Nutritional Stimulation of Growth in Children With Short Stature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Linear Growth
研究概览
简要总结
Short stature is a frequent reason for referral to a pediatric endocrinology clinic. Short stature is especially prevalent among those with failure to thrive (whose weight is significantly below the average weight of his/her peers). The growth hormone has limited efficacy for medical treatment of short stature when the cause of short stature is not growth hormone deficiency. This study will investigate the effect of 6 months of nutritional supplement (essential amino acids) compared to placebo in the linear growth of short children who have not yet reached puberty.
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 (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 3 to 11 years (inclusive).
- •Pre-pubertal status (i.e. Tanner stage 1 for breast development for girls and testicular enlargement for boys and pubic hair for both sexes).
- •Exclusion criteria:
- •Ages younger than 3 years or older than 11 years.
- •Medical history of a neurologic, endocrinologic, genetic, or metabolic problem known to have a direct effect on height growth. This includes, but is not limited to, children with a Growth hormone deficiency, Down syndrome, Turner syndrome, Russel-Silver syndrome, Prader-Willi syndrome, Pseudohypoparathyroidism, chronic kidney disease, malabsorptive syndromes, cancer survivors, etc.
- •Currently being treated or previously treated with Growth hormone, or history of oral steroid treatment within the last 3 months.
- •Being in puberty.
排除标准
- 未提供
结局指标
主要结局
Linear Growth
时间窗: 6 months
Growth velocity (cm/year) will be calculated and compared between arms using the height measurements taken before and after 6 months of Essential Amino Acids vs Placebo supplementation.
次要结局
- Body Composition(6 months)