A Prospective, Single-Arm Study Evaluating the Efficacy and Safety of Bizfer XT(Ferrous Bisglycinate 60mg plus Zinc Bisglycinate 15mg plus Folic Acid 1mg plus Methylcobalamin 500mcg tablet) for the treatment of Iron Deficiency Anemia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Mean change in hemoglobin (Hb) levels from baseline to the end of treatment
研究概览
简要总结
This is a prospective, single-arm, open-label clinical study designed to evaluate the efficacy and safety of Bizfer-XT® tablets (containing Ferrous Bisglycinate 60 mg, Zinc Bisglycinate 15 mg, Folic Acid 1 mg, and Methylcobalamin 500 mcg) in the treatment of iron deficiency anemia (IDA) in adult women. The study will enroll non-pregnant, non-lactating female subjects aged 18 to 40 years who have a confirmed diagnosis of IDA, defined by hemoglobin levels between 8–11.9 g/dL, serum ferritin levels less than 30 ng/mL, and transferrin saturation less than 20%. Eligible subjects will receive one Bizfer-XT® tablet daily for a total duration of 8 weeks. Study visits will occur at baseline (Day 0), Week 4 (Day 28 ± 2), and Week 8 (Day 56 ± 2). The primary objective is to assess the mean change in hemoglobin levels from baseline to Week 8. Secondary objectives include evaluation of changes in serum ferritin and transferrin saturation, along with the assessment of safety and tolerability of the study medication. The results of this study aim to support the clinical utility of Bizfer-XT® in managing iron deficiency anemia among women of reproductive age
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Female subjects aged 18 to 40 years who are non-pregnant and non-lactating, confirmed by medical history and/or a negative urine pregnancy test.
- •Confirmed diagnosis of iron deficiency anemia (IDA), defined as: a.
- •Hemoglobin (Hb) level between 8–11.9 g/dL, and b.
- •Serum ferritin less than 30 ng/mL, and c.
- •Transferrin saturationless than 20%.
- •Willing to use effective contraception during the study period (if applicable).
- •Willing and able to provide written informed consent.
排除标准
- •Known history of any chronic uncontrolled systemic illnes.
- •Pregnant or lactating women, or those planning pregnancy during the study period
- •Known hypersensitivity or intolerance to iron, folic acid, methylcobalamin, zinc, or any component of the study medication.
- •Anemia due to non-iron deficiency causes, such as: a)Hemolytic anemia b)Aplastic anemia c)Megaloblastic anemia unrelated to iron deficiency d)Thalassemia or other hemoglobinopathies
- •Known history of chronic inflammatory conditions (e.g., rheumatoid arthritis, IBD) that may affect iron metabolism.
- •History of malabsorption syndromes (e.g., celiac disease, bariatric surgery) unless well-controlled.
- •Use of parenteral/oral iron therapy or blood transfusion in the past 12weeks.
- •Current use of other iron supplements or multivitamins containing iron.
- •Participation in another clinical trial within the past 30 days.
- •Any condition that, in the investigator’s judgment, may compromise safety, compliance, or study integrity.
结局指标
主要结局
Mean change in hemoglobin (Hb) levels from baseline to the end of treatment
时间窗: From baseline to end of study day 56
次要结局
- Mean change in serum ferritin levels(From baseline to end of study day 56)
- Mean change in serum iron and transferrin saturation (TSAT)(From baseline to end of study day 56)
- Change in fatigue symptoms as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale.(From baseline to end of study day 56)
- Percentage of participants achieving target Hb levels (Less than or equal to12 g/dL) by end of treatment.(At end of study day 56)
- Incidence of adverse events (AEs) and serious adverse events (SAEs) related to the study drug.(From baseline to end of study day 56)
研究者
Dr Jayesh Sanmukhani
Clinexcel Research