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A study to see how Vitamin B12 nasal spray helps children with Vitamin B12 deficiency

Effectiveness Of B12 Nasal Spray For The Treatment Of Vitamin B12 Deficiency In Children - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110179
Enrollment
50
Registered
2026-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: D519- Vitamin B12 deficiency anemia, unspecified

Interventions

Intervention1: Vitamin B12 Nasal Spray: Vitamin B12 nasal spray administered in children with vitamin B12 deficiency as per standard dosing protocol.Duration of therapy will be 8 weeks. Intervention2:

Sponsors

Department of Paediatrics King Georges Medical University Lucknow
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 5years to 18years Biochemically confirmed Vitamin B12 deficiency defined as serum Vitamin B12 levels less than 200 pg per ml

Exclusion criteria

Exclusion criteria: Known hypersensitivity to cyanocobalamin or hydroxycobalamin Severe concurrent illness requiring urgent inpatient care Symptomatic anemia or pancytopenia due to B12 deficiency Neurological symptoms due to B12 deficiency

Design outcomes

Primary

MeasureTime frame
Proportion of children with Vitamin B12 deficiency, who show a response to administration of intranasal vitamin B12 nasal spray after 4 weeksTimepoint: At baseline At 4weeks—

Secondary

MeasureTime frame
Assessment of clinical symptoms at baseline and after administration of vitamin B12 nasal sprayTimepoint: At baseline At 4weeks At 8weeks;Hemoglobin and MCV improvements are checked at baseline and after administration of Vitamin B12 Nasal sprayTimepoint: At baseline At 4weeks At 8weeks;Compliance and tolerability of Vitamin B12 nasal sprayTimepoint: At 4weeks At 8weeks—

Countries

India

Contacts

Public ContactDr Parul Verma

King Georges Medical University

nishantverma@kgmcindia.edu8765806252

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026