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

NCT07655791 | Not Yet Recruiting Phase 4

• 1 other identifier: FMASU MS 17 /2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sepsis; IL-6; NF-kB; anti-inflammatory; Nicotinamide; Mortality

Outcome Measures

Primary Outcomes (1)

• The Change in SOFA Score

  The SOFA (Sequential Organ Failure Assessment) score is a crucial ICU tool that quantifies organ dysfunction with score totaling 0-24, the higher score the worser Outcome

  7 days of receiving treatment.

Secondary Outcomes (6)

• Change in IL-6 levels in serum

  At the 7th day of follow up

• Change in NF-kB in serum

  At 7th day of follow up

• Length of ICU stay (days)

  From ICU admission until ICU discharge or death, up to 28 days

• 28 day Mortality

  At the 28th day of follow up

• Length of hospital stay (days)

  From hospital admission until discharge, up to 28 days

Study Arms (2)

Control Group

NO INTERVENTION

30 Patients will receive the treatment alone according to the hospital management protocol

Interventional Group

ACTIVE COMPARATOR

30 Patients will receive 1000mg oral Nicotinamide tablets as an adjunct therapy to the treatment provided to the sepsis patients according to the hospital management protocol.

Drug: Nicotinamide 1000 mg

Interventions

Nicotinamide 1000 mg DRUG

Nicotinamide 1000 mg Tablet

Also known as: Nicotinamide 1000 mg (Niacinamide)

Interventional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years of any gender who were admitted to the intensive care unit
• Diagnosed as sepsis patient with the Sequential Organ Failure Assessment (SOFA) Score described as an Increase in SOFA score ≥2 points due to infection.

You may not qualify if:

• Pregnant or lactating women
• Patients who had already been taking antioxidant supplements before recruiting.
• Patient with contraindications or reported allergies to Nicotinamide.

Sponsors & Collaborators

• Ain Shams University: lead
• Egyptian Chinese University: collaborator

Study Sites (1)

El Demardash Hospital

Cairo, Egypt

Location

Related Publications (24)

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MeSH Terms

Conditions

Sepsis

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sarah Farid, PhD

  Clinical Pharmacy department Faculty of Pharmacy AIn SHams University

  STUDY DIRECTOR

Central Study Contacts

Basma Ahmed, Bachelor

CONTACT

02201021975571; baabdelsattar@ecu.edu.eg

Sarah Sabry, PhD

CONTACT

00201068289698; ssabry@ecu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant , Pharmacy Practice, Egyptian Chinese University

Model Details: Group I: 30 Patients will receive 1000mg oral Nicotinamide tablets as an adjunct therapy to the treatment provided to the sepsis patients according to the hospital management protocol. Group II: 30 Patients will receive the treatment alone according to the hospital management protocol. Both groups will be monitored for sepsis management by the clinical pharmacist.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)