Nutritional correction of iron metabolism in women of reproductive age: results of an open-label, prospective, postregistration study with active parallel-group control

BACKGROUND: Iron deficiency anemia is one of the most common conditions worldwide and ranks first in prevalence among women of reproductive age. Conventional iron formulations are frequently associated with a high incidence of adverse effects. Therefore, there is a need to identify novel iron compounds that offer improved tolerability without compromising efficacy. AIM: To compare the outcomes of dietary correction in nonpregnant women receiving iron bisglycinate vs those receiving iron sulfate. MATERIALS AND METHODS: The study included 120 women of reproductive age (18–49 years) with mild iron deficiency anemia who met the inclusion criteria. Patients were randomized into 2 groups. The main group received the investigational product containing 30 mg of elemental iron in chelated bisglycinate form combined with vitamins C, B6, B12, and L-methylfolate (the dietary supplement VitaFerr), administered as 1 capsule once a day with food. The control group received a preparation containing 100 mg of elemental iron as sulfate combined with 60 mg of vitamin C, taken as 2 tablets per day. The total duration of therapy was 60 days. RESULTS: After adjustment for baseline hemoglobin levels, the proportion of female patients who achieved the target hemoglobin level was 88.9% in the main group and 94.3% in the control group (p=0.240). No statistically significant between-group differences were observed in hemoglobin, ferritin, or serum iron levels after 60 days (p 0.05), indicating comparable efficacy of the treatment regimens. The study showed that a daily dose of 30 mg of iron bisglycinate significantly increased serum ferritin levels — from 24.1 to 32.3 ng/mL by day 15, with a mean ferritin concentration of 39.1 ng/mL on day 60 (p 0.001). A statistically significant difference in the frequency of adverse events was observed between groups: 16 (26.7%) in the main group and 37 (61.7%) in the control group (p 0.001). CONCLUSION: The dietary supplement VitaFerr may be considered an effective and safe option for the prevention and treatment of iron deficiency and anemia.