Iron Supplement Effect Over Immune System and Neurobehavioral Child Development.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 主要终点
- Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months.
研究概览
简要总结
Objective: To evaluate the effect of Iron supplement with two different amounts (one in the higher limit and another in the lower limit of the suggested amount) according to the presence of mutations in the HFE gene in the physical, immune and neurobehavioral development in the 6 to 12 moth toddlers.
Methodology: Subjects: 340 toddlers coming from Paediatric Serves of Sant Joan Hospital. Methods: At 6 and 12 months it done clinical history, food registry, biochemist determinations: haemoglobin, iron, transferrin, ferritin, reactive C protein and immune response (IL4, IL10, IL6 IFN, IgA, IgM, IgG, IgE). Mutations in the HFE gene: C282Y, H63D, S65D and hepcidin gene. Mental, psychomotor and behavioual development (Bayley Scales of Infant Development 2on Edition: 1993). We evaluate the level of language and communication (MacArthur), regulation and sensory process (Infant Toddler Symptom Checklist), familiar and environment surroundings (Scale Health General Parental Stress Index).
详细描述
Design: Randomised Clinical Trial with two groups of intervention. Group A received high-iron fortified milk (1.2mg/100mL) and Group B received low-iron fortified milk (0.4mg/100mL).
Inclusion criteria: caucasian new-borns, term infants.
Exclusion criteria:
- Families that refuse enter at the follow-up.
- Low-birth weight or preterm infants.
- Anaemic infants.
- Infants with congenital defects, immunodeficiency or hypothyroidism.
- Infants with diseases that requires intensive care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian infants
- •Healthy term infants
排除标准
- •Families that do not understand Spanish or Catalan
- •Anaemic infants at birth
- •Infants with important diseases
结局指标
主要结局
Mental and psychomotor development with BSID (Bayley Scale of Infant Development) at 12 months.
时间窗: 12 months
次要结局
- Risk of infections at 12 months measured qualitatively from record of presence or not of various infections as bronchitis, rhinitis, otitis etc.(12 months)
- Height at 12 months measured in centimeters(12 months)
- Weight at 12 months measured in grams(12 months)
- Head circumference at 12 months measured in centimeters(12 months)
研究者
Victoria Arija Val
University Professor
University Rovira i Virgili