Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The change in the mean Bone Mineral Density of the two randomized groups
研究概览
简要总结
This study is design to assess the effects of an increase in nutritional intake on the bone mineral density of children with sickle cell disease, for 12 months.
详细描述
- Sickle cell disease is the most common inherited disease of the red blood cell
- During sickle cell disease, the decrease in Bone Mineral Density (BMD) in children is very common: 19 and 56% depending on the studies
- children with sickle cell disease have an increase in resting energy expenditure of 15-20%
- children with sickle cell disease have a significant decrease in muscle mass
- there are no specific nutritional recommendations for sickle cell disease in children
Our main purpose is to assess the effects of an increase in nutritional intake on the bone mineral density of children with sickle cell disease, for 12 months
Our secondary objectives are :
- / Evaluate the effects of an increase in nutritional intake on: body composition, height and weight growth, frequency of complications of sickle cell disease, school absenteeism, cardiac function, cerebral vasculopathy, biological parameters follow-up, and the relationship with the treatment started
- / Creation of a sero-type blood bank for future research
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
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Following genotypes of sickle cell disease: SS, SC, SE, Sbeta + or Sbeta0
- •Ages 3 to 16 years old
排除标准
- •Overweight at the start of the study
- •Child for whom one of the 2 parents refuses his child's participation in the study
研究组 & 干预措施
Group with oral nutritional supplement
Group 1: receiving an oral nutritional supplement to increase calorie intake by around 20%
干预措施: Oral Nutritional Supplement (Dietary Supplement)
Control group
Group 2: "controls" receiving normal calorie intake without oral nutritional supplement
结局指标
主要结局
The change in the mean Bone Mineral Density of the two randomized groups
时间窗: Month 12
The change in the mean Bone Mineral Density of the two randomized groups will be measured by biphotonic absorptiometry (in g/cm2).
The change in the mean Bone Mineral Density of the two randomized groups
时间窗: Baseline
The change in the mean Bone Mineral Density of the two randomized groups will be measured by biphotonic absorptiometry (in g/cm2).
次要结局
- Rate of participants with Change of Height(Month 12)
- Change in body composition(Month 12)
- The presence or not of cerebral vasculopathy(Month 12)
- The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease(Month 12)
- Value change of serum iron and ferritin(Month 12)
- Value change of serum folate(Month 12)
- Value change of serum C Reactive Protein value(Month 12)
- Value change of F-S-C hemoglobin(Month 12)
- Value change of serum Lactate DeHydrogenase value(Month 12)
- Value change of serum 25-OH vitamin D(Month 12)
- Rate of participants with Change of Weight(Month 12)
- Assessment of school absenteeism(Month 12)
- The frequency of complications of sickle cell disease(Month 12)
- Value change of serum Lactate DeHydrogenase value(Baseline)
- Value change of serum iron and ferritin(Baseline)
- Value change of serum folate(Baseline)
- Value change of serum C Reactive Protein value(Baseline)
- Change in body composition(Baseline)
- Value change of serum 25-OH vitamin D(Baseline)
- Rate of participants with Change of Height(Baseline)
- Rate of participants with Change of Weight(Baseline)
- Assessment of school absenteeism(Baseline)
- Assessment of school absenteeism(Month 3)
- Assessment of school absenteeism(Month 6)
- Assessment of school absenteeism(Month 9)
- The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease(Baseline)
- The presence or not of cerebral vasculopathy(Baseline)
- Value change of F-S-C hemoglobin(Baseline)