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

Launched by NORTH-WEST UNIVERSITY, SOUTH AFRICA · Aug 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether adding omega-3 fatty acids—healthy fats found in fish oil—to the usual treatment for adults with newly diagnosed pulmonary tuberculosis (TB) can help fight the infection faster, reduce inflammation, and improve overall treatment results. Researchers want to see if taking about 2 grams of omega-3 daily, alongside standard TB medicine, can make a difference compared to a placebo (a harmless oil without omega-3). The study will also look at how this supplement affects things like liver function, iron levels, and the body’s response to infection.

Adults between 18 and 45 years old with confirmed drug-sensitive pulmonary TB may be eligible to join. Women who can become pregnant must have a negative pregnancy test before starting. People with certain health conditions, allergies to fish oil, or who are pregnant or breastfeeding won’t qualify. Participants will be randomly assigned to take either the omega-3 supplement or placebo every day for 8 weeks during the most intensive phase of TB treatment. They will visit the clinic regularly for check-ups and provide blood, sputum (spit), and urine samples to monitor their progress. The study will also measure their body strength and nutrition. This research aims to find out if omega-3 supplements can safely support TB treatment and improve recovery.

Gender

ALL

Eligibility criteria

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• • Pregnant or breastfeeding women or women who become pregnant in the first 4 weeks of the trial will be withdrawn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