Efficacy of >Your< Iron Syrup Supplementation in Children With Iron Deficiency With or Without Mild Microcytic Anemia - a Double-Blind, Placebo-Controlled Multicentric Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 15
- 主要终点
- The proportion of children having ferritin >20 µg/l
研究概览
简要总结
The study evaluates the efficacy and safety of >Your< Iron Syrup, a novel iron-containing dietary supplement, in the management of dietary iron deficiency in children. The study is a randomized, double-blind, placebo-controlled intervention conducted in 16 research centers in Slovenia, collectively enrolling 92 eligible children. Eligibility of children for participation in the study will be determined by screening for hemoglobin and ferritin (combined with C-reactive protein) levels in a sample of capillary blood. Eligible children will receive basic dietary advice on how to increase the consumption of dietary iron and will be invited to participate in the study. Enrolled children will be randomized to either >Your< Iron Syrup arm or to placebo arm in a 3:1 ratio, respectively. Changes in body iron stores (ferritin) and in hematological indices as well as occurence of any adverse events will be monitored after 4 and 12 weeks of once-daily supplementation with either >Your< Iron Syrup or placebo.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 9 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 9 months to 6 years (inclusive).
- •Signed informed consent for screening and for enrollment (parent or legal guardian).
- •Iron deficiency with or without mild microcytic anemia not requiring treatment (ferritin ≤20 µg/l and Hb ≥ 100 g/l in a capillary blood sample).
排除标准
- •Hb <100 g/l.
- •Anemia due to a cause other than iron deficiency.
- •Vegan diet.
- •Any known concomitant chronic disease (e. g., chronic inflammation, chronic inflammatory bowel disease, malignancy, kidney and/or liver malfunction, lead poisoning).
- •Any known allergies to the components of the investigational product.
- •Any known medical, physical, or psychological condition that, in the opinion of the investigator, is incompatible with consumption of the investigational product and/or with the conduct of the study.
- •Participation in another clinical study less than 1 month before enrollment or current participation in another clinical study.
- •Current consumption of iron-containing medicines or dietary supplements.
研究组 & 干预措施
>Your< Iron Syrup
干预措施: >Your< Iron Syrup (Dietary Supplement)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
The proportion of children having ferritin >20 µg/l
时间窗: 12 weeks
Measurement of ferritin in a capillary blood sample (with concomitant measurement of CRP)
次要结局
- Average change in hematocrit (HCT)(4 weeks)
- Average change in hemoglobin (Hb)(4 weeks)
- Average change in mean corpuscular hemoglobin (MCH)(4 weeks)
- Average change in HCT(12 weeks)
- Assessment of safety(12 weeks)
- Average change in MCV(12 weeks)
- Average change in MCHC(12 weeks)
- Average change in mean corpuscular volume (MCV)(4 weeks)
- The proportion of children having ferritin >20 µg/l(4 weeks)
- Average change in Hb(12 weeks)
- Average change in MCH(12 weeks)
- Average change in mean corpuscular hemoglobin concentration (MCHC)(4 weeks)
- Assessment of safety(4 weeks)