Clinical trial NCT04754711: Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
Official title: Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Osteoporosis
Osteopenia
Keywords: Sickle cell disease
Osteoporosis
Osteopenia
bone mineral density
Nutrition
body composition
Oral nutritional supplement
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 72
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: The change in the mean Bone Mineral Density of the two randomized groups
timeFrame: Baseline
measure: The change in the mean Bone Mineral Density of the two randomized groups
timeFrame: Month 12
Secondary outcomes:
measure: Change in body composition
timeFrame: Baseline
measure: Change in body composition
timeFrame: Month 12
measure: Rate of participants with Change of Height
timeFrame: Baseline
measure: Rate of participants with Change of Height
timeFrame: Month 12
measure: Rate of participants with Change of Weight
timeFrame: Baseline
measure: Rate of participants with Change of Weight
timeFrame: Month 12
measure: Assessment of school absenteeism
timeFrame: Baseline
measure: Assessment of school absenteeism
timeFrame: Month 3
measure: Assessment of school absenteeism
timeFrame: Month 6
measure: Assessment of school absenteeism
timeFrame: Month 9
measure: Assessment of school absenteeism
timeFrame: Month 12
measure: The frequency of complications of sickle cell disease
timeFrame: Month 12
measure: The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease
timeFrame: Baseline
measure: The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease
timeFrame: Month 12
measure: The presence or not of cerebral vasculopathy
timeFrame: Baseline
measure: The presence or not of cerebral vasculopathy
timeFrame: Month 12
measure: Value change of F-S-C hemoglobin
timeFrame: Baseline
measure: Value change of F-S-C hemoglobin
timeFrame: Month 12
measure: Value change of serum Lactate DeHydrogenase value
timeFrame: Baseline
measure: Value change of serum Lactate DeHydrogenase value
timeFrame: Month 12
measure: Value change of serum iron and ferritin
timeFrame: Baseline
measure: Value change of serum iron and ferritin
timeFrame: Month 12
measure: Value change of serum folate
timeFrame: Baseline
measure: Value change of serum folate
timeFrame: Month 12
measure: Value change of serum C Reactive Protein value
timeFrame: Baseline
measure: Value change of serum C Reactive Protein value
timeFrame: Month 12
measure: Value change of serum 25-OH vitamin D
timeFrame: Baseline
measure: Value change of serum 25-OH vitamin D
timeFrame: Month 12
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR Orléans
Study officials:
affiliation: CHR d'Orléans
name: Georges DIMITROV, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schnog JB, Duits AJ, Muskiet FA, ten Cate H, Rojer RA, Brandjes DP. Sickle cell disease; a general overview. Neth J Med. 2004 Nov;62(10):364-74.
citation: Weatherall DJ. The inherited diseases of hemoglobin are an emerging global health burden. Blood. 2010 Jun 3;115(22):4331-6. doi: 10.1182/blood-2010-01-251348. Epub 2010 Mar 16.
citation: Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med. 2010 Apr;38(4 Suppl):S512-21. doi: 10.1016/j.amepre.2009.12.022.
citation: Grosse SD, Odame I, Atrash HK, Amendah DD, Piel FB, Williams TN. Sickle cell disease in Africa: a neglected cause of early childhood mortality. Am J Prev Med. 2011 Dec;41(6 Suppl 4):S398-405. doi: 10.1016/j.amepre.2011.09.013.
citation: Odievre MH, Verger E, Silva-Pinto AC, Elion J. Pathophysiological insights in sickle cell disease. Indian J Med Res. 2011 Oct;134(4):532-7.
citation: Kanter J, Kruse-Jarres R. Management of sickle cell disease from childhood through adulthood. Blood Rev. 2013 Nov;27(6):279-87. doi: 10.1016/j.blre.2013.09.001. Epub 2013 Sep 19.
citation: Quinn CT, Rogers ZR, McCavit TL, Buchanan GR. Improved survival of children and adolescents with sickle cell disease. Blood. 2010 Apr 29;115(17):3447-52. doi: 10.1182/blood-2009-07-233700. Epub 2010 Mar 1.