Oral Versus Intravenous Vitamin B12 Replacement in Hemodialysis Patients

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).

The goal of this clinical trial is to learn whether intravenous (IV) vitamin B12 works better than oral vitamin B12 to correct vitamin B12 deficiency in adults on maintenance hemodialysis.

The main questions it aims to answer are: Does IV vitamin B12 raise blood B12 levels more than oral vitamin B12 over four weeks?

Does IV vitamin B12 lead to more patients reaching a normal blood B12 level than oral vitamin B12?

It had two arms (groups): IV mecobalamin (active comparator) and Oral mecobalamin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Left uncorrected, deficiency contributes to anemia, peripheral neuropathy, cognitive impairment, and hyperhomocysteinemia, an established cardiovascular risk factor in this population.

Cobalamin has traditionally been replaced by the intramuscular route, but intramuscular injection is painful and carries a risk of hematoma and bruising in HD patients because of the prophylactic heparin used during dialysis.

This has driven a shift toward oral and intravenous (IV) supplementation.

Existing randomized and network meta-analysis evidence shows that oral, intramuscular, and sublingual routes achieve comparable biochemical correction, but this evidence comes from populations with normal or near-normal renal function and does not include the IV route.

Who Took Part

60 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients aged 18-75 years. Patients with diagnosed vitamin B12 deficiency (serum B12 levels \< 200 pg/mL as measured by ELISA ( Enzyme linked immunosorbent Assay). Patients who were on hemodialysis therapy of 4-hour duration (average 3-4 hours) thrice per week for at least the last 3 months. Willingness to provide informed and written consent for participation in the study.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: patients with age \<18 years and \>75 years; patients with diagnosed pernicious anemia; history of previous allergic reactions to vitamin b12 supplementation.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.

It started in 2026-02-22 with completion listed for 2026-05-22.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Serum Vitamin B12 Level from Baseline to Week 5 (time frame: Baseline and Week 5 (one week after completion of the 4-week intervention)).

It also tracked 6 secondary outcomes, for example Proportion of Participants Achieving Serum Vitamin B12 >200 pg/mL at Week 5, Change in Hemoglobin from Baseline to Week 5, Change in Mean Corpuscular Volume from Baseline to Week 5, Change in Mean Corpuscular Hemoglobin from Baseline to Week 5, Change in Mean Corpuscular Hemoglobin Concentration from Baseline to Week 5 and Change in hematocrit (%).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cyanocobalamin (Vitamin B12) in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.