Effects of Growth Hormone Treatment on Eating Regulation and Comparison Between the Growth Responses With or Without Nutritional Intervention in Short Stature Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- height and weight
研究概览
简要总结
This is a two arm, randomized, prospective, intervention study in order to determine the effects of growth hormone treatment on eating regulation and to compare between the growth responses with or without nutritional intervention in short stature children.
The study will include 30 short stature children that are about to initiate growth hormone treatment and will last for one year. After 4 months of treatment, children will be randomized into two groups:
- Control group that will continue with growth hormone treatment without any other intervention.
- Study group that will be a given a nutritional intervention in addition to growth hormone treatment.
At screening visit and during the study the following parameters will be evaluated: height, weight, growth markers in the blood and urine, child eating behavior questionnaire, blood tests, hormonal tests and resting energy expenditure measurements.
详细描述
This is a two arm, randomized, prospective, intervention study in order to determine the effects of growth hormone treatment on eating regulation and to compare between the growth responses with or without nutritional intervention in short stature children.
Background:
In the last three decades children with different kinds of short stature pathologies were treated with growth hormone. Most of the attention in growth hormone studies is focused on the effect of the treatment on growth. Today there are very few studies that are focused on the effect of growth hormone on eating regulations and the connection between eating regulations and growth improvement in growth hormone treatment.
Objectives:
- To evaluate the effect of short term growth hormone treatment on the following parameters:
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Height of at least 2.0 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention (CDC).
- •Children that have one of the following short stature pathologies:
- •IGHD or MPHD
- •Proper function of thyroid gland, kidney and liver
- •Prior to initiating growth hormone treatment
排除标准
- •Chronic diseases
- •Diseases in the digestive system.
- •Neurological diseases.
- •Malignant diseases in the past or in the present. Treated with chemotherapy or radiation.
- •Genetic syndromes
- •Bone diseases
- •Taking chronic medicine, SSRI type, that effect the appetite and the growth hormone signal transduction.
结局指标
主要结局
height and weight
时间窗: every visit until the end of study
Growth markers
时间窗: At screening visit, baseline and at the end of the visit
次要结局
- Safety laboratory parameters(at screening, baseline and at the end of the study)
- food diary(every visit until the end of the study)
- Resting energy expenditure measurements(Every visit other than visit number 4)