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临床试验/CTRI/2025/07/091080
CTRI/2025/07/091080尚未招募不适用

Effectiveness of Iron Supplementation on Consecutive Day versus Alternate Day in women with Iron Deficiency Anemia-A Randomized Comparative study

SRM college of pharmacy1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
To assess whether alternate-day administration of iron supplement increases iron

研究概览

简要总结

In iron-depleted women without anemia, oral iron supplements induce an increase in serum hepcidin (SHep) that persists for 24 hours, decreasing iron absorption from supplements given later on the same or next day. Consequently, iron absorption from supplements is highest if iron is given on alternate days.

Whether this dosing schedule is also beneficial in women with iron-deficiency anemia (IDA) given high-dose iron supplements is uncertain.

The primary objective of this study was to assess whether, in women with IDA, alternate-day administration on same dose iron increases iron absorption compared to consecutive-day iron administration.

Secondary objectives were to correlate iron absorption with SHep and iron status parameters. We performing an interventional study iron absorption in women with IDA (n=60) median hemoglobin 11.5 mg/dL, who received alternate days of ferrous sulfate given at 8 AM on days 2, 4 and 6 untill day 30 labeled with stable iron isotopes 57Fe, 58Fe and 54Fe; after a third-month incorporation period,.

Iron absorption on consecutive days  and alternate days was assessed by measuring erythrocyte isotope incorporation. For both doses, SHep was higher on alternate days In iron-depleted women, providing iron supplements daily as divided doses increases serum hepcidin and reduces iron absorption.

Providing iron supplements on alternate days and in single doses optimizes iron absorption and might be a preferable dosing regimen. These findings should be confirmed in iron-deficient anaemic patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • ➢Healthy women aged between 18-45 years with depleted iron stores (serum ferritin 25 ug/L or less) and haemoglobin levels (7-10.9 g/dl).
  • ➢ Women with normal Body mass index (since overweight or obese women have sub clinical inflammation) ➢ Should not have donated blood or plasma donations in previous 4 months.
  • ➢ Should not be on any medications that may interfere with iron absorption within two weeks of the study start.

排除标准

  • Women not willing to give the informed consent
  • Ferritin level > 40 ug/L
  • Any other chronic illness
  • Other causes of anaemic illness like Enlarged spleen (splenomegaly), Hemolysis, Porphyria., Sickle Cell Anaemia, Thalassemia.

结局指标

主要结局

To assess whether alternate-day administration of iron supplement increases iron

时间窗: At the end of 1st, 2nd and 3rd months

absorption compared to consecutive-day iron administration.

时间窗: At the end of 1st, 2nd and 3rd months

次要结局

  • To assess for the safety/tolerability of the iron supplementation in both the study(groups.)

研究者

发起方
SRM college of pharmacy
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Manikandan S

SRM College of Pharmacy

研究点 (1)

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