What’s the news: >Your< Iron Syrup, a private label children’s iron supplement by PharmaLinea, has recently been clinically proven to increase ferritin levels in iron-deficient children by 69%, thus enabling them to avoid anemia. The study, published in MDPI Nutrients, is the first to show anemia in iron-deficient children can be avoided through supplementation.
Why is it important: Iron supplements are proven to be able to create high market growth and with clinical proof the opportunity is even bigger. Iron deficiency has an especially high incidence in Southeast Asia.
Who should read this: Pharmaceutical and food supplement brands, looking to expand their portfolio.
PharmaLinea has a rich history of success with their private label iron supplements, but now they have taken a step further by publishing a clinical trial on their liquid iron product for children. Matevž Ambrožič, Marketing & PR Director at PharmaLinea, explains: “Products from >Your< Iron Line have been successfully launched by companies such as subsidiaries of STADA and Teva in over 21 markets. However, the market opportunity is not very obvious to everyone, because iron supplements can be a relatively small and undeveloped market in certain countries and looking at market reports won’t help you notice it. Iron drugs usually dominate the market but we have seen many cases now where our products, or even competitors, are launched into the market and create market growth. For example, a partner of ours in Europe launched >Your< Iron Line and is now reaching 500.000 ordered units a year, in a market of under 20 million people. What is required is 3 key advantages: great taste, absence of side effects, and high efficacy. We wanted objective proof of the latter, hence the investment into a clinical trial.”
The trial PharmaLinea performed on >Your< Iron Syrup was a randomized, double-blind, placebo-controlled intervention. It sets a high quality standard, as it was carried out in 15 research centers and on a statistically significant number of non-anemic children (85). “No other trial on children’s iron deficiency is directly comparable. They are either performed on anemic subjects and/or with an iron dose that categorizes the product as a drug and not a supplement,” Ambrožič claims.
He goes on to say that pharmaceutical companies and their strict demands regarding scientific proof were the main reason for the clinical trial. “Our most successful clients promote our iron products through medical detailing and have high standards on the science behind products. We wanted this study to be a powerful tool to help their marketing and convince doctors. Around 15% of pre-school children are iron-deficient and not yet anemic and therefore can’t be prescribed with drugs. So far doctors have had no clinically proven supplements that they could recommend to them. They could only hope that the children’s iron levels will not drop to anemic. Our clinical study in now the first to prove anemia in children can be avoided by taking an iron supplement. This is why we think the study will be such an important differentiation factor to separate our iron products from the competition. Thankfully, results turned out to be exceptional, so the investment was worth it.”
The results of the trial can be summarized as follows:
Children that took >Your< Iron Syrup were able to increase their ferritin by 69% (14,5 μg/l -> 24,5μg/l) – to levels significantly above the threshold at risk of anemia (20 μg/l). The placebo group retained at-risk levels despite receiving dietary advice.
>Your< Iron Syrup group also showed significantly higher hemoglobin (p= 0,02), hematocrit (p= 0,02), and erythrocyte levels (p= 0,03). Several widely recognized biological indicators of iron status were thus significantly improved.
Compliance was 92% and there was no significant difference between the experiment arms. The latter is true for the frequency of side effects as well. Only one severe adverse event (abdominal pain) in 85 children in 12 weeks was evaluated as possibly linked to supplementation. The product was thus found to be very well tolerated and safe.