● 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

Condition: Vitamin B12 Deficiency · Sponsor: Medice Arzneimittel Pütter GmbH & Co KG

PhasePhase 4

Planned participants46

Who can joinAll sexes, 18 Years to no upper limit

Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Igor Zupanets, Prof.Dr. · +380679093809 · igorzupanets@gmail.com

Tetyana Kolodyezna, PhD · +380937387790 · kolodeznaya@aisconsulting.com.ua

Always discuss trial participation with your own doctor first.

Locations (2)

State institution "V. Danilevsky Institute for Endocrine Pathology Problems of the NAMS of Ukraine"	Kharkiv, Ukraine	Recruiting
Private Enterprise Private Manufacturing Company "Acinus"	Kropyvnytskyi, Ukraine	Recruiting

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Source record: clinicaltrials.gov/study/NCT07029698