BridgeMD
New treatment option for Vitamin B12 Deficiency
Official title 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
ClinicalTrials.gov ID: NCT07029698
What this study is testing
What is Vitamin B12, Vitamin B6, Folic acid?
Vitamin B12, Vitamin B6, Folic acid is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for vitamin b12 deficiency.
Also referred to as Medivitan® iM.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Primary efficacy objective: To investigate the effects of a parenterally vitamin B12 combination treatment versus an oral vitamin B12 mono therapy on the vitamin B12 status in female and male patients as determined by the change from baseline in serum vitamin B12 concentration after 4 weeks (28 days) of treatment. Secondary efficacy objectives: To evaluate the effects of a parenterally vitamin B12 combination versus an oral vitamin B12 mono therapy after 4 weeks of treatment on: Serum holotranscobalamin Serum homocysteine Serum methylmalonic acid Combined vitamin B12 markers (cB12) Serum folic acid Serum vitamin B6 Serum S-adenosylmethione (SAM) Serum S-adenosylhomocysteine (SAH) SAM/SAH ratio WHO-5 Well-Being Index Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) Visual analogue scale (VAS) EQ-5D.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of written informed consent to participate in the study (according to Order of the Ministry of Health of Ukraine No. 690 (with amendments)).
- Female and male patients aged ≥18.
- Vitamin B12 deficiency, defined as serum vitamin B12 \< 350 pmol/L.
- Female patients of childbearing potential (WOCBP) must be using two acceptable methods of contraception, (e.g., intra-uterine device plus condom...
- Able to communicate well with the investigator and able to understand and comply with the requirements of the study.
You likely can't join if
- 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...
- Participation in a previous clinical study with vitamin B12 within the 6 months prior to screening.
- Any contraindication to one of the study drugs.
- Pregnant or nursing (lactating) women.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- people with anemia (hemoglobin \< 10 mg/dL) or significant neurological symptoms due to vitamin B12 deficiency.
See the full eligibility criteria
- Provision of written informed consent to participate in the study (according to Order of the Ministry of Health of Ukraine No. 690 (with amendments)).
- Female and male patients aged ≥18.
- Vitamin B12 deficiency, defined as serum vitamin B12 \< 350 pmol/L.
- 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...
- Able to communicate well with the investigator and able to understand and comply with the requirements of the study.
- Patients are otherwise in relatively good health as determined by past medical history, physical examination, vital signs, and laboratory tests at screening (V -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).
- Participation in a previous clinical study with vitamin B12 within the 6 months prior to screening.
- Any contraindication to one of the study drugs.
- Pregnant or nursing (lactating) women.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation.
- people with anemia (hemoglobin \< 10 mg/dL) or significant neurological symptoms due to vitamin B12 deficiency.
- Any diseases that prevent intrinsic-factor independent passive diffusion in the small intestine (e.g. ileum resection)
- Current drug addiction and/or alcohol abuse as evidenced by patient history and/or as determined by the investigator at V-1.
- Cognitive or behavioural abnormalities that could impair the capacity to give informed consent or carry out protocol-specified procedures.
- Inability to take oral medication.
- Inability or unwillingness to comply with the study protocol.
- Previous (last 6 months) or current participation in another clinical study.
- 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...
- people who are in a dependent relationship with the Investigator or the Sponsor.
- people unwilling to give written informed consent to saving and/or propagation of anonymised medical data
The study team makes the final eligibility decision.
Where it's taking place
- Kharkiv, Ukraine
- Kropyvnytskyi, Ukraine
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kharkiv, Ukraine; Kropyvnytskyi, Ukraine. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.