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Does High-dose Vitamin B3 Supplementation Prevent Major Adverse Kidney Events During Septic Shock?

Study acronym: VITAKI
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 24, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Jul 2025 to Sep 2025v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v6
  3. Primary completion date: Oct 2023 to Jul 2025
    • Study completion date: Jan 2024 to Jul 2025
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2020 to Oct 1, 2020
    • Site details revised
    v3
  6. Site contact updatedv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sepsis is the most common cause of acute kidney injury (AKI) in critically ill patients and is associated with a high mortality rate. Currently there is no available specific treatment to prevent or treat AKI in this setting. Many experimental and clinical data suggest that Nicotinamide, a safe and inexpensive vitamin, could be effective to prevent major adverse kidney events during septic shock. The main objective of the study is to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care. A 15% reduction in the incidence of major renal adverse events at day 30 is expected in the "Nicotinamide" group.
Trial Details
NCT Number NCT04589546
Lead Sponsor Centre Hospitalier Universitaire, Amiens
Collaborators: Centre Hospitalier de Dieppe, Centre Hospitalier d'Abbeville, Centre Hospitalier de Laon, University Hospital, Caen, Centre Hospitalier de Cherbourg, University Hospital, Rouen, Centre Hospitalier de Roubaix, Centre Hospitalier de Bethune, Hôpital Saint Philibert, Lomme, Tourcoing Hospital, Centre Hospitalier de Valenciennes, Centre Hospitalier Arras, Centre Hospitalier de Lens, Centre Hospitalier de Calais
Conditions
(from sponsor)		 Acute Kidney Injury, Septic Shock, Nicotinamide, Mortality
Related terms Acute Kidney Injury, Shock, Septic
Enrollment 310 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov