A Phase 2 interventional study of Omega-3 (EPA+DHA) and Placebo in Tuberculosis, Inflammation Biomarkers and Liver Function Tests, sponsored by North-West University, South Africa. Recruiting at 1 site in South Africa. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by North-West University, South Africa · Phase 2, Interventional, and Treatment
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:
Participants will:
Anti-inflammatory omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation results in improvement of infectious respiratory conditions, yet little evidence in patients with pulmonary tuberculosis (TB) exists. Animal studies have shown that adjunct n-3 LCPUFA optimized treatment outcomes by resolving inflammation, improving immune response, and mitigating iron deficiency and anaemia of inflammation.
This randomized controlled early bactericidal activity (EBA), early inflammatory activity (EIA), and safety trial among patients with newly bacteriologically confirmed adult drug-sensitive pulmonary TB patients (DS-TB), aged 18 - 45 years (n = 40), will investigate the clinical and anti-inflammatory effects of n-3 LCPUFA adjunct treatment for two months.
Patients presenting at Tshepong Hospital, Klerksdorp, North West Province, will receive either \~2 g n-3 LCPUFA (eicosapentaenoic acid (EPA) plus docosahexaenoic acid (DHA)) or placebo (high-linoleic sunflower oil) daily for two months. The primary outcome is sputum culture time to positivity. Secondary outcomes include time to stable culture conversion, proportion of participants converted at 8 weeks, inflammatory markers and safety. Exploratory objectives include iron status, body composition and muscle strength, clinical outcomes, microbial translocation biomarkers, resting energy expenditure, fatty acid composition, plasma lipid mediators, and related metabolomics and gene expression.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's planned enrollment of 40 is below the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →North-West University, South Africa is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Compared within Tuberculosis, Pulmonary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tuberculosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Anticoagulants Immune-modulating therapy (e.g., cancer treatment, oral/inhaled ) Antacids or proton pump inhibitors (PPIs)
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 -positive and meet any of the following: \< 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 Participant will be in this arm, randomized for sex and HIV status. Participant in the intervention group will receive 3- 1g fish oil capsules capsules to take with their TB treatment of Omega 3 (real thing mega omega supreme). These capsules provide approximately 2g of EPA and DHA
Dietary Supplement: Omega-3 (EPA+DHA)
The placebo group will also consist of 20 participant randomized and stratified for sex, HIV status. They will also receive 3 1g capsules of high linoleic sunflower oil that has been encapsulated using the specification and dimension of the omega 3 real thing capsules to closely match the intervention
Dietary Supplement: Placebo
Drug page: Omega-3 fatty acid
In 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
This 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 frame: TTP will be measured on the following days of the intervention: day 1, day 4, day 7, day 14, day 21, day 30 and day 60
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
Time frame: Sputum cultures to measure time to stable culture conversion will be measured on days: 1,4,7,14,21,30 and 60
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.
Time frame: sputum cultures will be collected at day 1, day 4, day 7, day 14, day 21, day 30 and day 60
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
Time frame: baseline, day 7, day 30 and day 60
Plan to share: Yes
Time frame: beginning one year and ending 3 years after publication date
Access criteria: research who has a methodological sound proposal that has been approved by an independent review committee identified for this purpose
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Studies of the drug tested here: Omega-3 fatty acid
North-West University, South Africa