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

NCT05958277 | Completed Phase 3 DMC

• 1 other identifier: KRL/02/19/2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vitamin B3

EXPERIMENTAL

Vitamin B3 group

Drug: Vitamin B3

Vitamin B12 group

EXPERIMENTAL

Vitamin B12 group

Drug: Vitamin B12

Interventions

Vitamin B3 DRUG

Vitamin B3 upto 16 mg/day

Vitamin B3

Vitamin B12 DRUG

Vit B12 upto 250 mcg per day

Vitamin B12 group

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• KRL Hospital, Islamabad: lead

Study Sites (1)

KRL Hospital

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Niacinamide; Vitamin B 12

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 24, 2023
• Study Start: June 1, 2021
• Primary Completion: January 28, 2023
• Study Completion: February 3, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

PA (1)