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A study to compare efficacy of oral vs intramuscular vitamin B12 in resolution of tremors in children with infantile tremor syndrome

Efficacy of intramuscular Vitamin B12 versus oral vitamin B12 in children with Infantile tremor syndrome- A Pilot Randomized Clinical Trial - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071373
Enrollment
60
Registered
2024-07-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: G252- Other specified forms of tremor

Interventions

Intervention1: Intramuscular Vitamin B12: Parenteral form of Vitamin B12 (im route) for one month Intervention2: Oral Vitamin B12: oral form of vitamin B12 for one month

Sponsors

Pt BD Sharma PGIMS Rohtak Haryana India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 6 months-2 years of either gender with developmental delay/regression with Skin hyperpigmentation, Sparse/ lightly pigmented hair, and Tremors.

Exclusion criteria

Exclusion criteria: 1. Received oral/parenteral vitamin B12 within one month prior to admission. 2. Known case of hemolytic anemia/other hematological disorder. 3. Tremors due to any other known neuro pathology and on treatment. 4. Children with normal serum vitamin B12 levels. 5. Refusal of consent by parent/guardian.

Design outcomes

Primary

MeasureTime frame
clinical outcome in terms of resolution of tremors in both the groups during follow up (at 1 month).Timepoint: clinical outcome in terms of resolution of tremors in both the groups during follow up (at 1 month).

Secondary

MeasureTime frame
compliance of both modalities of therapy i.e. parenteral and oral vitamin B12.Timepoint: one month;hematological parameters in both groups at 1 month follow up.Timepoint: one month;levels of serum vitamin B12 in children with Infantile tremor syndrome before and after therapy.Timepoint: day 0 and at one month follow up

Countries

India

Contacts

Public ContactPAYAL MITTAL

Pt. B.D. Sharma, PGIMS, Rohtak

ndvaswani@hotmail.com9034428284

Outcome results

None listed

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