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Could a daily vitamin fix B12 deficiency in diabetes patients?

NCT ID NCT06983223

Disease control Sponsor: Liaquat University of Medical & Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a special oral vitamin B12 supplement (Sucrosomial® B12) can raise B12 levels in people with type 2 diabetes who have low B12 due to taking metformin. Fifty adults took either the supplement or a placebo daily for 3 weeks. The goal was to see if the supplement could correct the deficiency and improve related blood markers.

What this could mean

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

Active substance
Sucrosomial® Vitamin B12 (an oral vitamin B12 supplement)
What this could lead to
If it works, this could offer a simple, daily supplement to manage B12 deficiency in people with type 2 diabetes who take metformin.
What could go wrong
This is a small, short-term study (50 people, 4 weeks). Results may not apply to everyone, and the supplement may not work better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

50 people

The number who actually took part.

Started

Aug 2025

Finished

Dec 2025

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: * Adults aged 18 to 75 years. * Diagnosed with Type 2 Diabetes Mellitus (T2DM). * Currently on Metformin therapy for at least one year. * Serum vitamin B12 levels below the laboratory reference range (indicating deficiency). * Willing to provide written informed consent. * Able to comply with study procedures and visit schedule. Exclusion Criteria: * Current or prior use of vitamin B12 supplements within the past 3 months. * Diagnosis of pernicious anemia or other causes of vitamin B12 malabsorption (e.g., Crohn's disease, celiac disease). * History of gastric surgery or small intestine resection. * Use of medications known to interfere with vitamin B12 absorption (other than Metformin). * Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or end-stage renal disease. * Severe hepatic impairment (ALT/AST \> 3 times the upper limit of normal). * Pregnant or breastfeeding women. * Known hypersensitivity to vitamin B12 or any component of the study product. * Participation in another clinical trial within the last 30 days.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus vitamin B12 deficiency

As listed by the trial registrant

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

Type 2 diabetes mellitus (T2DM) Vitamin B 12 deficiency

Contacts and locations

Locations

  • Liaquat University of Medical & Health Sciences (LUMHS)

    Jāmshoro, Sindh, 76090, Pakistan

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