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Oral vs intramuscular administration of vitamin B12 for the treatment of children with vitamin B12 deficiency

Daily oral v/s weekly intramuscular vitamin B12 supplementation for nutritional megaloblastic anemia in children aged 5-14 years: An open labelled Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056877
Enrollment
50
Registered
2023-08-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: E539- Vitamin B deficiency, unspecified

Interventions

Intervention1: Daily oral v/s weekly intramuscular vitamin B12 supplementation for nutritional megaloblastic anemia in children aged 5-14 years: Daily oral vitamin B12 500 mcg v/s weekly 1000 mcg intr

Sponsors

No sponsorship
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 5-14 years 2. Any of the clinical features with suspected megaloblastic anemia like pallor, hyperpigmentation of knuckles 3. Laboratory parameters suggestive of megaloblastic anemia with peripheral smear showing macrocytic red blood cells, hypersegmented neutrophils or thrombocytopenia or 3. Mean corpuscular volume > 90 fL or 4. Documented serum Vitamin B12 levels <100 pg/mL will be enrolled

Exclusion criteria

Exclusion criteria: 1. Children on drugs likely to cause peripheral blood megaloblastosis like Phenytoin/Valproate and chemotherapeutic drugs like Methotrexate 2. Hemodynamically unstable children 3. Children already on any form of vitamin B12 supplementation for more than 2 weeks 4. Patients with chronic gastrointestinal disorders/ malabsorption like coeliac disease, inflammatory bowel disease, short bowel syndrome or surgical causes. 5. Patient/caregivers not giving consent

Design outcomes

Primary

MeasureTime frame
Success in improvemnet of serum vitamin B12 levels, haemoglobin & mean corpuscular volume over 3 months periodTimepoint: 3 months

Secondary

MeasureTime frame
acceptance & safety of oral v/s intramuscular vitamin B12 supplementation among children with nutritional megaloblastic anemiaTimepoint: 3 months

Countries

India

Contacts

Public ContactP N Liveinai

Pt.B.D.Sharma PGIMS Rohtak

alkadv9@gmail.com8607407313

Outcome results

None listed

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