CTRI/2024/06/068631已完成Phase 3 4
Daily versus alternate day dosing of oral Ferrous sulphate in patients of iron deficiency anemia A Randomized open label non inferiority trial
Aiims Raipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月20日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean change in hemoglobin from baseline to end of study
研究概览
简要总结
The current trial proposes to evaluate the feasibility of performing this study to examine the effectiveness and side effect profile of oral iron once daily vs every other day.Cases will be recruited from pateints comming to general medicine opd with with hb less than 12 in case of female and less than 13 in case of male with serum ferritin less than 30mcg/L.Purpose of this trial is to evaluate the effectiveness of oral Ferrous sulfate 300mg once daily versus every otherday to improve hemoglobin at 12 weeks post-initiation in iron deficiency anemia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age ≥ 16 years 2.Outpatients with iron deficiency anemia are defined as hemoglobin less than 12.0 g/dL in females or less than 13.0 g/dL in males AND ferritin less than 30 mcg/L.
排除标准
- •Pregnancy and/or currently breastfeeding
- •Known history of inflammatory bowel disease, celiac disease, thalassemia or thalassemia trait, and/or inherited bleeding disorder
- •Known intolerance or lack of response to oral ferrous gluconate, sulfate, or fumarate in the last 12 weeks
- •Multivitamin and mineral supplements (35 mg or more of elemental iron per day) in 2 weeks prior to randomization
- •Allergy to oral iron
- •Allergy to any of the following medicinal and nonmedicinal ingredients in ferrous sulfate: ferrous sulfate, calcium citrate, crospovidone, and talc titanium dioxide
- •Intravenous iron therapy in the past 12 weeks
- •On new anticoagulant therapy initiated in the past 6 months (e.g., warfarin, apixaban, dabigatran, rivaroxaban)
- •Surgery, and/or chemotherapy planned in the upcoming 12 weeks
- •Previously enrolled in the study
- •Creatinine clearance less than 30 mL/min
- •Hemoglobin less than 8.0 g/dL with active bleeding (defined as WHO grade-2 bleeding or higher in the past week
- •Recent blood donation.
结局指标
主要结局
Mean change in hemoglobin from baseline to end of study
时间窗: 12weeks
次要结局
- Mean change in hemoglobin from baseline(4weeks)
- Proportion of patients showing an increase in hemoglobin >1.5g/dl(4 weeks)
- 3. Proportion of patients with normal hemoglobin level (>12g/dl or 13g/dl in females and males respectively)(at the end of the study)
- Incidence of treatment-emergent adverse events (TEAEs)(end of the study)
研究者
dr Pankaj Kannauje
All India Institute of Medical Sciences
研究点 (1)
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