Can an IV boost beat pills for B12 deficiency in kidney dialysis?

NCT ID NCT07781020

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial asks whether an intravenous (IV) injection of vitamin B12 works better than oral tablets to correct B12 deficiency in adults on long-term hemodialysis. Participants receive either a weekly IV dose after dialysis or oral tablets three times a day for four weeks. Researchers compare blood B12 levels, blood counts, and nerve symptoms like numbness and tingling at the start and after five weeks. The goal is to find the most effective way to restore B12 levels in this vulnerable group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mecobalamin (a form of vitamin B12) given either as an intravenous injection or as oral tablets
What this could lead to
If IV B12 proves more effective, it could become the preferred way to treat B12 deficiency in dialysis patients, potentially improving energy, blood counts, and nerve symptoms.
What could go wrong
This is a small, non-randomized study, so results may not apply broadly. IV treatment carries risks like injection-site reactions, and oral B12 may not absorb well in dialysis patients.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Feb 2026

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Patients with age \<18 years and \>75 years * Patients with diagnosed pernicious anemia * History of previous allergic reactions to vitamin B12 supplementation * Patients treated with hemodialysis therapy with less than 3 months duration * Patients on peritoneal dialysis * Patients on strict vegetarian diets * History of gastric or intestinal surgical procedures * Conditions affecting the small intestine, such as ileal resection, Crohn's disease, celiac disease, or malabsorption syndrome * Patients with known autoimmune diseases like Type 1 Diabetes Mellitus, Grave's disease, etc * Pregnant female * Patients who had taken metformin during the previous 3 months. * Patients having a history of non-adherence to medications. * Inability to comply with the study requirements due to cognitive impairment, psychiatric conditions, or any form of incapacitation. * Participation in other clinical trials.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Jinnah Hospital Lahore

    Lahore, Punjab Province, 54550, Pakistan

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