Osteoporosis Clinical Trial
— NUTRIDREPOfficial title:
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | March 23, 2024 |
Est. primary completion date | March 23, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 16 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHR Orléans | Orléans |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional d'Orléans |
France,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in the mean Bone Mineral Density of the two randomized groups | The change in the mean Bone Mineral Density of the two randomized groups will be measured by biphotonic absorptiometry (in g/cm2). | Baseline | |
Primary | The change in the mean Bone Mineral Density of the two randomized groups | The change in the mean Bone Mineral Density of the two randomized groups will be measured by biphotonic absorptiometry (in g/cm2). | Month 12 | |
Secondary | Change in body composition | Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall | Baseline | |
Secondary | Change in body composition | Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall | Month 12 | |
Secondary | Rate of participants with Change of Height | Height-to-age growth in cm and percentile according WHO | Baseline | |
Secondary | Rate of participants with Change of Height | Height-to-age growth in cm and percentile according WHO | Month 12 | |
Secondary | Rate of participants with Change of Weight | Weight-to-age growth in kg and percentile according WHO | Baseline | |
Secondary | Rate of participants with Change of Weight | Weight-to-age growth in kg and percentile according WHO | Month 12 | |
Secondary | Assessment of school absenteeism | Questionnaire of school absenteeism | Baseline | |
Secondary | Assessment of school absenteeism | Questionnaire of school absenteeism | Month 3 | |
Secondary | Assessment of school absenteeism | Questionnaire of school absenteeism | Month 6 | |
Secondary | Assessment of school absenteeism | Questionnaire of school absenteeism | Month 9 | |
Secondary | Assessment of school absenteeism | Questionnaire of school absenteeism | Month 12 | |
Secondary | The frequency of complications of sickle cell disease | Complications such as chronic pain, acute anemia, infections | Month 12 | |
Secondary | The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease | The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease determined by echocardiography | Baseline | |
Secondary | The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease | The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease determined by echocardiography | Month 12 | |
Secondary | The presence or not of cerebral vasculopathy | The presence or not of a cerebral vasculopathy sought by transcranial Doppler | Baseline | |
Secondary | The presence or not of cerebral vasculopathy | The presence or not of a cerebral vasculopathy sought by transcranial Doppler | Month 12 | |
Secondary | Value change of F-S-C hemoglobin | Baseline | ||
Secondary | Value change of F-S-C hemoglobin | Month 12 | ||
Secondary | Value change of serum Lactate DeHydrogenase value | Baseline | ||
Secondary | Value change of serum Lactate DeHydrogenase value | Month 12 | ||
Secondary | Value change of serum iron and ferritin | Baseline | ||
Secondary | Value change of serum iron and ferritin | Month 12 | ||
Secondary | Value change of serum folate | Baseline | ||
Secondary | Value change of serum folate | Month 12 | ||
Secondary | Value change of serum C Reactive Protein value | Baseline | ||
Secondary | Value change of serum C Reactive Protein value | Month 12 | ||
Secondary | Value change of serum 25-OH vitamin D | Baseline | ||
Secondary | Value change of serum 25-OH vitamin D | Month 12 |
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