A clinical trial to study the effect of two different routes (nasal and parenteral) of administration of a drugs, vitamin B12, in patients with macrocytic anemia

Efficacy and safety of nasal vitamin B12 supplementation in macrocytic anemia: A randomized clinical trial - ENVMA

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/058162

Enrollment

Registered

2023-09-29

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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: nasal vitamin B12: Nasal Vitamin B12 @ 500mcg/ day x 14 days f/b 250mcg/ week from week 3-5 Control Intervention1: parenteral Vitamin B12: Vitamin B12 1000 mcg IM/IV daily x 7days f/b

Eligibility

Inclusion criteria

Inclusion criteria: 1. Hemoglobin 2. Mean corpuscular volume >100 fL. 3. Normal Transferrin saturation. 4. Should not have any comorbidities causing anemia.

Exclusion criteria

Exclusion criteria: Patients with macrocytic anemia having any of the following characteristics will be excluded 1. Patients receiving other modalities of treatment and/or alternative medicine. 2. Patients who did not consent for the study. 3. Rhinitis.

Design outcomes

Primary

Measure	Time frame
To estimate and compare the changes in the hemoglobin after nasal Vitamin B12Timepoint: 06 weeks	—

Secondary

Measure	Time frame
(i) To estimate and compare the changes in the hemoglobin after nasal Vitamin B12 at two weeks and four weeks (ii) To estimate and compare Reticulocyte response at 2 weeks and 4 weeks of therapy (iii) Time required to achieve response (iV) Safety profile Timepoint: 02 week, 04 week, 06 week	—

Countries

India

Contacts

Public ContactSarvesh Kumar

Command Hospital (Central Command), Lucknow

mishrak20@gmail.com9871323179

Outcome results

None listed

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