Can an injection beat pills for vitamin B12 deficiency?

NCT ID NCT07029698

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests whether an injected mix of vitamins B6, B12, and folic acid raises vitamin B12 levels better than standard oral B12 tablets in adults with B12 deficiency. Researchers measure blood markers of B12 status and methylation capacity after 4 weeks of treatment. They also track well-being and quality of life. The goal is to see which approach more effectively corrects the deficiency and supports key metabolic processes.

What this could mean

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

Active substance
An injected fixed combination of vitamin B6, vitamin B12, and folic acid, compared with oral vitamin B12 tablets
What this could lead to
If the injection works better, it could offer a faster or more effective way to correct vitamin B12 deficiency and improve related metabolic functions.
What could go wrong
This is a small, phase 4 trial with 46 participants, so results may not apply broadly. The injection may not prove superior to oral tablets, and injections carry risks like pain or allergic reactions.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

46 people

The number who actually took part.

Started

Apr 2025

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

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: 1. Provision of written informed consent to participate in the study (according to Order of the Ministry of Health of Ukraine No. 690 (with amendments)). 2. Female and male patients aged ≥18. 3. Vitamin B12 deficiency, defined as serum vitamin B12 \< 350 pmol/L. 4. Female patients of childbearing potential (WOCBP) must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc., with the exception of oral contraceptives), from the time of screening and for the duration of the study, through study completion and for 1 month following study completion. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Postmenopausal females must have had no regular menstrual bleeding for at least one (1) year prior to initial dosing. Female patients who report surgical sterilization must have had the procedure at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF. All female patients of childbearing potential must have negative pregnancy test results at screening. An additional pregnancy test will be performed on Days 0, 28, 56. 5. Able to communicate well with the investigator and able to understand and comply with the requirements of the study. 6. Patients are otherwise in relatively good health as determined by past medical history, physical examination, vital signs, and laboratory tests at screening (V -1). Exclusion Criteria: 1. Active or recent vitamin B12, folic acid, B6 intake (the subject must not receive vitamin B12, folic acid, B6 drugs or food supplements for at least 6 months). 2. Participation in a previous clinical study with vitamin B12 within the 6 months prior to screening. 3. Any contraindication to one of the study drugs. 4. Pregnant or nursing (lactating) women. 5. Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation. 6. Subjects with anemia (hemoglobin \< 10 mg/dL) or significant neurological symptoms due to vitamin B12 deficiency. 7. Any diseases that prevent intrinsic-factor independent passive diffusion in the small intestine (e.g. ileum resection) 8. Current drug addiction and/or alcohol abuse as evidenced by patient history and/or as determined by the investigator at V-1. 9. Cognitive or behavioural abnormalities that could impair the capacity to give informed consent or carry out protocol-specified procedures. 10. Inability to take oral medication. 11. Inability or unwillingness to comply with the study protocol. 12. Previous (last 6 months) or current participation in another clinical study. 13. Other medical, neuropsychiatric, or social conditions that, in the opinion of the investigator, are likely to adversely affect the risk-benefit of study participation, interfere with study compliance, or confound the study results. 14. Subjects who are in a dependent relationship with the Investigator or the Sponsor. 15. Subjects unwilling to give written informed consent to saving and/or propagation of anonymised medical data

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Vitamin B12 deficiency are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • Private Enterprise Private Manufacturing Company "Acinus"

    Kropyvnytskyi, 25006, Ukraine

  • State institution "V. Danilevsky Institute for Endocrine Pathology Problems of the NAMS of Ukraine"

    Kharkiv, 61002, Ukraine

More trials for these conditions

Other studies related to the condition(s) this trial covers.