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Comparison of oral and injectable route of vitamin B12 therapy in children with Vitamin B12 deficiency anaemia.

Efficacy of oral verses parenteral vitamin B12 therapy in children with Vitamin B12 deficiency anaemia

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051249
Enrollment
100
Registered
2023-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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: oral b12: Group B (oral therapy)will be treated with 1000 microgram oral vitamin B12 (cyanocobalamine) daily for 1 month. Control Intervention1: parenteral vitamin b12: After randomizat

Sponsors

Government medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Children of age group - 6 months to 18 years 2) Anemia as defined by WHO. 6-59 months â?? less than 110 g/l at sea level 5-11 yearsâ?? less than 115 g/l at sea level 12-14 yearsâ?? less than 120 g/l at sea level More than 15 yearsâ?? less than 130 g/l at sea level25 Corrected haemoglobin concentration according to sea level correction factor for altitude. 3) Serum vitamin B12 levels below 350 pg/ml OR Holotranscobalamin levels below 35 pmol/l 22,26 will be included in

Exclusion criteria

Exclusion criteria: 1. Children who have already received Vitamin B12. 2. Children who are already taking micronutrient supplementation. 3. Children with iron deficiency anemia (Iron deficiency will be defined by serum ferritin 4. Children who have received blood transfusion within last 1month.12 5. Any critical illness with hemodynamic compromise or on life support measures.

Design outcomes

Primary

MeasureTime frame
1. Biochemical parameters- a) Difference in serum vitamin B12 levels after one week and one month of therapy from baseline levels in both oral and intramuscular groups. b) Difference in holotranscobalamin levels after one week and one month of therapy from baseline levels in both oral and intramuscular groups. c) Difference in serum homocysteine levels after one week and one month of therapy from baseline levels in both oral and intramuscular groups 2. Haematological parameters- These will be reassessed as done at enrollment after one week and one month of therapy from baseline levels in both oral and intramuscular groups. Differences from baseline in all these parameters will be assessed at 1 week and 1 month of therapy. 3. Clinical parameters-Clinical improvement in the form of subjective improvement in weakness, fatigue , anorexia, failure to thrive, pallor and irritability after 1 month of therapy with vitamin B12 in both oral and intramuscular groups .Timepoint: For biochemical and haematological parameters- Day 1, 1 week, 1 month clinical -day 1 and 1 month

Secondary

MeasureTime frame
clinical improvement in the form of subjective improvement in weakness, fatigue , anorexia. failure to thrive and irritabilityTimepoint: day 1 and after 1 month of the therapy

Countries

India

Contacts

Public ContactGeetanjali Jindal

Government Medical College and Hospital, Sector 32, Chandigarh

geetanjali_jindal@yahoo.com9646121595

Outcome results

None listed

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