Cobalamin Status in Young Children With Gastrointestinal Symptoms or Feeding Problems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, growth parameters, symptom and neurological evaluation
研究概览
简要总结
During fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. During the last years we have detected cobalamin deficiency in a number of infants admitted to the Pediatric Department with various symptoms, including neurological symptoms and feeding problems. Cobalamin treatment is given to the infants with biochemical cobalamin deficiency, and leads to loss of symptoms and in improved physical condition.
In this study we want to establish the prevalence of cobalamin deficiency in infants with gastrointestinal symptoms and/or feeding problems. Cobalamin status will be investigated in all children aged 8 months and younger, admitted to the Pediatric Department with these symptoms. In a randomised intervention trial we will evaluate the effect of cobalamin supplementation in children with these symptoms and metabolic evidence of impaired cobalamin status.
Study hypothesis: Cobalamin treatment given to the infants with biochemical cobalamin deficiency, will lead to loss of symptoms and in improved physical condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 8 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children below 8 months of age
- •Clinical diagnosis or symptoms: feeding problems and/or gastrointestinal symptoms
排除标准
- •Children with syndromic disease
结局指标
主要结局
Outcome Measure: Changes in cobalamin and folate status, including metabolic markers, hematological parameters, growth parameters, symptom and neurological evaluation
时间窗: Reevalutation after 4 weeks
次要结局
- Maternal evaluation of changes in infant behaviour and symptoms(After 4 weeks)