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

Centre Hospitalier Régional d'Orléans

Status: Completed

Conditions: Osteopenia; Osteoporosis; Sickle Cell Disease

Treatments: Dietary Supplement: Oral Nutritional Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT04754711

CHRO-2020-17

Details and patient eligibility

About

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.

Full 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

Enrollment: 72 patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Group with oral nutritional supplement

Experimental group

Description:

Group 1: receiving an oral nutritional supplement to increase calorie intake by around 20%

Treatment:

Dietary Supplement: Oral Nutritional Supplement

Control group

No Intervention group

Description:

Group 2: "controls" receiving normal calorie intake without oral nutritional supplement