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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis; Sickle Cell Disease; Osteopenia
• Intervention / Treatment: Dietary supplement: Oral Nutritional Supplement

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 :

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

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georges DIMITROV, Dr; Phone Number: +33238613390; Email: georges.dimitrov@chr-orleans.fr

Study Locations

• France
  • Orléans, France
    • Recruiting
    • CHR Orléans
    • Contact: Georges DIMITROV, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Month 12
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	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 cerebral vasculopathy	The presence or not of a cerebral vasculopathy sought by transcranial Doppler	Baseline
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Investigators: Principal Investigator: Georges DIMITROV, Dr, CHR d'Orléans

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Estimated): March 23, 2024
• Study Completion (Estimated): March 23, 2024

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Nutrition; body composition; Osteoporosis; Sickle cell disease; bone mineral density; Osteopenia; Oral nutritional supplement
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Anemia; Bone Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Osteoporosis; Anemia, Sickle Cell; Bone Diseases, Metabolic
• Other Study ID Numbers: CHRO-2020-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the completion and publication of the original study, anonymised data will be made available upon reasonable request to the corresponding author.
• IPD Sharing Time Frame: After the publication of the original research
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No