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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 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
研究组 & 干预措施
ODF Iron Supplement
ODF iron supplement contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 400 μg of folic acid.
干预措施: ODF Iron Supplement (Dietary Supplement)
Iron Supplement in Capsule
Iron supplement in capsule contains 30 mg of elemental iron (corresponding to 120 mg of ferric pyrophosphate) and 70 mg of vitamin C.
干预措施: Iron Supplement in Capsules (Dietary Supplement)
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 hematocrit(Day 0, Week4, Week 8)
- 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)