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TuberculosisPhase 2TREAT 3NCT07118059

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

A Phase 2 study testing Omega-3 (EPA+DHA) in people with Tuberculosis and Inflammation Biomarkers, run by North-West University, South Africa at 1 site in South Africa.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years
What is being tested?
Omega-3 (EPA+DHA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSouth Africa
Study dates
19 Aug 2026to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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  • Pregnant or breastfeeding women or women who become pregnant in the first 4 weeks of the trial will be withdrawn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:
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tumelo Dr contact

+27 180113800

moloantoat@phru.co.za

Ziska Pretorius, B. Cur contact

+27 180113815

pretoriusz@phru.co.za

South Africa1 site, 1 recruiting

  • Perinatal HIV research Unit (Matlosana)

    Klerksdorp, North West, 2571

    Tumelo DR, +27 180113800, moloantoat@phru.co.za

    Ziska Pretorius, pretoriusz@phru.co.za

    Recruiting

Other trials in South Africa

About this study

Official title: Effects of Adjunct Omega-3 Long-chain Polyunsaturated Fatty Acids in Pulmonary Tuberculosis Patients: An Early Bactericidal Activity and Inflammatory Activity Trial

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:

Read more
  • 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
Read the detailed description

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.

Being tested
Omega-3 (EPA+DHA), Placebo
Keywords
Pulmonary tuberculosis, Patients, adjunct omega-3 long chain polyunsaturated fatty acid, early bactericidal, safety trial
Medical subject headings
Tuberculosis, Tuberculosis, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • PlaceboDietary 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

Study groups in NCT07118059
Study groupRoleWhat they receive
Omega 3 Long chain Polyunsaturated fatty acidExperimental20 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
Receives: Dietary Supplement: Omega-3 (EPA+DHA)
High Linoleic sunflower oilPlacebo comparatorThe 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
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. 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

    Measured: Sputum cultures to measure time to stable culture conversion will be measured on days: 1,4,7,14,21,30 and 60

  2. 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.

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

  3. 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

    Measured: baseline, day 7, day 30 and day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start19 Aug 2026
  3. Primary completionNov 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07118059
Sponsor's protocol ID
TREAT 3
Other IDs
20250308, 250209
Acronym
TREAT 3
Status last verified
Sep 2026
First submitted
4 Aug 2025
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 34504860

  • 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.

    PubMed 32847532

  • 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.

    PubMed 34082319

  • 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.

    PubMed 24437320

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Omega-3 (EPA+DHA) in people with Tuberculosis and Inflammation Biomarkers, run by North-West University, South Africa at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tumelo Dr (+27 180113800, moloantoat@phru.co.za), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sputum culture time to positive (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07118059, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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