NCT05958277

Vitamin B12 vs B3 for Nerve Regeneration and Functional Recovery After Pediatric Traumatic Brain Injury

Completed Phase 3 Last updated 24 July 2023

What this trial tests

Phase 3 trial testing Vitamin B3 in Traumatic Brain Injury in 300 participants. Completed in 3 February 2023.

Timeline

1 June 2021

Primary endpoint
28 January 2023

3 February 2023

Quick facts

Lead sponsor	KRL Hospital, Islamabad
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	1 June 2021
Primary completion	28 January 2023
Estimated completion	3 February 2023
Sites	1 location across Pakistan

Drugs / interventions tested

• Vitamin B3 — full drug profile →
• Vitamin B12 — full drug profile →

Conditions studied

• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →

Sponsor

KRL Hospital, Islamabad

Who can join

Adults 6 to 15, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A traumatic brain injury (TBI) is among the most frequent reasons for neurological impairment in young people. The investigators investigated whether vitamin B12 vs B3 therapy could reduce the severity of traumatic brain injury (TBI) due to their positive effects on axon regrowth following nerve damage. The method utilized was a series of non-random samples. With a 95% confidence interval and a 5% margin of error, a total sample of 300 patients was estimated using Epi Info. Participants in our study comprised both boys and girls with severe TBI ages 6 to 15 years old.

Two groups of 300 children were recruited. B3 (16 mg/day) was administered to group 1 and B12 (125-250 mcg/day) was provided to group 2. It is evaluated through follow-ups on a range of tests to evaluate cognitive capacity, sensorimotor activity and staircase test (working and reference memory). Pre-and post-treatment GCS measurements were conducted. Three weeks and a year following the treatment of TBI, children underwent neurobehavioral testing. The measurement of gait analysis was done. The standard error and mean of statistically examined data were shown by paired t-test.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mitochondrial-targeted therapies in traumatic brain injury: From bench to bedside.
   Tabassum S, Wu S, Lee CH, Yang BSK, et al · · 2025 · cited 16× · PMID 39721917 · DOI 10.1016/j.neurot.2024.e00515
2. Drug-delivery strategies using biomaterials in the field of nerve regeneration.
   Xu L, Zhou C, Wang X, Fan C. · · 2026 · cited 2× · PMID 40536924 · DOI 10.4103/nrr.nrr-d-25-00027