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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Drug: Vitamin B3; Drug: Vitamin B12

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad, Pakistan
    • KRL Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin B3; Vitamin B3 group	Drug: Vitamin B3; Vitamin B3 upto 16 mg/day
Experimental: Vitamin B12 group	Drug: Vitamin B12; Vit B12 upto 250 mcg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stair Climb Test (SCT) score	The stair test is a measurement of functional strength, balance, and agility achieved by ascending and descending a specific number of steps. Scoring involves recording the total time taken to ascend and descend the steps to the nearest 100th of a second. Lower values indicate better performance.	18 months

Collaborators and Investigators

• Sponsor: KRL Hospital, Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): January 28, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B 12; Vitamin B Complex; Niacinamide
• Other Study ID Numbers: KRL/02/19/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No