Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 :
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with oral nutritional supplement | Experimental | Group 1: receiving an oral nutritional supplement to increase calorie intake by around 20% |
|
| Control group | No Intervention | Group 2: "controls" receiving normal calorie intake without oral nutritional supplement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Nutritional Supplement | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body composition | Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall | Baseline |
| Change in body composition | Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Georges DIMITROV, Dr | CHR d'Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR Orléans | Orléans | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15683091 | Background | 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. | |
| 20233970 | Background | 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. |
Not provided
Not provided
After the completion and publication of the original study, anonymised data will be made available upon reasonable request to the corresponding author.
After the publication of the original research
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided
Randomization of patients included in 2 groups
Monitoring by biphotonic absorptiometry, dietetic, clinical and biological
Creation of a sero-type blood bank for the 2 groups
Not provided
Not provided
Not provided
Not provided
|
| Month 12 |
| Rate of participants with Change of Height | Height-to-age growth in cm and percentile according WHO | Baseline |
| Rate of participants with Change of Height | Height-to-age growth in cm and percentile according WHO | Month 12 |
| Rate of participants with Change of Weight | Weight-to-age growth in kg and percentile according WHO | Baseline |
| Rate of participants with Change of Weight | Weight-to-age growth in kg and percentile according WHO | Month 12 |
| Assessment of school absenteeism | Questionnaire of school absenteeism | Baseline |
| Assessment of school absenteeism | Questionnaire of school absenteeism | Month 3 |
| Assessment of school absenteeism | Questionnaire of school absenteeism | Month 6 |
| Assessment of school absenteeism | Questionnaire of school absenteeism | Month 9 |
| Assessment of school absenteeism | Questionnaire of school absenteeism | Month 12 |
| The frequency of complications of sickle cell disease | Complications such as chronic pain, acute anemia, infections | Month 12 |
| 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 |
| 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 |
| The presence or not of cerebral vasculopathy | The presence or not of a cerebral vasculopathy sought by transcranial Doppler | Baseline |
| The presence or not of cerebral vasculopathy | The presence or not of a cerebral vasculopathy sought by transcranial Doppler | Month 12 |
| Value change of F-S-C hemoglobin | Baseline |
| Value change of F-S-C hemoglobin | Month 12 |
| Value change of serum Lactate DeHydrogenase value | Baseline |
| Value change of serum Lactate DeHydrogenase value | Month 12 |
| Value change of serum iron and ferritin | Baseline |
| Value change of serum iron and ferritin | Month 12 |
| Value change of serum folate | Baseline |
| Value change of serum folate | Month 12 |
| Value change of serum C Reactive Protein value | Baseline |
| Value change of serum C Reactive Protein value | Month 12 |
| Value change of serum 25-OH vitamin D | Baseline |
| Value change of serum 25-OH vitamin D | Month 12 |
| 20331952 | Background | 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. |
| 22099364 | Background | 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. |
| 22089617 | Background | 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. |
| 24094945 | Background | 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. |
| 20194891 | Background | 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. |
| 38580373 | Derived | 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. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |