A randomized open-label study to compare iron content in the blood of healthy subjects treated with Tasiron tablets containing ferric di-phosphate as compared to tablets containing ferrous ascorbate

Prashant Kulkarni, Sasikumar Menon
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Abstract

Iron deficiency anemia (IDA) frequently affects reproductive-age women, pregnant women, and children of growing age, particularly in developing countries like India. Traditional oral iron supplementation has various side effects, and therefore, liposomal technology has been introduced. This study compared serum iron levels in healthy adult female subjects treated with Tasiron tablets containing 30 mg (elemental iron) of micronized liposomal ferric di-phosphate, with those administered with tablets containing 100 mg (elemental iron) of ferrous ascorbate, over 15 days. The test group (n=7) received 30 mg of micronized liposomal ferric di-phosphate and the control group (n=7) received 100 mg of ferrous ascorbate. Serum levels of iron, hemoglobin, ferritin, and transferrin were measured from samples collected on days 1, 8, and 16 of the treatment periods. Higher iron content and hemoglobin levels were found at day 16 (p<0.05) and day 8 (p<0.05) as compared to day 1 in both groups. The test group received one-third the dose of iron that was administered to the control group. The group receiving 100 mg ferrous ascorbate had higher ferritin levels at day 8 (p<0.01) and day 16 (p<0.01) as compared to day 1. In the group receiving ferrous ascorbate, transferrin levels decreased on day 8 and 16. In contrast, there was an increase in transferrin levels in the group receiving liposomal iron. Oral liposomal iron effectively increases iron content and hemoglobin levels at one-third the concentration as compared to ferrous ascorbate. Further studies on larger numbers with a longer follow-up are required.
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一项随机开放标签研究,比较健康受试者服用含有二磷酸铁的塔西龙药片和含有抗坏血酸亚铁的药片后血液中的铁含量
缺铁性贫血(IDA)经常影响育龄妇女、孕妇和成长中的儿童,尤其是在印度等发展中国家。传统的口服铁补充剂有各种副作用,因此脂质体技术应运而生。这项研究比较了健康成年女性受试者在 15 天内服用含有 30 毫克(铁元素)微粉脂质体二磷酸铁的 Tasiron 片剂与服用含有 100 毫克(铁元素)抗坏血酸亚铁的片剂后的血清铁水平。试验组(7 人)服用 30 毫克二磷酸铁微粒体,对照组(7 人)服用 100 毫克抗坏血酸亚铁。在治疗期的第 1、8 和 16 天采集的样本中测量了血清中的铁、血红蛋白、铁蛋白和转铁蛋白水平。与第 1 天相比,两组在第 16 天(p<0.05)和第 8 天(p<0.05)的铁含量和血红蛋白水平都较高。试验组的铁剂量是对照组的三分之一。与第 1 天相比,服用 100 毫克抗坏血酸亚铁的试验组在第 8 天(p<0.01)和第 16 天(p<0.01)的铁蛋白水平更高。在服用抗坏血酸亚铁的组中,转铁蛋白水平在第 8 天和第 16 天有所下降。相比之下,接受脂质体铁治疗组的转铁蛋白水平有所上升。与抗坏血酸亚铁相比,口服脂质体铁能有效提高铁含量和血红蛋白水平,其浓度仅为抗坏血酸亚铁的三分之一。还需要对更多的患者进行更长时间的随访研究。
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