Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Osteopenia
- Osteoporosis
- Sickle Cell Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomization of patients included in 2 groups Group 1: receiving an oral nutritional supplement to increase calorie intake by around 20% Group 2: "controls" receiving normal calorie intake without oral nutritional supplement Randomization will take into account age, gender and severity of disease in order to create two homogenous groups Monitoring by biphotonic absorptiometry, dietetic, clinical and biological Creation of a sero-type blood bank for the 2 groupsMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 3 years and 16 years
- Gender
- Both males and females
Description
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...
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
Tracking Information
- NCT #
- NCT04754711
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Georges DIMITROV, Dr CHR d'Orléans
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