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
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.
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Pregnant or breastfeeding women or women who become pregnant in the first 4 weeks of the trial will be withdrawn
Parallel
Omega-3 (EPA+DHA)
Dietary supplementIn this study omega-3 will be the real thing mega omega supreme capsule, it will be used as an adjunct therapy with TB treatment in the intensive phase of treatment. Participant will receive x3, 1g capsules which will provide approximately 2g of EPA and DHA
Placebo
Dietary supplementThis group will receive the placebo, which will be 3 x 1g capsules of high linoleic sunflower oil, the sunflower capsules have been encapsulated to match the dimension of the omega 3 supplement. The capsules will also be given as and adjunct to TB treatment of the intensive phase of TB treatment
Sputum culture time to positive
which is defined as the number of hours between sample inoculation and the detection of microbial growth , A shorter detection time shows that intervention is not working and there is still a higher bacterial load in sputum whilst longer detection time shows improvement in treatment and thus effective intervention
time to stable culture conversion
time to stable culture conversion refers to the number of days from the start of TB treatment until a person has two negative sputum cultures with no subsequent positive cultures
Proportion of participants with stable sputum culture conversion
Proportion of participants with stable sputum culture conversion, is the number of participant in the group that have two or more negative culture for TB at 8 weeks, if the proportion is more in the omega-3 group compared to placebo than we can conclude that the omega 3 is an effective adjunct therapy.
Safety measures
safety outcomes including the incidence of serious adverse events and abnormal laboratory safety test including; aspartate, aminotransferase, alanine aminotransferase; 3 x the upper limit of normal. Total bilirubin 2x ULN, neutrophil count less than or equal to 700 neutrophils per mm cubed, platelet count less than fifty thousand cells per mm cubed and haemoglobin less than 8g per deciliter and lastly a serum creatinine concentration 2x the upper limit of normal
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North-West University, South Africa
Lead sponsor
Perinatal HIV Research Unit of the University of the Witswatersrand
Collaborator
