[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602019":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":71,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":103,"overallStatus":109,"whyStopped":26,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"North-West University, South Africa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Omega 3 Long chain Polyunsaturated fatty acid","EXPERIMENTAL","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",[13],"Dietary Supplement: Omega-3 (EPA+DHA)",{"label":15,"type":16,"description":17,"interventionNames":18},"High Linoleic sunflower oil","PLACEBO_COMPARATOR","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",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Omega-3 (EPA+DHA)","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",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","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",[15],[32],{"name":33,"affiliation":34,"role":35},"Linda prof","North West University","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Tumelo Dr","CONTACT","+27 180113800","moloantoat@phru.co.za",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Ziska Pretorius, B. Cur","+27 180113815","pretoriusz@phru.co.za",[47],{"facility":48,"status":26,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Perinatal HIV research Unit (Matlosana)","Klerksdorp","North West","2571","South Africa","ZA",{"type":55,"coordinates":56},"Point",[57,58],26.66672,-26.85213,{"lat":58,"lon":57},[61,63,65,66,69],{"name":62,"role":39,"phone":40,"phoneExt":26,"email":41},"Tumelo DR",{"name":64,"role":39,"phone":26,"phoneExt":26,"email":45},"Ziska Pretorius",{"name":38,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":67,"role":68,"phone":26,"phoneExt":26,"email":26},"Ebrahim Prof","SUB_INVESTIGATOR",{"name":70,"role":68,"phone":26,"phoneExt":26,"email":26},"Ziska Pretorius, B.Cur",{"type":35,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Linda Malan","Prof",[75],{"name":76,"class":6},"Perinatal HIV Research Unit of the University of the Witswatersrand","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":89,"type":90},40,"ESTIMATED","INTERVENTIONAL",[93],"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",[96,97,98,99,100,101,102],"Tuberculosis","Inflammation Biomarkers","Liver Function Tests","Iron Status","Metabolomics","Nutritional Status","Clinical Outcomes",[104,105,106,107,108],"Pulmonary tuberculosis","Patients","adjunct omega-3 long chain polyunsaturated fatty acid","early bactericidal","safety trial","NOT_YET_RECRUITING","2025-08-04",{"date":112,"type":113},"2025-08-12","ACTUAL",{"date":115,"type":90},"2025-08",{"date":117,"type":90},"2026-12",{"name":5,"class":6},1]