NCT04754711

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 3 Years – 16 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sickle Cell Disease
• Osteoporosis
• Osteopenia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral 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.

Timeline

• Start date: 2021-09-23
• Primary completion: 2025-03-17
• Completion: 2025-03-17
• First posted: 2021-02-15
• Last updated: 2025-04-17

Locations

1 site across 1 country: France