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

Not Applicable

Active, not recruiting

• Conditions: Osteoporosis; Sickle Cell Disease; Osteopenia
• Interventions: Dietary Supplement: Oral Nutritional Supplement

• Registration Number: NCT04754711
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-15
• Study Start: 2021-09-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Primary Completion: 2025-03-23
• Study Completion: 2025-03-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Following genotypes of sickle cell disease: SS, SC, SE, Sbeta + or Sbeta0
• Ages 3 to 16 years old

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group with oral nutritional supplement	Oral Nutritional Supplement	Group 1: receiving an oral nutritional supplement to increase calorie intake by around 20%

Primary Outcome Measures

Name	Time	Method
The change in the mean Bone Mineral Density of the two randomized groups	Month 12	The change in the mean Bone Mineral Density of the two randomized groups will be measured by biphotonic absorptiometry (in g/cm2).

Secondary Outcome Measures

Name	Time	Method
Rate of participants with Change of Height	Month 12	Height-to-age growth in cm and percentile according WHO
Change in body composition	Month 12	Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall
The presence or not of cerebral vasculopathy	Month 12	The presence or not of a cerebral vasculopathy sought by transcranial Doppler
The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease	Month 12	The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease determined by echocardiography
Value change of serum iron and ferritin	Month 12
Value change of serum folate	Month 12
Value change of serum C Reactive Protein value	Month 12
Value change of F-S-C hemoglobin	Month 12
Value change of serum Lactate DeHydrogenase value	Month 12
Value change of serum 25-OH vitamin D	Month 12
Rate of participants with Change of Weight	Month 12	Weight-to-age growth in kg and percentile according WHO
Assessment of school absenteeism	Month 12	Questionnaire of school absenteeism
The frequency of complications of sickle cell disease	Month 12	Complications such as chronic pain, acute anemia, infections

Trial Locations

Locations (1)

CHR Orléans; 🇫🇷 Orléans, France