Efficacy of an iron-fortified gummy on iron-deficiency anemia in young women

Abstract

Objective: We conducted this single-center, double-blinded, randomized and placebo-controlled study to explore the efficacy of an iron-fortified gummy on relieving iron-deficiency anemia in young Chinese women. Participants’ blood hemoglobin level was set as the primary outcome. The secondary objectives were to assess the effects of the iron-fortified gummy on participants’ blood iron levels, skin barrier functions, skin temperature regulating ability, menstruation and leucorrhea status, sleep quality, and overall quality of life.Methods: Seventy female participants aged 18-35 years with moderate iron-deficiency anemia (blood hemoglobin 90-120 g/L) were recruited and randomly assigned to an intervention group or a placebo group. We supplemented the diets of the participants with an iron-fortified gummy or a placebo for eight weeks. Their blood hemoglobin level, iron biomarkers, skin biophysical characteristics, hand temperature, self-reported menstruation and leucorrhea status, life quality and sleep quality were recorded at baseline, mid-way through the study and the end of the study. We compared the differences of the above outcomes between the intervention group and the control group. Results: After eight weeks of daily iron-fortified gummy intake, 80% of the participants showed improvement in blood hemoglobin concentration, with a mean increase of 14.5 g/L (95% confidence interval: 9.4, 19.5 g/L) compared to the control. Their serum iron and ferritin levels had significantly increased. They also had improved facial skin hydration and complexions, reduced transepidermal water loss, and accelerated temperature recovery in their hands. Intake of the iron-fortified gummy effectively reduced the incidence of menstrual headaches and insomnia. Participants reported prolonged sleep time, improved energy level, mobility, mental concentration, ability to engage in daily activities and work, as well as better perception of quality of life and health satisfaction.Conclusion:Daily consumption of the iron-fortified gummy over eight weeks could help build up blood iron levels to generate hemoglobin, relieve iron-deficiency anemia and related symptoms in young Chinese women. Intake of iron through gummy on a daily basis is an effective method to gradually increase the participants’ iron levels, leading to sustainable long-term benefits.Study registration: Chinese Clinical Trial Registry (ChiCTR2200061345).