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

Centre Hospitalier Régional d'Orléans72 enrolled

Overview

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.

* 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sickle Cell Disease Osteoporosis Osteopenia

Interventions

Oral Nutritional SupplementDIETARY_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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

CHR Orléans

Orléans, France

Outcomes

Primary Outcomes

The change in the mean Bone Mineral Density of the two randomized groups

The change in the mean Bone Mineral Density of the two randomized groups will be measured by biphotonic absorptiometry (in g/cm2).

Time frame: Baseline

The change in the mean Bone Mineral Density of the two randomized groups

The change in the mean Bone Mineral Density of the two randomized groups will be measured by biphotonic absorptiometry (in g/cm2).

Time frame: Month 12

Secondary Outcomes

Change in body composition

Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall

Time frame: Baseline

Change in body composition

Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall

Time frame: Month 12

Rate of participants with Change of Height

Height-to-age growth in cm and percentile according WHO

Time frame: Baseline

Rate of participants with Change of Height

Height-to-age growth in cm and percentile according WHO

Time frame: Month 12

Rate of participants with Change of Weight

Weight-to-age growth in kg and percentile according WHO

Time frame: Baseline

Rate of participants with Change of Weight

Data from ClinicalTrials.gov

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