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PharmaLinea announced the publication of a new clinical trial demonstrating the safety and efficacy of its novel food supplement >Your< Iron Syrup.
PharmaLinea (Ljubljana, Slovenia) has announced the publication of a new clinical trial1 demonstrating the safety and efficacy of its novel food supplement >Your< Iron Syrup. In the double-blind, randomized, placebo-controlled trial, 94 children (in a 3:1 randomization ratio) between the ages of nine months and six years were given either the syrup containing 14 mg of elemental iron in the form of microencapsulated ferric iron, 0.7 mg of vitamin B6, and 1.25 µg of vitamin B12 as active ingredients per 5 mL of the product, or placebo, for 12 weeks. The children in the study were those that presented iron deficiencies without anemia or with mild microcytic hypochromic anemia not requiring medication.
The primary outcome assessed by researchers was the alleviation of iron deficiency, defined as a share of children having ferritin value >20 µg/L after 12 weeks of supplementation. Secondary outcomes assessed were the share of children of children with ferritin value >20 µg/L after 4 weeks of supplementation, as well as average changes in ferritin, hemoglobin, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC) after 4 and 12 weeks of supplementation.
Of the original 94 subjects, 64 children in the experimental group, and 21 children in the placebo group completed the trial. Results showed that after 12 weeks ferritin levels were significantly higher compared to baseline in both arms of the trial, increasing 55% in children taking >Your< Irony Syrup, compared to baseline, and 43% in children taking placebo. There were no statistically significant differences between the two groups. However, mean ferritin, hemoglobin level, and erythrocyte counts were significantly higher in the experimental group, compared to placebo. It’s also worth noting that 57% of the children in the placebo group retained suboptimal iron stores, while 45% of the children taking the iron supplement remained deficient. The researchers attribute this to the relatively low dosage used in the trial. One of the main takeaways from the study was that supplementation was effective in preventing the development of anemia in subjects. However, a larger study will be required to make a definitive assessment.