RecruitingPhase 4NCT07029698

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

Efficacy and Safety of a Parenterally Administered Fixed Vitamin Combination (Vitamin B6, B12 and Folic Acid) On Vitamin B12 Status and Methylation Capacity in Cobalamin Deficiency Compared to Oral Vitamin B12 Supplementation


Sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Enrollment

46 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Vitamin B12 (Cyanocobalamin) and a drug called Vitamin B12, Vitamin B6, Folic acid for people with vitamin b12 deficiency. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVitamin B12, Vitamin B6, Folic acid

A solution for intramuscular injection of fixed vitamin combination (5 mg vitamin B6, 1 mg B12 and 1,05 mg folic acid )

DRUGVitamin B12 (Cyanocobalamin)

oral tablets of 1mg Vitamin B12


Locations(2)

State institution "V. Danilevsky Institute for Endocrine Pathology Problems of the NAMS of Ukraine"

Kharkiv, Ukraine

Private Enterprise Private Manufacturing Company "Acinus"

Kropyvnytskyi, Ukraine

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NCT07029698