Osteopenia, Osteoporosis, Sickle Cell Disease
Conditions
Keywords
Sickle cell disease, Osteoporosis, Osteopenia, bone mineral density, Nutrition, body composition, Oral nutritional supplement
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
Interventions
DIETARY_SUPPLEMENTOral Nutritional Supplement
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.
Sponsors
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in the mean Bone Mineral Density of the two randomized groups | Baseline | The change in the mean Bone Mineral Density of the two randomized groups will be measured by biphotonic absorptiometry (in g/cm2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participants with Change of Height | Baseline | Height-to-age growth in cm and percentile according WHO |
| Rate of participants with Change of Weight | Baseline | Weight-to-age growth in kg and percentile according WHO |
| Assessment of school absenteeism | Baseline | Questionnaire of school absenteeism |
| The frequency of complications of sickle cell disease | Month 12 | Complications such as chronic pain, acute anemia, infections |
| The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease | Baseline | The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease determined by echocardiography |
| The presence or not of cerebral vasculopathy | Baseline | The presence or not of a cerebral vasculopathy sought by transcranial Doppler |
| Change in body composition | Baseline | Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall |
| 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 | — |
| Value change of serum 25-OH vitamin D | Baseline | — |
| Value change of F-S-C hemoglobin | Baseline | — |
Countries
France
Outcome results
None listed