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

Last updated: July 14, 2023
Sponsor: KRL Hospital, Islamabad
Overall Status: Completed

Phase

3

Condition

Traumatic Brain Injury

Memory Loss

Neurologic Disorders

Treatment

Vitamin B12

Vitamin B3

Clinical Study ID

NCT05958277
KRL/02/19/2
  • Ages 6-15
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children aged 6 to 15 years old
  • Children with severe TBI of
  • Children of both genders

Exclusion

Exclusion Criteria:

  • Those with mild injury
  • Stable Glasgow Coma Scale
  • Not willing to consent

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Vitamin B12
Phase: 3
Study Start date:
June 01, 2021
Estimated Completion Date:
February 03, 2023

Study 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.

Connect with a study center

  • KRL Hospital

    Islamabad,
    Pakistan

    Site Not Available

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