Sickle Cell DiseaseNUTRIDREPNCT04754711
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
A study testing Oral Nutritional Supplement in people with Sickle Cell Disease and Osteoporosis, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Sickle Cell Disease, Osteoporosis, Osteopenia
- What is being tested?
- Oral Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2021to 17 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Following genotypes of sickle cell disease: SS, SC, SE, Sbeta + or Sbeta0
- Ages 3 to 16 years old
Who cannot join
- Overweight at the start of the study
- Child for whom one of the 2 parents refuses his child's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
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 :
- / 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
- Conditions
- Sickle Cell Disease, Osteoporosis, Osteopenia
- Being tested
- Oral Nutritional Supplement
- Keywords
- Sickle cell disease, Osteoporosis, Osteopenia, bone mineral density, Nutrition, body composition, Oral nutritional supplement
- Medical subject headings
- Anemia, Sickle Cell, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutritional SupplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Group with oral nutritional supplement | Experimental | Group 1: receiving an oral nutritional supplement to increase calorie intake by around 20% Receives: Dietary Supplement: Oral Nutritional Supplement |
| Control group | No intervention | Group 2: "controls" receiving normal calorie intake without oral nutritional supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Month 12
Secondary outcomes (28)
Change in body composition
Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall
Measured: Baseline
Change in body composition
Change in body composition expressed by lean mass (%), fat mass (%), bone mass, by region of the body and overall
Measured: Month 12
Rate of participants with Change of Height
Height-to-age growth in cm and percentile according WHO
Measured: Baseline
Rate of participants with Change of Height
Height-to-age growth in cm and percentile according WHO
Measured: Month 12
Rate of participants with Change of Weight
Weight-to-age growth in kg and percentile according WHO
Measured: Baseline
Rate of participants with Change of Weight
Weight-to-age growth in kg and percentile according WHO
Measured: Month 12
Assessment of school absenteeism
Questionnaire of school absenteeism
Measured: Baseline
Assessment of school absenteeism
Questionnaire of school absenteeism
Measured: Month 3
Assessment of school absenteeism
Questionnaire of school absenteeism
Measured: Month 6
Assessment of school absenteeism
Questionnaire of school absenteeism
Measured: Month 9
Assessment of school absenteeism
Questionnaire of school absenteeism
Measured: Month 12
The frequency of complications of sickle cell disease
Complications such as chronic pain, acute anemia, infections
Measured: Month 12
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
Measured: Baseline
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
Measured: Month 12
The presence or not of cerebral vasculopathy
The presence or not of a cerebral vasculopathy sought by transcranial Doppler
Measured: Baseline
The presence or not of cerebral vasculopathy
The presence or not of a cerebral vasculopathy sought by transcranial Doppler
Measured: Month 12
Value change of F-S-C hemoglobin
Measured: Baseline
Value change of F-S-C hemoglobin
Measured: Month 12
Value change of serum Lactate DeHydrogenase value
Measured: Baseline
Value change of serum Lactate DeHydrogenase value
Measured: Month 12
Value change of serum iron and ferritin
Measured: Baseline
Value change of serum iron and ferritin
Measured: Month 12
Value change of serum folate
Measured: Baseline
Value change of serum folate
Measured: Month 12
Value change of serum C Reactive Protein value
Measured: Baseline
Value change of serum C Reactive Protein value
Measured: Month 12
Value change of serum 25-OH vitamin D
Measured: Baseline
Value change of serum 25-OH vitamin D
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start23 Sep 2021
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georges DIMITROV, Dr, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754711
- Sponsor's protocol ID
- CHRO-2020-17
- Acronym
- NUTRIDREP
- Status last verified
- Apr 2025
- First submitted
- 9 Feb 2021
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the completion and publication of the original study, anonymised data will be made available upon reasonable request to the corresponding author.
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 15683091Weatherall 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 20233970Hassell 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 20331952Grosse 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 22099364Odievre 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 22089617Kanter 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 24094945Quinn 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 20194891Conde 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.
PubMed 38580373
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
- ClinicalTrials.gov ID
- NCT04754711
- Acronym / sponsor ID
- NUTRIDREP / CHRO-2020-17
- Conditions
- Sickle Cell Disease, Osteoporosis, Osteopenia
- Keywords
- Sickle cell disease, Osteoporosis, Osteopenia, bone mineral density, Nutrition, body composition, Oral nutritional supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 :
- / 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group with oral nutritional supplement | Experimental | Dietary Supplement: Oral Nutritional SupplementGroup 1: receiving an oral nutritional supplement to increase calorie intake by around 20% |
| Control group | No intervention | –Group 2: "controls" receiving normal calorie intake without oral nutritional supplement |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Following genotypes of sickle cell disease: SS, SC, SE, Sbeta + or Sbeta0
- Ages 3 to 16 years old
Key exclusion criteria (2 listed)
- Overweight at the start of the study
- Child for whom one of the 2 parents refuses his child's participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Nutritional SupplementWe 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. | Dietary supplement | Group with oral nutritional supplement |
Primary outcome
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).
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).
28 secondary outcomes
Change in body composition
Time frame: Baseline
Change in body composition
Time frame: Month 12
Rate of participants with Change of Height
Time frame: Baseline
Rate of participants with Change of Height
Time frame: Month 12
Rate of participants with Change of Weight
Time frame: Baseline
Rate of participants with Change of Weight
Time frame: Month 12
Assessment of school absenteeism
Time frame: Baseline
Assessment of school absenteeism
Time frame: Month 3
Assessment of school absenteeism
Time frame: Month 6
Assessment of school absenteeism
Time frame: Month 9
Assessment of school absenteeism
Time frame: Month 12
The frequency of complications of sickle cell disease
Time frame: Month 12
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
Time frame: Month 12
The presence or not of cerebral vasculopathy
Time frame: Baseline
The presence or not of cerebral vasculopathy
Time frame: Month 12
Value change of F-S-C hemoglobin
Time frame: Baseline
Value change of F-S-C hemoglobin
Time frame: Month 12
Value change of serum Lactate DeHydrogenase value
Time frame: Baseline
Value change of serum Lactate DeHydrogenase value
Time frame: Month 12
Value change of serum iron and ferritin
Time frame: Baseline
Value change of serum iron and ferritin
Time frame: Month 12
Value change of serum folate
Time frame: Baseline
Value change of serum folate
Time frame: Month 12
Value change of serum C Reactive Protein value
Time frame: Baseline
Value change of serum C Reactive Protein value
Time frame: Month 12
Value change of serum 25-OH vitamin D
Time frame: Baseline
Value change of serum 25-OH vitamin D
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Background: PubMed 15683091Schnog 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.
- Background: PubMed 20233970Weatherall 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.
- Background: PubMed 20331952Hassell 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.
- Background: PubMed 22099364Grosse 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.
- Background: PubMed 22089617Odievre MH, Verger E, Silva-Pinto AC, Elion J. Pathophysiological insights in sickle cell disease. Indian J Med Res. 2011 Oct;134(4):532-7.
- Background: PubMed 24094945Kanter 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.
- Background: PubMed 20194891Quinn 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.
- Derived from this study: PubMed 38580373Conde 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.
- Individual participant dataSharing planned: Yes. After the completion and publication of the original study, anonymised data will be made available upon reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges DIMITROV, Dr principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutritional Supplement in people with Sickle Cell Disease and Osteoporosis, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the mean Bone Mineral Density of the two randomized groups (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754711, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.