Can an injection beat pills for vitamin B12 deficiency?
NCT ID NCT07029698
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 Hide 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.
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.