CClinicalTrials.gg
Sign In
CompletedNCT04754711NUTRIDREPUpdated Apr 17, 2025

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

An interventional study of Oral Nutritional Supplement in Sickle Cell Disease, Osteoporosis and Osteopenia, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 1 site in France. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-04-17.

Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
3 Years to 16 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Sickle Cell Disease
  • Osteoporosis
  • Osteopenia

Keywords

  • Sickle cell disease
  • Osteoporosis
  • Osteopenia
  • bone mineral density
  • Nutrition
  • body composition
  • Oral nutritional supplement
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 72 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Centre Hospitalier Régional d'Orléans is the lead sponsor of 129 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • 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

  • No intervention
    Control group

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

Interventions

  • Dietary supplementOral 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline

  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).

    Time frame: Month 12

Secondary outcomes

  1. Change in body composition

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

    Time frame: Baseline

  2. Change in body composition

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

    Time frame: Month 12

  3. Rate of participants with Change of Height

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

    Time frame: Baseline

  4. Rate of participants with Change of Height

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

    Time frame: Month 12

  5. Rate of participants with Change of Weight

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

    Time frame: Baseline

  6. Rate of participants with Change of Weight

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

    Time frame: Month 12

  7. Assessment of school absenteeism

    Questionnaire of school absenteeism

    Time frame: Baseline

  8. Assessment of school absenteeism

    Questionnaire of school absenteeism

    Time frame: Month 3

  9. Assessment of school absenteeism

    Questionnaire of school absenteeism

    Time frame: Month 6

  10. Assessment of school absenteeism

    Questionnaire of school absenteeism

    Time frame: Month 9

  11. Assessment of school absenteeism

    Questionnaire of school absenteeism

    Time frame: Month 12

  12. The frequency of complications of sickle cell disease

    Complications such as chronic pain, acute anemia, infections

    Time frame: Month 12

  13. 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

    Time frame: Baseline

  14. 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

    Time frame: Month 12

  15. The presence or not of cerebral vasculopathy

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

    Time frame: Baseline

  16. The presence or not of cerebral vasculopathy

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

    Time frame: Month 12

  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

07

Study locations

1 site
  • CHR Orléans
    Orléans, France
08

References and documents

Publications

  • 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. PubMed 15683091 ↗
  • 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. PubMed 20233970 ↗
  • 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. PubMed 20331952 ↗
  • 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. PubMed 22099364 ↗
  • 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. PubMed 22089617 ↗
  • 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. PubMed 24094945 ↗
  • 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. PubMed 20194891 ↗

Individual participant data

Plan to share: Yes — After the completion and publication of the original study, anonymised data will be made available upon reasonable request to the corresponding author.

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04754711
Lead sponsor
Centre Hospitalier Régional d'Orléans
Responsible party
Sponsor
First posted
Feb 15, 2021
Start date
Sep 23, 2021
Primary completion
Mar 17, 2025
Completion
Mar 17, 2025
Last update
Apr 17, 2025

Study contacts

Georges DIMITROV, Dr
principal investigator · CHR d'Orléans

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Osteoporosis→

Other studies from this sponsor

Centre Hospitalier Régional d'Orléans

Start the discussion