Comparing the Effectiveness of oral Vitamin B12 and Injectable for Treating Children with neurocutaneous infantile B12 deficiency syndrome

Comparing the efficacy of oral versus injectable vitamin B12 in patients with Neurocutaneous Infantile Vitamin B12 deficiency Syndrome (NIBS): A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088909

Enrollment

100

Registered

2025-06-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: E538- Deficiency of other specified B group vitamins

Interventions

Intervention1: Oral vitamin B12: 500 mcg of oral vitamin B12 given for 2 months Control Intervention1: Parentral(IM) vitamin B12: 500 mcg of IM vitamin B12 alternate days for 1 week than give weekly f

Eligibility

Inclusion criteria

Inclusion criteria: All infants fulfilling criteria for NIBS with low vitamin B12 levels which is-: Developmental delay/Regression of milestones. or Skin pigmentation or Brown scanty scalp hair or Tremors

Exclusion criteria

Exclusion criteria: Known case of neurodevelopmental delay with GDD or tremors. Other causes of anemia e.g. Thalassemia, Sickle cell anemia etc

Design outcomes

Primary

Measure	Time frame
To assess the effectiveness in terms of neurological outcome. To assess the effectiveness in terms of haematological outcome.Timepoint: 1 week	—

Secondary

Measure	Time frame
To evaluate the safety profile and adverse effect associated with both oral and IM routes of administration of vitamin B12 supplementation. To provide evidence-based recommendations for clinicians regarding the optimal route of administration for vitamin B12 supplementation in patients of NIBS.Timepoint: 2 months	—

Countries

India

Contacts

Public ContactDr Deepak dwivedi

Shyam shah medical college

deepakdwi72@gmail.com7869918636

Outcome results

None listed

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