Nutrients and Hormones: Effects in Boys With Disordered Growth
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in height, weight, and body composition
研究概览
简要总结
The purpose of the study is to find out if patients with constitutional delay of growth have a mismatch between energy intake and utilization (as measured by doubly labeled water) and to compare the improvement in growth and energy balance between a group of boys treated with growth hormone (GH) alone versus those given GH plus added nutritional supplements for one year.
详细描述
Two groups of boys 7-10 years old who are very short and below average in weight but otherwise healthy will be studied. One group will be observed initially for 6 months and then receive GH injections every day for the subsequent 12 months. Another group of boys will get a high-calorie drink every day for 6 months, and then receive GH injections plus the supplement every day for the next 12 months. We will compare how well boys grow in height, weight and the changes in body composition. We will compare diet and energy usage using the doubly labeled water technique. A battery of hormonal and nutritional tests will be performed, as well as body composition assessment.
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
- None
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Boys 7-10 years old who are very short and below average in weight but otherwise healthy.
- •Delay in skeletal maturation > 1 year.
排除标准
- •Growth hormone deficiency
- •Chronic illness
- •Participation in high endurance athletics
研究组 & 干预措施
Nutrition and Growth Hormone
干预措施: Pediasure (Drug)
Nutrition and Growth Hormone
干预措施: GH (Drug)
Observation and Growth Hormone
干预措施: GH (Drug)
结局指标
主要结局
Change in height, weight, and body composition
时间窗: 6month, 12month, 18month
次要结局
- Changes in total energy expenditure(6month, 12month)
研究者
Nelly Mauras
Chief, Division of Endocrinology, Diabetes & Metabolism
Nemours Children's Clinic