Efficacy and Safety of Oral Nicotinamide as an Adjunctive Therapy in Patients With Sepsis

Summary

Sepsis is a severe, life-threatening condition caused by an abnormal host response to infection, which includes systemic inflammation, oxidative stress, and increasing organ dysfunction. It is frequently associated with bacterial, viral, fungal, or parasite infections, as well as non-infectious illnesses like trauma and pancreatitis. It remains a primary cause of mortality in hospitals, with rates nearing 40% in severely ill patients. pathophysiological, excessive cytokine release (e.g., TNFα, IL-6, IL-1β) and reactive oxygen/nitrogen species lead to mitochondrial injury, immunosuppression, and multiple organ failure. Sepsis diagnosis is guided byNEWS2 \& a SOFA score ≥2, hypotension, and elevated lactate, while worsening SOFA scores predict poor outcomes. Standard management focusses on early antibiotic therapy, fluid resuscitation, and vasoactive support. Standard anti-inflammatory methods using steroidal or non-steroidal medicines may show little efficacy to improve the patient's clinical outcomes. Adjunctive antioxidant therapies, including vitamins C and E, NAC, and melatonin, have demonstrated reductions in oxidative stress and organ dysfunction. Nicotinamide (NAM) (vitamin B3), a precursor of NAD+/NADP+ critical for energy metabolism and cellular repair, has emerged as a potential therapeutic candidate due to its ability to attenuate cytokine production, modulate immune responses, and mitigate oxidative damage. Usual dose of NAM (500mg-1500mg per day) is generally safe. A dose of 1000 mg was found to be safe and effective in reducing the circulating inflammatory cytokines showing a good profile as an anti-inflammatory adjunct therapy. Higher than usual NAM dose can increase the likelihood of adverse effects, such as diarrhea, increased liver enzymes (rarely occurring at doses exceeding 3 grams per day), symptoms of thrombocytopenia (including increased bruising and bleeding), and stomach upset.

Since the role of NAM as adjunct therapy in sepsis management is not yet established, further large-scale clinical studies are recommended to establish its efficacy and safety in sepsis management.

The aim of our study is to evaluate the efficacy and safety of the addition of Nicotinamide (1000mg oral tablet) as an adjunct therapy to improve the outcome of septic patients.

Conditions

• Sepsis - to Reduce Mortality in the Intensive Care Unit

Interventions

DRUG

Nicotinamide 1000 mg

Nicotinamide 1000 mg Tablet

Sponsors & Collaborators

• Egyptian Chinese University

  collaborator OTHER

• Ain Shams University

  lead OTHER

Principal Investigators

• Sarah Farid, PhD · Clinical Pharmacy department Faculty of Pharmacy AIn SHams University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2026-10-01

Completion

2027-01-01

Countries

• Egypt

Study Locations