Open prospective post-marketing study to support the status of iron metabolism by correcting the diet with the use of dietary supplements Vitaferr in women of reproductive age compared with active control in parallel group

The study included 120 women of reproductive age (18-49 years old) with mild iron deficiency anemia who met the inclusion criteria. The patients were randomized into 2 groups, which were similar in clinical and anthropometric data. The patients of the experimental group received the studied product containing 30 mg of elemental iron in the chelated form of bisglycinate in combination with vitamins C, B6, B12 and L-methylfolate (dietary supplement Vitaferr) 1 capsule 1 time a day with meals. The patients of the control group received a drug containing 100 mg of elemental iron in the form of sulfate in combination with 60 mg of vitamin C - 2 tablets per day. The total duration of therapy for all patients was 60 days. In the present study, the cumulative dose of iron in the experimental group (Vitaferr) was 1800 mg of elemental iron, in the control group 12,000 mg of elemental iron for 2 months (30 mg and 200 mg per day, respectively).

Adjusted for the baseline hemoglobin level, the proportion of patients in the study group who reached the target hemoglobin level was 88.9%, in the control group 94.3%, while there was no statistically significant intergroup difference (p=0.240). There were no statistically significant intergroup differences in hemoglobin, ferritin, and serum iron levels after 60 days in the study and control groups (p>0.05). The study found that 30 mg of iron bisglycinate significantly increased ferritin levels (from 24.1 ng/ml to 32.3 ng/ml) from day 15 (Visit 2), and by day 60 (Visit 4), the average serum ferritin level was 39.1 ng/ml, which was also statistically significantly higher than the baseline level (p<0.001).The dynamics of changes in VAS scores in the EQ-5D quality of life questionnaire in both groups did not differ statistically throughout all visits during the study, and by the last visit amounted to 8.68 points in the Vitaferra group and 6.2 points in the control group (p=0.182).

During the safety assessment, a total of 53 AES were registered, 100% of which were HP, characteristic of iron preparations and representing various dyspeptic phenomena. When assessing the incidence of AES, a statistically significant intergroup difference was found in the total number of AES, which was 16 (26.7%) in the Vitaferra group and 37 (61.7%) in the control group (p<0.001).  Thus, the study demonstrated the comparable effectiveness of iron bisglycinate at a dose of 30 mg of elemental Fe (2+) per day and iron sulfate at a dose of 200 mg of elemental Fe (2+) per day in terms of the frequency of patients reaching the target hemoglobin level, the dynamics of the increase in hemoglobin levels, serum iron, and the assessment according to the VAS EQ quality of life scale.-5D, with a lower frequency of adverse events.