NUTRIDREP: Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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Sickle cell disease is the most common inherited disease of the red blood cell
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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
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children with sickle cell disease have an increase in resting energy expenditure of 15-20%
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children with sickle cell disease have a significant decrease in muscle mass
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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 :
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/ 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
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/ Creation of a sero-type blood bank for future research
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group with oral nutritional supplement Group 1: receiving an oral nutritional supplement to increase calorie intake by around 20% |
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.
|
| No Intervention: Control group Group 2: "controls" receiving normal calorie intake without oral nutritional supplement |
Outcome Measures
Primary Outcome Measures
- The change in the mean Bone Mineral Density Z-score of the two randomized groups [Baseline]
The change in the mean Bone Mineral Density Z-score of the two randomized groups will be measured by biphotonic absorptiometry
- The change in the mean Bone Mineral Density Z-score of the two randomized groups [Month 12]
The change in the mean Bone Mineral Density Z-score of the two randomized groups will be measured by biphotonic absorptiometry
Secondary Outcome Measures
- Change in body composition [Month 12]
Change in body composition expressed by lean mass
- Rate of participants with stature growth [Month 12]
abnormal stature growth
- Rate of participants with weight growth [Month 12]
abnormal weight growth
- Rate of participants with school absenteeism [Month 12]
The level of school absenteeism measured by means of a questionnaire of school absenteeism
- The frequency of complications of sickle cell disease [Month 12]
Complications such as chronic pain, chronic and acute anemia, infections justifying hospitalization, multi visceral involvement.
- 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
- The presence or not of cerebral vasculopathy [Month 12]
The presence or not of a cerebral vasculopathy sought by transcranial Doppler
- an abnormal F-S-C hemoglobin level [Month 12]
- an abnormal high serum Lactate DeHydrogenase value [Month 12]
- a low serum iron and ferritin value [Month 12]
- an abnormal serum folate value [Month 12]
- an abnormal C Reactive Protein value [Month 12]
- a deficiency in 25-OH vitamin D [Month 12]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Homozygous sickle cell disease SS, SC, SE, Sbeta + or Sbeta0
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Ages 3 to 16 years old
Exclusion Criteria:
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Overweight at the start of the study
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Child for whom one of the 2 parents refuses his child's participation in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHR Orléans | Orléans | France |
Sponsors and Collaborators
- Centre Hospitalier Régional d'Orléans
Investigators
- Principal Investigator: Georges DIMITROV, Dr, CHR d'Orléans
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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. Review.
- Odièvre MH, Verger E, Silva-Pinto AC, Elion J. Pathophysiological insights in sickle cell disease. Indian J Med Res. 2011 Oct;134:532-7. Review.
- 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.
- 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. Review.
- 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. Review.
- CHRO-2020-17