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Oral versus IV vitamin B12 vitamin B12 deficiency

Comparison between oral versus intravenous vitamin B12 supplementation in vitamin B12 deficient patients - COURAGE-12

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/026225
Enrollment
60
Registered
2020-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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 Vitamin B12: Arm A: Oral vitamin B12 1500 microgram orally once a day for 4 weeks Control Intervention1: Intravenous Vitamin B12: Arm B: Vitamin B12 1000 microgram IV weekly fo

Sponsors

CMC Ludhiana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Anemia as per WHO definition 2. Above 18 years of age 3. Low vitamin B12 level (below 250 pg/ml) 4. With or without symptoms or signs of vitamin B12 deficiency (except severe neurological symptoms)

Exclusion criteria

Exclusion criteria: Refusal to consent for the study 2. Hemoglobin level below 5 g/dl or Platelet count below 20000/mm3 3. Patients with ongoing oral vitamin B12 supplement 4. Documented pernicious anemia or malabsorption disorders 5. Serious neurological or psychiatric symptoms 6. Surgery or diseases affecting the jejunum-ileum 7. Hypersensitivity to vitamin B12 or any vitamin preparations 8. Pregnant females with vitamin B12 deficiency 9. Serum Folic acid less than 2.3 ng/ml 10. Stage IV Kidney disease 11. Already involved in any other ongoing trial

Design outcomes

Primary

MeasureTime frame
To check vitamin B12 level at 5th week post initiation of treatment.Timepoint: To check vitamin B12 level at 5th week post initiation of treatment.

Secondary

MeasureTime frame
1. Haemoglobin level, MCV, reticulocyte count 2. To analyse the cost difference 3. Improvement in signs and symptoms present at the time of diagnosis. Timepoint: 5 weeks

Countries

India

Contacts

Public ContactKetan Modak

CMC Ludhiana

ketan.modak@cmcludhiana.in9967109962

Outcome results

None listed

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