A Study to See if a Combination of Vitamins That is Injected Into a Muscle is as Good and Safe as a Vitamin That is Taken by Mouth

Launched by MEDICE ARZNEIMITTEL PÜTTER GMBH & CO KG · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a combination of vitamins given as a muscle injection works as well and is as safe as taking vitamin B12 by mouth for people who have a vitamin B12 deficiency. Vitamin B12 is important for keeping your nerves and blood healthy, and this study wants to see if the injected vitamins improve vitamin B12 levels and overall well-being just as effectively as the oral vitamin. The researchers will compare how the two treatments affect blood levels of vitamin B12 and other related markers after 4 weeks, and they will also check how safe and tolerable each treatment is.

Adults aged 18 and older who have low vitamin B12 levels (below a certain amount in their blood) may be eligible to join. Women who can have children need to use two reliable forms of birth control during the study and for a month afterward. Participants should be generally healthy but not currently taking vitamin B12 or related supplements, and they cannot have serious anemia or certain medical conditions. During the study, participants will receive either the vitamin injection or oral vitamin B12 and will have their blood tested and complete surveys about how they feel. The study is currently recruiting, and anyone interested should be able to communicate well and follow the study requirements. This trial aims to find out if the injected vitamin combination is a good alternative to oral vitamin B12 for treating deficiency.

Gender

ALL

Eligibility criteria

• 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