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Effect of L arginine, vit B6, B12 and vit D for neurological recovery in acute spinal cord injury (ASCI) subjects

Evaluation of nutritional intervention with L arginine, vit B6, B12 and vit D for neurological recovery in acute spinal cord injury (ASCI) subjects; A Randomized Control Trial (RCT)

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024016
Enrollment
45
Registered
2020-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G958- Other specified diseases of spinalcord

Interventions

Intervention1: Vidil-3 plus bolus dose of vitamin D (Cholecalciferol): Conventional as in Group 1 and in addition, 600000 IU of vitamin D3 orally in 10 divided doses (60000 IU continuously for ten day

Sponsors

Dr R N Srivastava
Lead Sponsor
Dr Wahid Ali
Collaborator
Prof Raja Roy
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 2. ASCI less than 6 weeks of injury 3. Motor complete thoracolumbar injury (AIS A, B), 4. TLISS greater than or equal to 4 requiring surgical stabilization 5. Hypovitaminosis D: 25(OH) D levels less than 30ng/ml

Exclusion criteria

Exclusion criteria: 1. Other associated injuries such as major thoracoabdominal injuries & head injuries needing intervention. 2. Neuro-psychiatric patients and patients on steroid or other immunosuppressant therapy or other comorbid conditions making subjects unfit for surgery 3. Subjects who do not give consent for participating in the study.

Design outcomes

Primary

MeasureTime frame
Clinical Assessment- Neurological status- at baseline, at 3rd week 3rd and 6 months Nutrition status- at baseline at 3rd week 3rd and 6 monthsTimepoint: At baseline at 3rd week 3rd and 6 months

Secondary

MeasureTime frame
Quality of life (QoL) Assessment: Spinal Cord Independence Measure (SCIM) questionnaire will be used; At baseline, 3rd week, 3rd and 6 months. Metabolites status: Glycine and succinate profiling of serum bio-fluid in acute spinal cord injury in order to elucidate their possible role as prognostic indicator of neurological recovery.Timepoint: At baseline, at 3rd week, 3rd and 6 months.

Countries

India

Contacts

Public ContactAlka Singh

Dept. of Orthopaedic Surgery King Georgeâ??s Medical University

drrnsrivastava@yahoo.com9415054330

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026