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

NCT05958277 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-07-24

No results posted yet for this 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.

Conditions

Interventions

DRUG

Vitamin B3

Vitamin B3 upto 16 mg/day

DRUG

Vitamin B12

Vit B12 upto 250 mcg per day

Sponsors & Collaborators

  • KRL Hospital, Islamabad

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-01-28
Completion
2023-02-03

Countries

  • Pakistan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05958277 on ClinicalTrials.gov