[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-function-tests\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-function-tests":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"100602019","phase-2-effects-of-adjunct-omega-3-long-chain-polyunsaturated-fatty-acids-in-pulmonary-tuberculosis-patient-an-early-bactericidal-activity-and-inflammatory-trial-100602019",false,"NCT07118059","Effects of Adjunct Omega-3 Long Chain Polyunsaturated Fatty Acids in Pulmonary Tuberculosis Patient: an Early Bactericidal Activity and Inflammatory Trial","Effects of Adjunct Omega-3 Long-chain Polyunsaturated Fatty Acids in Pulmonary Tuberculosis Patients: An Early Bactericidal Activity and Inflammatory Activity Trial","TREAT 3","Inclusion Criteria:\n\n* adults aged 18-45 years\n* laboratory confirmed Pulmonary TB defined as a hard copy of a sputum result detected by WHO recommended assay or mycobacteria culture.\n* Women of childbearing potential with a negative pregnancy test on enrollment\n* All participant irrespective of HIV status who consent to have a HIV test during enrollment.\n\nExclusion Criteria:\n\n* Comorbid condition with treatment of NSAIDS is indicated\n* Institutionalized or incarcerated individuals\n* 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initiation\n* Pregnant or breastfeeding women or women who become pregnant in the first 4 weeks of the trial will be withdrawn\n* show lab safety values: AST or ALT \\> x3 upper limit of normal (ULN) or Total bilirubin \\> 2x the ULN, Neutrophils ≤ 700\u002Fmm³, Platelets \\\u003C 50,000\u002Fmm³, Haemoglobin \\\u003C 8 g\u002FdL, Serum creatinine \\> 2× ULN.\n* Are receiving or planning treatment with any of the following in the 3 months before or during the trial:\n\nAnticoagulants Immune-modulating therapy (e.g., cancer treatment, oral\u002Finhaled corticosteroids) Antacids or proton pump inhibitors (PPIs)\n\n* Have a known allergy or sensitivity to fish or fish oil.\n* Have a recent history (within 2 years) or current clinical evidence of:\n\nPeptic ulcer disease or GI bleeding Coagulopathy or bleeding disorders Kidney or liver disease requiring hospitalisation Cardiovascular disease or significant risk factors for it\n\n-Are HIV-positive and meet any of the following: CD4 count \\\u003C 100 cells\u002Fmm³ Viral load \\> 400 copies\u002FmL (if on ART) Not yet on ART but are expected to initiate treatment during the 8-week intervention phase\n\n* Report high-risk alcohol use (average \\>4 units\u002Fday or binge drinking patterns)\n* Have any other medical condition or situation that, in the investigator's opinion, may interfere with protocol adherence or data interpretation.\n* Plan to relocate from the study area within the next 3 months.\n* Are currently using omega-3 or omega-6 supplements and are unwilling to stop for the duration of the study.","ALL","18 Years","45 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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.\n\nThe main questions it aims to answers are:\n\n* Does adjunct n-3 LCPUFA supplementation reduce the sputum culture time to positivity\n* 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.\n\nParticipants will:\n\n* Be randomly assigned to receive either n-3 LCPUFA or Placebo daily for 8 weeks with the intensive phase of TB treatment\n* 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\n* Provide blood, sputum and urine samples for biomarkers and metabolomic analysis\n* Undergo assessments of iron status, body composition and muscle strength",[28,29,30,31,32,33,34],"Tuberculosis","Inflammation Biomarkers","Liver Function Tests","Iron Status","Metabolomics","Nutritional Status","Clinical Outcomes",[36,37,38,39,40],"Pulmonary tuberculosis","Patients","adjunct omega-3 long chain polyunsaturated fatty acid","early bactericidal","safety trial","NOT_YET_RECRUITING","2025-08-04",{"date":44,"type":45},"2025-08-12","ACTUAL",{"date":47,"type":22},"2025-08",{"date":49,"type":22},"2026-12",{"name":51,"class":52},"North-West University, South Africa","OTHER"]