Safety, Tolerability and Efficacy of Melt-In-Mouth Oral Iron and Folic Acid Supplement in an Urban Non-Pregnant Population

Abstract

Hema Divakar1 , Rita Singh2 , Poorni Narayanan3 , Divakar G. V.4 , Shyam Sundar Pani5 , Twinkle Bellani6 , Raksha Suvarna7

ACKGROUND In this study, we determined the safety, tolerability, efficacy and compliance of ‘Positeve’ melt-in-mouth tablets, an oral iron preparation along with micronutrients crucial for healthy blood cells and women’s health. The tablets were administered to young girls and non-pregnant women as part of daily dietary supplementation in maintaining an anaemia free status as determined by measuring the haemoglobin status pre- and post-intervention. METHODS A prospective study was conducted (July 2019 - November 2019) at Divakars Speciality Hospital, Bengaluru, India. One hundred and seven subjects were enrolled as per the inclusion criteria. Baseline Hb levels were measured and additional measurements were recorded at the completion of the study period i.e. 6 weeks. A daily dose of melt-in-mouth tablets delivering 11.5 mg of elemental iron and 100 mcg of folic acid (along with other micronutrients) was administered to the study participants, once daily, after meals, for a period of 6 weeks. RESULTS Of the 107 enrolled, 7 dropped out and were not available for follow up. Of the 100 study subjects, 58 women took Positeve melted mouth tablets regularly; 42 women were noted to be partially compliant. In 59 subjects, there was a haemoglobin raise of 0.1 g/dL - 0.6 g/dL. By applying students paired t test we could see that the difference was found to be statistically significant. In 32 subjects, there was a drop of 0.1 g/dL - 0.7 g/dL. In 4 subjects, it did not make any difference in their Hb level. No major side effects or anaphylactic reactions were noted during study period. CONCLUSIONS The findings of the study suggest that Positeve melt-in-mouths by Hlthistyl is safe and well tolerated and helps in maintaining iron sufficiency among young girls and non-pregnant women. The elemental iron formulated along with crucial micronutrients is suggested to be effective in the supplementary treatment of IDA among the young girls and non-pregnant women. Compliance is found to be better with minimal adverse effects.

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