Actively Recruiting
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
Led by Medice Arzneimittel Pütter GmbH & Co KG · Updated on 2025-06-19
46
Participants Needed
2
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Safety objectives: To evaluate the safety and tolerability of oral vitamin B12 mono therapy versus intramuscular vitamin B12 combination.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent to participate in the study.
- Be female or male aged 18 years or older.
- Have vitamin B12 deficiency with serum vitamin B12 below 350 pmol/L.
- Female participants of childbearing potential must use two reliable contraception methods (excluding oral contraceptives) from screening through 1 month after study completion.
- Postmenopausal females must have had no regular menstrual bleeding for at least one year.
- Females with surgical sterilization must have had the procedure at least six months prior.
- Female participants of childbearing potential must have negative pregnancy tests at screening and on Days 0, 28, and 56.
- Be able to communicate well with the investigator and comply with study requirements.
- Be in relatively good health based on medical history, physical exam, vital signs, and lab tests at screening.
You will not qualify if you...
- Current or recent use of vitamin B12, folic acid, or vitamin B6 supplements or medications within the last 6 months.
- Participation in a vitamin B12 clinical study within 6 months prior to screening.
- Any contraindication to the study drugs.
- Pregnant or nursing women.
- Blood donation or loss of 400 mL or more within 8 weeks prior to first dosing.
- Anemia with hemoglobin less than 10 mg/dL or significant neurological symptoms from vitamin B12 deficiency.
- Diseases preventing vitamin B12 absorption in the small intestine (e.g., ileum resection).
- Current drug addiction or alcohol abuse.
- Cognitive or behavioral conditions impairing consent or protocol compliance.
- Inability to take oral medication.
- Unwillingness or inability to follow the study protocol.
- Participation in another clinical study within the last 6 months.
- Other medical, neuropsychiatric, or social conditions that could affect study participation or compliance.
- Being in a dependent relationship with the Investigator or Sponsor.
- Unwillingness to provide written consent for anonymized medical data storage and use.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
State institution "V. Danilevsky Institute for Endocrine Pathology Problems of the NAMS of Ukraine"
Kharkiv, Ukraine, 61002
Actively Recruiting
2
Private Enterprise Private Manufacturing Company "Acinus"
Kropyvnytskyi, Ukraine, 25006
Actively Recruiting
Research Team
I
Igor Zupanets, Prof.Dr.
CONTACT
T
Tetyana Kolodyezna, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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