An open-label, randomized, parallel arm, comparative clinical study to evaluate efficacy of iron supplement formulations in pregnant women affected by iron deficiency anemia.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Changes in hemoglobin levels
研究概览
简要总结
This study aims to address the pressing issue of IDA in pregnant women by focusing on efficacy. Iron pyrophosphate, recognized as "generally recognized as safe (GRAS)" by the United States Food and Drug Administration (USFDA) Code of Federal Regulation and the European Food Safety Authority (EFSA), holds promise due to its advantages over conventional oral iron salts, including increased bioavailability and reduced gastrointestinal side effects. The choice of iron supplement formulation is critical as it can significantly impact treatment efficacy, tolerability, and patient adherence. While various formulations, such as tablets and capsules, are available for clinical use, there’s a notable lack of comprehensive comparative data, especially concerning pregnant women with IDA. This investigation seeks to fill this gap by assessing the efficacy of EMFP tablets specifically during the second trimester of singleton pregnancies. By comparing the effects of a 30 mg EMFP tablet formulation with a capsule formulation, the study aims to establish a clear understanding of their relative efficacy. Such a comparison allows for a robust evaluation of which EMFP formulation offers superior efficacy in improving hemoglobin levels and alleviating IDA symptoms, thereby enhancing clinical relevance. Furthermore, by examining adverse events associated with both formulations, the study can provide insights into the overall safety profile of EMFP tablets, essential for informed decision-making by healthcare providers. Additionally, exploring patient preferences and adherence to each formulation could offer valuable insights into their clinical utility and acceptability. Conducting a comparative study provides a comprehensive assessment of the efficacy, safety, and practicality of the investigational treatment, thereby guiding clinical practice and ultimately improving patient care
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
- 20.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Participants meeting all of the following criteria will be eligible for the study:
- •Pregnant females with the age between 20-35 years (both inclusive);
- •Presence of a live, singleton, intrauterine fetus and dating ultrasound at screening that indicates a pregnancy that would be between the week 13 to week 16 (both inclusive);
- •Female with primi or multigravida;
- •Pregnant females without any other comorbidity;
- •Hemoglobin levels between 9-10.5 g/dl (both inclusive);
- •Serum ferritin levels below 15 mcg/L;
- •Able to give written informed consent;
- •Able to follow up through visits.
排除标准
- •Participants meeting any of the following criteria will not be eligible for the study:
- •Pregnant women of less than 13 weeks and more than 16 weeks of gestation;
- •Pregnant female with complicated pregnancy history or ongoing treatment for the same;
- •Pregnant women with complications like bleeding piles, excessive emesis, active peptic ulcer, diabetes, hypertension, eclampsia, hypothyroidism, hyperthyroidism and multiple pregnancy;
- •Participants on any concomitant therapy for treating IDA during study period;
- •Not willing to provide consent or follow up;
- •Any condition from investigator viewpoint can affect participant participation in the study.
结局指标
主要结局
Changes in hemoglobin levels
时间窗: at screening and end of the study.
次要结局
- 1. Changes in ferritin levels.(2. Changes in fatigue severity score.)
研究者
Dr Jyothi GS
Kala Hospital and Clinical laboratory