phone: +27 180113800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.