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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04754711
Other study ID # CHRO-2020-17
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 23, 2021
Est. completion date March 23, 2024

Study information

Verified date February 2024
Source Centre Hospitalier Régional d'Orléans
Contact Georges DIMITROV, Dr
Phone +33238613390
Email georges.dimitrov@chr-orleans.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

Country Name City State
France CHR Orléans Orléans

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (7)

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

Outcome

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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