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

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ClinicalTrials.gov Identifier: NCT04754711
Recruitment Status : Not yet recruiting
First Posted : February 15, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Osteoporosis Osteopenia Dietary Supplement: Oral Nutritional Supplement Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023


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



Primary Outcome Measures :
  1. The change in the mean Bone Mineral Density Z-score of the two randomized groups [ Time Frame: Baseline ]
    The change in the mean Bone Mineral Density Z-score of the two randomized groups will be measured by biphotonic absorptiometry

  2. The change in the mean Bone Mineral Density Z-score of the two randomized groups [ Time Frame: Month 12 ]
    The change in the mean Bone Mineral Density Z-score of the two randomized groups will be measured by biphotonic absorptiometry


Secondary Outcome Measures :
  1. Change in body composition [ Time Frame: Month 12 ]
    Change in body composition expressed by lean mass

  2. Rate of participants with stature growth [ Time Frame: Month 12 ]
    abnormal stature growth

  3. Rate of participants with weight growth [ Time Frame: Month 12 ]
    abnormal weight growth

  4. Rate of participants with school absenteeism [ Time Frame: Month 12 ]
    The level of school absenteeism measured by means of a questionnaire of school absenteeism

  5. The frequency of complications of sickle cell disease [ Time Frame: Month 12 ]
    Complications such as chronic pain, chronic and acute anemia, infections justifying hospitalization, multi visceral involvement.

  6. 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

  7. The presence or not of cerebral vasculopathy [ Time Frame: Month 12 ]
    The presence or not of a cerebral vasculopathy sought by transcranial Doppler

  8. an abnormal F-S-C hemoglobin level [ Time Frame: Month 12 ]
  9. an abnormal high serum Lactate DeHydrogenase value [ Time Frame: Month 12 ]
  10. a low serum iron and ferritin value [ Time Frame: Month 12 ]
  11. an abnormal serum folate value [ Time Frame: Month 12 ]
  12. an abnormal C Reactive Protein value [ Time Frame: Month 12 ]
  13. a deficiency in 25-OH vitamin D [ Time Frame: Month 12 ]


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Ages Eligible for Study:   3 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754711


Contacts
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Contact: Georges DIMITROV, Dr +33238613390 georges.dimitrov@chr-orleans.fr

Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Georges DIMITROV, Dr CHR d'Orléans
Publications:
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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT04754711    
Other Study ID Numbers: CHRO-2020-17
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
Sickle cell disease
Osteoporosis
Osteopenia
bone mineral density
Nutrition
body composition
Oral nutritional supplement
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Anemia, Sickle Cell
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn