Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
NCT ID: NCT04754711
Last Updated: 2025-04-17
Study Results
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Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2021-09-23
2025-03-17
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
* 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
TREATMENT
NONE
Study Groups
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Group with oral nutritional supplement
Group 1: receiving an oral nutritional supplement to increase calorie intake by around 20%
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.
Control group
Group 2: "controls" receiving normal calorie intake without oral nutritional supplement
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Ages 3 to 16 years old
Exclusion Criteria
* Child for whom one of the 2 parents refuses his child's participation in the study
3 Years
16 Years
ALL
No
Sponsors
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Centre Hospitalier Régional d'Orléans
OTHER
Responsible Party
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Principal Investigators
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Georges DIMITROV, Dr
Role: PRINCIPAL_INVESTIGATOR
CHR d'Orléans
Locations
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CHR Orléans
Orléans, , France
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Conde M, Lespessailles E, Wanneveich M, Allemandou D, Boulain T, Dimitrov G. Effect of nutritional supplementation on bone mineral density in children with sickle cell disease: protocol for an open-label, randomised controlled clinical trial. BMJ Open. 2024 Apr 5;14(4):e080235. doi: 10.1136/bmjopen-2023-080235.
Other Identifiers
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CHRO-2020-17
Identifier Type: -
Identifier Source: org_study_id
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