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NCT Number: NCT04754711

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

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Bone Diseases Bone Diseases, Metabolic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia Osteoporosis

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Orléans

Orléans, France

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The change in the mean Bone Mineral Density of the two randomized groups

    Time frame: Baseline

    The change in the mean Bone Mineral Density of the two randomized groups will be measured by biphotonic absorptiometry (in g/cm2).

  2. The change in the mean Bone Mineral Density of the two randomized groups

    Time frame: Month 12

    The change in the mean Bone Mineral Density of the two randomized groups will be measured by biphotonic absorptiometry (in g/cm2).

Secondary outcomes

  1. Change in body composition

    Time frame: Baseline

    Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall

  2. Change in body composition

    Time frame: Month 12

    Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall

  3. Rate of participants with Change of Height

    Time frame: Baseline

    Height-to-age growth in cm and percentile according WHO

  4. Rate of participants with Change of Height

    Time frame: Month 12

    Height-to-age growth in cm and percentile according WHO

  5. Rate of participants with Change of Weight

    Time frame: Baseline

    Weight-to-age growth in kg and percentile according WHO

  6. Rate of participants with Change of Weight

    Time frame: Month 12

    Weight-to-age growth in kg and percentile according WHO

  7. Assessment of school absenteeism

    Time frame: Baseline

    Questionnaire of school absenteeism

  8. Assessment of school absenteeism

    Time frame: Month 3

    Questionnaire of school absenteeism

  9. Assessment of school absenteeism

    Time frame: Month 6

    Questionnaire of school absenteeism

  10. Assessment of school absenteeism

    Time frame: Month 9

    Questionnaire of school absenteeism

  11. Assessment of school absenteeism

    Time frame: Month 12

    Questionnaire of school absenteeism

  12. The frequency of complications of sickle cell disease

    Time frame: Month 12

    Complications such as chronic pain, acute anemia, infections

  13. The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease

    Time frame: Baseline

    The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease determined by echocardiography

  14. The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease

    Time frame: Month 12

    The presence or not of impaired cardiac function and / or cardiac anatomy related to sickle cell disease determined by echocardiography

  15. The presence or not of cerebral vasculopathy

    Time frame: Baseline

    The presence or not of a cerebral vasculopathy sought by transcranial Doppler

  16. The presence or not of cerebral vasculopathy

    Time frame: Month 12

    The presence or not of a cerebral vasculopathy sought by transcranial Doppler

  17. Value change of F-S-C hemoglobin

    Time frame: Baseline

  18. Value change of F-S-C hemoglobin

    Time frame: Month 12

  19. Value change of serum Lactate DeHydrogenase value

    Time frame: Baseline

  20. Value change of serum Lactate DeHydrogenase value

    Time frame: Month 12

  21. Value change of serum iron and ferritin

    Time frame: Baseline

  22. Value change of serum iron and ferritin

    Time frame: Month 12

  23. Value change of serum folate

    Time frame: Baseline

  24. Value change of serum folate

    Time frame: Month 12

  25. Value change of serum C Reactive Protein value

    Time frame: Baseline

  26. Value change of serum C Reactive Protein value

    Time frame: Month 12

  27. Value change of serum 25-OH vitamin D

    Time frame: Baseline

  28. Value change of serum 25-OH vitamin D

    Time frame: Month 12

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Acronym: NUTRIDREP

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 15, 2021
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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