Clinical trial NCT05958277: Vitamin B12 vs B3 for Nerve Regeneration and Functional Recovery After Pediatric Traumatic Brain Injury
Official title: Vitamin B12 vs B3 for Nerve Regeneration and Functional Recovery After Pediatric Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Traumatic Brain Injury
Lead sponsor: KRL Hospital, Islamabad
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Stair Climb Test (SCT) score
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: KRL Hospital
Study officials:
References: