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Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition (NUTRIDREP)

Primary Purpose

Sickle Cell Disease, Osteoporosis, Osteopenia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Oral Nutritional Supplement
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle cell disease, Osteoporosis, Osteopenia, bone mineral density, Nutrition, body composition, Oral nutritional supplement

Eligibility Criteria

3 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Homozygous 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

Sites / Locations

  • CHR OrléansRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group with oral nutritional supplement

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

The change in the mean Bone Mineral Density Z-score of the two randomized groups
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
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
Change in body composition expressed by lean mass
Rate of participants with stature growth
abnormal stature growth
Rate of participants with weight growth
abnormal weight growth
Rate of participants with school absenteeism
The level of school absenteeism measured by means of a questionnaire of school absenteeism
The frequency of complications of sickle cell disease
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
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
The presence or not of a cerebral vasculopathy sought by transcranial Doppler
an abnormal F-S-C hemoglobin level
an abnormal high serum Lactate DeHydrogenase value
a low serum iron and ferritin value
an abnormal serum folate value
an abnormal C Reactive Protein value
a deficiency in 25-OH vitamin D

Full Information

First Posted
February 9, 2021
Last Updated
May 5, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT04754711
Brief Title
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
Acronym
NUTRIDREP
Official Title
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
March 23, 2024 (Anticipated)
Study Completion Date
March 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed 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 : / 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 / Creation of a sero-type blood bank for future research

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Osteoporosis, Osteopenia
Keywords
Sickle cell disease, Osteoporosis, Osteopenia, bone mineral density, Nutrition, body composition, Oral nutritional supplement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization of patients included in 2 groups 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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group with oral nutritional supplement
Arm Type
Experimental
Arm Description
Group 1: receiving an oral nutritional supplement to increase calorie intake by around 20%
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Group 2: "controls" receiving normal calorie intake without oral nutritional supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Nutritional Supplement
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in the mean Bone Mineral Density Z-score of the two randomized groups
Description
The change in the mean Bone Mineral Density Z-score of the two randomized groups will be measured by biphotonic absorptiometry
Time Frame
Baseline
Title
The change in the mean Bone Mineral Density Z-score of the two randomized groups
Description
The change in the mean Bone Mineral Density Z-score of the two randomized groups will be measured by biphotonic absorptiometry
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Change in body composition
Description
Change in body composition expressed by lean mass
Time Frame
Month 12
Title
Rate of participants with stature growth
Description
abnormal stature growth
Time Frame
Month 12
Title
Rate of participants with weight growth
Description
abnormal weight growth
Time Frame
Month 12
Title
Rate of participants with school absenteeism
Description
The level of school absenteeism measured by means of a questionnaire of school absenteeism
Time Frame
Month 12
Title
The frequency of complications of sickle cell disease
Description
Complications such as chronic pain, chronic and acute anemia, infections justifying hospitalization, multi visceral involvement.
Time Frame
Month 12
Title
The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease
Description
The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease determined by echocardiography
Time Frame
Month 12
Title
The presence or not of cerebral vasculopathy
Description
The presence or not of a cerebral vasculopathy sought by transcranial Doppler
Time Frame
Month 12
Title
an abnormal F-S-C hemoglobin level
Time Frame
Month 12
Title
an abnormal high serum Lactate DeHydrogenase value
Time Frame
Month 12
Title
a low serum iron and ferritin value
Time Frame
Month 12
Title
an abnormal serum folate value
Time Frame
Month 12
Title
an abnormal C Reactive Protein value
Time Frame
Month 12
Title
a deficiency in 25-OH vitamin D
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Homozygous 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georges DIMITROV, Dr
Phone
+33238613390
Email
georges.dimitrov@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georges DIMITROV, Dr
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR Orléans
City
Orléans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georges DIMITROV, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15683091
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.
Results Reference
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PubMed Identifier
20233970
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.
Results Reference
background
PubMed Identifier
20331952
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.
Results Reference
background
PubMed Identifier
22099364
Citation
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.
Results Reference
background
PubMed Identifier
22089617
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.
Results Reference
background
PubMed Identifier
24094945
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.
Results Reference
background
PubMed Identifier
20194891
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.
Results Reference
background

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