Is sublingual vitamin B12 preparations as effective as oral vitamin B12 preparations for the treatment of vitamin B12 deficiency?

Efficacy of sublingual versus oral vitamin B12 supplementation for the treatment of vitamin B12 deficiency -A randomized open label study

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039743

Enrollment

144

Registered

2022-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: E538- Deficiency of other specified B group vitamins Health Condition 2: R798- Other specified abnormal findingsof blood chemistry

Interventions

Intervention1: Sublingual Vitamin B12: Sublingual Vitamin B12 1500mcg once daly for 3 months Control Intervention1: oral Vitamin B12: oral vitamin B12 1500mcg once daily for 3 months

Eligibility

Inclusion criteria

Inclusion criteria: All patients with documented vitamin B12 deficiency(serum vitamin B12 level <240pg/ml) who consent for the study

Exclusion criteria

Exclusion criteria: 1.Age 2.Pregnancy 3.Serious neurological or psychiatric symptoms 4.Surgery or diseases affecting the ileum 5.Patient receiving vitamin b12 supplementation 6.Renal insufficiency 7.Patient who fails to give consent 8.Drugs that can cause megaloblastic anemia: (methotrexate, mesalazine, phenobarbital , valproic acid, phenytoin etc., )

Design outcomes

Primary

Measure	Time frame
Improvement in serum vitamin B12 levels (more than 400 pg/ml)Timepoint: three months after initiation of therapy	—

Secondary

Measure	Time frame
Improvement in clinical signs and symptoms of vitamin B12 deficiency and mean corpuscular volume ,Any adverse events,AcceptibilityTimepoint: three months	—

Countries

India

Contacts

Public ContactArun R S

The madras medical mission

drarunrs@gmail.com044-26568312

Outcome results

None listed

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