Effect of Heme Iron Polypeptide (HIP) in Iron Deficiency Anaemia among Pregnant Women: A Prospective Interventional Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean change in haemoglobin (g/dL)
研究概览
简要总结
This is a single arm, prospective, open label, interventional study to evaluate the effectiveness, safety, and tolerability of oral Heme Iron Polypeptide in pregnant women with mild to moderate iron deficiency anaemia during the second trimester. Sixty eligible pregnant women between twelve and eighteen weeks of gestation will receive Heme Iron Polypeptide twenty four milligrams once daily for twelve weeks along with routine calcium and multivitamin supplements. Participants will be followed up at baseline, week four, week eight, and week twelve for assessment of haemoglobin, serum ferritin, serum iron, transferrin saturation, and adverse events. The primary outcome is the mean change in haemoglobin from baseline to week twelve. Secondary outcomes include changes in iron parameters, effect of timing of calcium and multivitamin supplementation on haemoglobin response, safety, tolerability, and participant reported outcomes. The study aims to determine whether Heme Iron Polypeptide is an effective and well tolerated alternative for the treatment of iron deficiency anaemia in pregnancy.
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 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant woman aged 18 to 40 years.
- •Singleton pregnancy with gestational age between 12 to 18 weeks, confirmed by early trimester ultrasound.
- •Diagnosed with mild to moderate iron deficiency Anaemia, defined as Haemoglobin (Hb) between 8.0 and 10.9 g/dL and Serum ferritin less than 30 µg/L Belongs to either of the following two groups: Iron therapy-naïve: Has not yet received oral or parenteral iron during the current pregnancy Oral iron intolerant: Has received standard oral iron therapy for greater than 2 weeks and complained of GI intolerance.
- •Willing to provide written informed consent.
排除标准
- •Participants will be excluded if they have received parenteral iron therapy within the last four weeks; have known hypersensitivity to heme based products or previous reaction to HIP; have anemia due to other causes including hemoglobinopathies, vitamin B twelve deficiency, folate deficiency, chronic renal disease, active infection or inflammation, or chronic blood loss; have poorly controlled type two diabetes defined as random blood glucose equal to or greater than two hundred milligrams per deciliter at screening; have chronic hypertension defined as systolic blood pressure equal to or greater than one hundred forty millimeters of mercury or diastolic blood pressure equal to or greater than ninety millimeters of mercury at screening; have tuberculosis, viral hepatitis, human immunodeficiency virus infection, cirrhosis, malabsorption syndrome, cardiovascular disease, renal disease, autoimmune disease, cancer, or any other clinically significant systemic illness that may interfere with iron absorption or metabolism; or have participated in another interventional clinical study within the past thirty days.
结局指标
主要结局
Mean change in haemoglobin (g/dL)
时间窗: From baseline to end of visit 3 (week 12)
次要结局
- Mean change in haemoglobin (g/dL)(At visit 1 and 2 (week 4, 8 respectively from the start of treatment) compared to baseline visit)
- Mean change in serum ferritin(from baseline to final visit 3 (week 12))
- Mean change in serum iron(from baseline to final visit 3 (week 12))
- The effect of timing of calcium and multivitamin supplements on haemoglobin response by evaluating the mean change in haemoglobin (g/dL)(from baseline to visit 3 (week 12))
- change in numerical rating scale score regarding participant’s global assessment of disease(at each visit)
- Incidents of adverse effects to evaluate the safety and tolerability of HIP(at each visit)
研究者
Dr Sandhya Kamat
Seth G S Medical College and KEM Hospital