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

K

KRL Hospital, Islamabad

Status and phase

Completed
Phase 3

Conditions

Traumatic Brain Injury

Treatments

Drug: Vitamin B3
Drug: Vitamin B12

Study type

Interventional

Funder types

Other

Identifiers

NCT05958277
KRL/02/19/2

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

6 to 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

Vitamin B3
Experimental group
Description:
Vitamin B3 group
Treatment:
Drug: Vitamin B3
Vitamin B12 group
Experimental group
Description:
Vitamin B12 group
Treatment:
Drug: Vitamin B12

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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