NCT05989984已完成不适用
Monocentric, Prospective, Randomized Study to Evaluate the Efficacy of a New Iron Supplement with Orodispersible Formulation Vs an Iron Supplement in Capsules in Subjects with Mild Anemia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product)
研究概览
简要总结
The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation vs an iron supplement in capsules in subjects with mild anemia.
详细描述
The aim of the study is to evaluate the efficacy of a new iron supplement with orodispersible formulation in modulating peripheral blood biomarkers of iron levels in subjects with mild anemia after 8 weeks of supplementation, compared to baseline values and also aims to evaluate its acceptability. For the evaluation, an iron supplement in capsules will be used as a comparison supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking procedure will be applied
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed prior to inclusion in the study
- •18-55 years
- •Ability to understand the nature and the purpose of the study, including possible risks and side effects
- •Capability to collaborate with the investigator and meet the requirements of the entire study
- •Subjects with mild anemia (with WHO hemoglobin values between 11-11.9 g/dl for women and between 11-12.9 g/dl for men)
排除标准
- •Clinically significant abnormalities in the ECG evaluation
- •Clinically significant abnormal laboratory values indicative of disease
- •Known allergy or presumed hypersensitivity to the food supplement investigated (iron) and / or to the excipients of the two formulations
- •History of anaphylaxis from drugs, dietary supplements or allergic reactions in general, which the investigator believed could influence the outcome of the study
- •Significant history of kidney, liver, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the purpose of the study
- •Taking herbal remedies and dietary supplements (including iron supplements, supplements with vitamin C, supplements with folic acid, supplements with vitamin B12, multivitamins) in the 2 weeks prior to the start of the study
- •Taking corticosteroids, thyroid hormones, antibiotics, antiepileptics
- •Alcohol abuse
- •Any clinical condition that in the investigator's judgment is deemed incompatible with study participation
- •Women who are pregnant or breastfeeding
结局指标
主要结局
Change from baseline in blood concentration of hemoglobin with ODF iron supplement (test product)
时间窗: Day 0, Week 8
Change from baseline in blood concentration of hemoglobin after 8 weeks of supplementation with ODF iron supplement
次要结局
- Change from baseline in blood concentration of transferrin(Day 0, Week4, Week 8)
- Change from baseline in mean corpuscolar volume (MCV)(Day 0, Week4, Week 8)
- Change from baseline in blood concentration of ferritin(Day 0, Week4, Week 8)
- Change from baseline in blood concentration of hemoglobin with test product(Day 0, Week 4)
- Change from baseline in blood concentration of transferrin receptor(Day 0, Week4, Week 8)
- Change from baseline in blood concentration of folic acid(Day 0, Week4, Week 8)
- Change from baseline in blood concentration of serum iron(Day 0, Week4, Week 8)
- Change from baseline in blood concentration of hemoglobin with Iron supplement in capsule (reference product)(Day 0, Week4, Week 8)
- Change from baseline in blood concentration of hematocrit(Day 0, Week4, Week 8)
研究者
研究点 (2)
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