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

NCT07118059 | Not Yet Recruiting Phase 2 DMC

• 3 other identifiers: TREAT 320250308250209
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tuberculosis; Inflammation Biomarkers; Liver Function Tests; Iron Status; Metabolomics; Nutritional Status; Clinical Outcomes

Keywords

Pulmonary tuberculosis; Patients; adjunct omega-3 long chain polyunsaturated fatty acid; early bactericidal; safety trial

Outcome Measures

Primary Outcomes (1)

• 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

  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

Secondary Outcomes (3)

• time to stable culture conversion

  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

  sputum cultures will be collected at day 1, day 4, day 7, day 14, day 21, day 30 and day 60

• Safety measures

  baseline, day 7, day 30 and day 60

Study Arms (2)

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

Dietary Supplement: Omega-3 (EPA+DHA)

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

Dietary Supplement: Placebo

Interventions

Omega-3 (EPA+DHA) DIETARY_SUPPLEMENT

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

Omega 3 Long chain Polyunsaturated fatty acid

Placebo DIETARY_SUPPLEMENT

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

High Linoleic sunflower oil

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• North-West University, South Africa: lead
• Perinatal HIV Research Unit of the University of the Witswatersrand: collaborator

Study Sites (1)

Perinatal HIV research Unit (Matlosana)

Klerksdorp, North West, 2571, South Africa

Location

Related Publications (4)

• Hayford FEA, Dolman RC, Ozturk M, Nienaber A, Ricci C, Loots DT, Brombacher F, Blaauw R, Smuts CM, Parihar SP, Malan L. Adjunct n-3 Long-Chain Polyunsaturated Fatty Acid Treatment in Tuberculosis Reduces Inflammation and Improves Anemia of Infection More in C3HeB/FeJ Mice With Low n-3 Fatty Acid Status Than Sufficient n-3 Fatty Acid Status. Front Nutr. 2021 Aug 24;8:695452. doi: 10.3389/fnut.2021.695452. eCollection 2021.

  PMID: 34504860 BACKGROUND

• Hayford FEA, Dolman RC, Blaauw R, Nienaber A, Smuts CM, Malan L, Ricci C. The effects of anti-inflammatory agents as host-directed adjunct treatment of tuberculosis in humans: a systematic review and meta-analysis. Respir Res. 2020 Aug 26;21(1):223. doi: 10.1186/s12931-020-01488-9.

  PMID: 32847532 BACKGROUND

• Nienaber A, Ozturk M, Dolman RC, Zandberg L, Hayford FE, Brombacher F, Blaauw R, Smuts CM, Parihar SP, Malan L. Beneficial effect of long-chain n-3 polyunsaturated fatty acid supplementation on tuberculosis in mice. Prostaglandins Leukot Essent Fatty Acids. 2021 Jul;170:102304. doi: 10.1016/j.plefa.2021.102304. Epub 2021 May 26.

  PMID: 34082319 BACKGROUND

• Nenni V, Nataprawira HM, Yuniati T. Role of combined zinc, vitamin A, and fish oil supplementation in childhood tuberculosis. Southeast Asian J Trop Med Public Health. 2013 Sep;44(5):854-61.

  PMID: 24437320 BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Linda prof

  North West University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tumelo Dr

CONTACT

+27 180113800; moloantoat@phru.co.za

Ziska Pretorius, B. Cur

CONTACT

+27 180113815; pretoriusz@phru.co.za

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: This is double blinded placebo controlled early bactericidal activity and early inflammatory activity phase two clinical trial. Participants will be randomly assigned to either receive standard of care as per South African National TB guidelines (2014) plus n-3 LCPUFA in the treatment arm or standards of care plus placebo (high linoleic sunflower oil ). The study will be a single trial study done at the Perinatal HIV research Unit in Matlosana

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 12, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• 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

Locations

ZA (1)