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

Recruiting Phase 4 Interventional Study
Vitamin B12 Deficiency
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
46 (estimated)
Sponsor
Medice Arzneimittel Pütter GmbH & Co KG · Industry
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About This Trial
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 …
Trial Locations
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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 patien…
Contacts

Igor Zupanets, Prof.Dr.

+380679093809

igorzupanets@gmail.com

CONTACT

Tetyana Kolodyezna, PhD

+380937387790

kolodeznaya@aisconsulting.com.ua

CONTACT