Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition

Study Overview
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Brief Summary
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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
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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

Official Title
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Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition

Conditions
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Sickle Cell Disease, Osteoporosis, Osteopenia

Intervention / Treatment
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* Dietary Supplement: Oral Nutritional Supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Homozygous 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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group with oral nutritional supplement<br>Group 1: receiving an oral nutritional supplement to increase calorie intake by around 20% | Dietary Supplement: Oral Nutritional Supplement<br>* We will propose to the patients of group 1 several different oral nutritional supplements according to taste, and consistency of each child in order to optimize observance. Each of those different oral nutritional supplements will be adapted to the nutritional survey and the age of children without exceeding recommended intake of proteins, carbohydrates, lipids and micronutrients. Those patients will consume the Oral Nutritional Supplement during 12 months.<br>|
| No Intervention: Control group<br>Group 2: controls receiving normal calorie intake without oral nutritional supplement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the mean Bone Mineral Density Z-score of the two randomized groups | The change in the mean Bone Mineral Density Z-score of the two randomized groups will be measured by biphotonic absorptiometry | Baseline | 
| The change in the mean Bone Mineral Density Z-score of the two randomized groups | The change in the mean Bone Mineral Density Z-score of the two randomized groups will be measured by biphotonic absorptiometry | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body composition | Change in body composition expressed by lean mass | Month 12 | 
| Rate of participants with stature growth | abnormal stature growth | Month 12 | 
| Rate of participants with weight growth | abnormal weight growth | Month 12 | 
| Rate of participants with school absenteeism | The level of school absenteeism measured by means of a questionnaire of school absenteeism | Month 12 | 
| The frequency of complications of sickle cell disease | Complications such as chronic pain, chronic and acute anemia, infections justifying hospitalization, multi visceral involvement. | Month 12 | 
| The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease | The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease determined by echocardiography | Month 12 | 
| The presence or not of cerebral vasculopathy | The presence or not of a cerebral vasculopathy sought by transcranial Doppler | Month 12 | 
| an abnormal F-S-C hemoglobin level |  | Month 12 | 
| an abnormal high serum Lactate DeHydrogenase value |  | Month 12 | 
| a low serum iron and ferritin value |  | Month 12 | 
| an abnormal serum folate value |  | Month 12 | 
| an abnormal C Reactive Protein value |  | Month 12 | 
| a deficiency in 25-OH vitamin D |  | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopenia, Sickle cell disease, Osteoporosis, bone mineral density, Nutrition, body composition, Oral nutritional supplement