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

Osteoporosis Clinical Trial

— NUTRIDREP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04754711
• Other study ID #: CHRO-2020-17
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Bone Diseases, Metabolic
• Osteopenia
• Osteoporosis
• Sickle Cell Disease

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