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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
A solution for intramuscular injection of fixed vitamin combination (5 mg vitamin B6, 1 mg B12 and 1,05 mg folic acid )
oral tablets of 1mg Vitamin B12
State institution "V. Danilevsky Institute for Endocrine Pathology Problems of the NAMS of Ukraine"
Kharkiv, Ukraine
RECRUITINGPrivate Enterprise Private Manufacturing Company "Acinus"
Kropyvnytskyi, Ukraine
RECRUITINGVitamin B12
Effects of treatment on serum vitamin B12
Time frame: Change from baseline at day 28
Holotranscobalamin
Effects of treatment on serum holotranscobalamin
Time frame: Change from baseline at day 28 and at follow up at day 56
Homocystein
Effects of treatment on serum homocystein
Time frame: Change from baseline at day 28 and at follow up at day 56
Methylmalonic acid
Effects of treatment on serum methylmalonic acid
Time frame: Change from baseline at day 28 and at follow up at day 56
Combined vitamin B12 marker (cB12)
Effects of treatment on cB12. Combined vitamin B12 markers (cB12) will be statistically calculated using the levels of Serum holotranscobalamin, Serum homocysteine, Serum methylmalonic acid. cB12 (cB12=log10\[(holoTC x B12)/(MMA x Hcy)\]-(age factor).
Time frame: Change from baseline at day 28 and at follow up at day 56
Serum S-adenosylmethione (SAM)
Effects of treatment on serum S-adenosylmethione (SAM)
Time frame: Change from baseline at day 28 and at follow up at day 56
Serum S-adenosylhomocysteine (SAH)
Effects of treatment on serum S-adenosylhomocysteine (SAH)
Time frame: Change from baseline at day 28 and at follow up at day 56
SAM/SAH ratio
The change of the ratio will be assessed statistically using the levels of Serum S-adenosylmethione (SAM) and Serum S-adenosylhomocysteine (SAH)
Time frame: Change from baseline at day 28 and at follow up at day 56
Quality of life assessed with SF-36
Effects of treatment on SF-36 questionnaire (from 0 to 100 points in each of the eight subscales, where the higher score means the higher quality of patient's life in each domain)
Time frame: Change from baseline at day 28 and at follow up at day 56
Quality of life assessed with WHO-5 questionnaire
Effects of treatment on WHO-5 questionnaire (from 0 to 25, where the higher score means the higher quality of patient's life)
Time frame: Change from baseline at day 28 and at follow up at day 56
Quality of life assessed with VAS EQ-5D
Effects of treatment on visual analogue scale EQ-5D (from 0 "the worst possible quality of life" to 10 "the best possible quality of life")
Time frame: From baseline to day 28 and at follow up at day 56
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