Could vitamin B3 help beat TB? new trial launches
NCT ID NCT07517445
First seen Jun 24, 2026 · Last updated Aug 11, 2026 · Updated 6 times
Summary
This phase 2 trial tests whether adding nicotinamide (a form of vitamin B3) to a standard three-drug regimen can safely and effectively treat drug-susceptible pulmonary tuberculosis. About 165 adults with newly diagnosed TB will receive one of two doses of nicotinamide plus the standard drugs, or the standard drugs alone. The study measures how quickly the bacteria clear from sputum and monitors for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nicotinamide (vitamin B3) combined with bedaquiline, pretomanid, and linezolid
- What this could lead to
- If successful, this could lead to a shorter, more effective treatment regimen for drug-susceptible tuberculosis.
- What could go wrong
- This is an early phase 2 trial with only 165 participants, so results may not apply to everyone. The combination may cause side effects or not work better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 165 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-65 years at consent * Body weight 40-100 kg at screening * Written informed consent obtained * Newly diagnosed pulmonary TB, rifampicin- and isoniazid-sensitive * ≥1+ AFB smear OR positive Xpert semi-quantitative result * Molecular confirmation of M. tuberculosis * Chest X-ray consistent with TB (Investigator assessment) * Able to spontaneously produce sputum * Contraception requirements met * Females Of Child Bearing Potential: 2 approved contraceptive methods or abstinence * Males: contraception or abstinence through 90 days post-dose Exclusion Criteria: * Prior TB within 3 years, \>1 prior episode, or anti-TB treatment within 60 days * Extrapulmonary TB (except non-significant pleural/lymph node disease) * Clinically significant comorbidities or substance abuse impacting safety/compliance * Pregnant or breastfeeding * HIV-positive AND any of the following: * Not on ART or on ART \<3 months * CD4 \<200 cells/µL * Viral load \>200 copies/mL * AIDS-defining illness (other than pulmonary TB) * Screening lab abnormalities (protocol-defined LFTs, hematology, hepatitis B or C, HbA1c) * Clinically significant ECG abnormality * Use of prohibited concomitant medications (e.g., strong CYP3A4 modifiers, certain SSRIs)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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TASK Clinical Research Centre
Cape Town, Western Cape, 7530, South Africa
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The Aurum Institute Clinical Research Site - Pretoria
Pretoria, Gauteng, 87, South Africa
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UCT Lung Institute (Pty) Ltd (Centre for TB Research Innovation)
Cape Town, Western Cape, 7700, South Africa
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Wits RHI - Shandukani Research
Johannesburg, Gauteng, 2001, South Africa
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