An open-label, randomized, comparative study investigating efficacy and safety of iron supplement vs. ferrous ascorbate tablet in pregnant women with iron deficiency anemia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- 1. Changes in hemoglobin levels at screening week 4, week 8 and end of the study.
研究概览
简要总结
The rationale for this study lies in the need to address IDA in pregnant women with a focus on efficacy and safety. Iron pyrophosphate, recognized as “generally recognized as safe (GRAS)†by United States Food and Drugs Administration (USFDA) Code of Federal Regulation. and European Food Safety Authority (EFSA), presents promising advantages over conventional oral iron salts, including higher bioavailability and reduced gastrointestinal side effects.
This investigation seeks to assess the efficacy and safety of iron supplement SunActiveTM Fe tablet containing EMFP in managing IDA during the second trimester of singleton pregnancies. By comparing the effects of a 27 mg SunActiveTM Fe tablet containing EMFP formulation with a widely used ferrous ascorbate tablet, the study aims to establish the comparative efficacy of SunActiveTM Fe tablet. Such a comparison allows for a robust evaluation of whether SunActiveTM Fe tablets offer superior outcomes in terms of improving hemoglobin levels and alleviating IDA symptoms, thereby enhancing clinical relevance.
Additionally, the comparative nature of the study enables a comprehensive evaluation of the safety profile of SunActiveTM Fe tablets. By comparing adverse events and side effects between the investigational and standard treatments, the study can provide insights into the overall safety profile of SunActiveTM Fe tablet, which is crucial for informed decision-making by healthcare providers.
In essence, conducting a comparative study against a standard marketed drug provides a comprehensive assessment of the efficacy, safety, and clinical utility of the investigational treatment, thereby guiding clinical practice and 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); 2.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
1. Changes in hemoglobin levels at screening week 4, week 8 and end of the study.
时间窗: Screening, baseline, week 4, week 8 and end of the study
2. Adverse events profile from baseline to end of the study.
时间窗: Screening, baseline, week 4, week 8 and end of the study
次要结局
- 1.Changes in ferritin levels at screening, week 4, week 8 and end of the study.(2.Changes in fatigue severity score at screening, week 4, week 8 and end of the study.)
研究者
Dr Ameet Patki
Fertility Associates Clinic