Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sickle Cell Disease
- Sponsor
- Centre Hospitalier Régional d'Orléans
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- The change in the mean Bone Mineral Density of the two randomized groups
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed 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 15-20% * 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 : 1. / 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 2. / Creation of a sero-type blood bank for future research
Investigators
Eligibility Criteria
Inclusion Criteria
- •Following genotypes of sickle cell disease: SS, SC, SE, Sbeta + or Sbeta0
- •Ages 3 to 16 years old
Exclusion Criteria
- •Overweight at the start of the study
- •Child for whom one of the 2 parents refuses his child's participation in the study
Outcomes
Primary Outcomes
The change in the mean Bone Mineral Density of the two randomized groups
Time Frame: Month 12
The change in the mean Bone Mineral Density of the two randomized groups will be measured by biphotonic absorptiometry (in g/cm2).
Secondary Outcomes
- 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)