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

NCT04754711 | Completed

• 1 other identifier: CHRO-2020-17
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Osteoporosis; Osteopenia

Keywords

Sickle cell disease; Osteoporosis; Osteopenia; bone mineral density; Nutrition; body composition; Oral nutritional supplement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (28)

• Change in body composition

  Baseline

• Change in body composition

  Month 12

• Rate of participants with Change of Height

  Baseline

• Rate of participants with Change of Height

  Month 12

• Rate of participants with Change of Weight

  Baseline

Study Arms (2)

Group with oral nutritional supplement

EXPERIMENTAL

Group 1: receiving an oral nutritional supplement to increase calorie intake by around 20%

Dietary Supplement: Oral Nutritional Supplement

Control group

NO INTERVENTION

Group 2: "controls" receiving normal calorie intake without oral nutritional supplement

Interventions

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.

Group with oral nutritional supplement

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Following genotypes of sickle cell disease: SS, SC, SE, Sbeta + or Sbeta0
• Ages 3 to 16 years old

You may not qualify if:

• Overweight at the start of the study
• Child for whom one of the 2 parents refuses his child's participation in the study

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR Orléans

Orléans, France

Location

Related Publications (8)

• 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.

  PMID: 15683091 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.

  PMID: 20233970 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.

  PMID: 20331952 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.

  PMID: 22099364 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.

  PMID: 22089617 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.

  PMID: 24094945 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.

  PMID: 20194891 BACKGROUND

• 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.

  PMID: 38580373 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Osteoporosis; Bone Diseases, Metabolic

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Georges DIMITROV, Dr

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: September 23, 2021
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the publication of the original research

Locations

FR (1)