Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents (Obevidos)
Treatment of Vitamin D Deficit in Obese Children and Adolescents: a Multi-centre Open Label Randomized Controlled Study Comparing the Efficacy of Two Oral Supplementation Regimens: Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Level. A French-Swiss Collaboration
Childhood obesity prevalence is increasing and is a serious public health challenge. Indeed, according to INPES in 2006, overweight and obesity were affecting 18 % of French children between 3 and 17 years. 3 % of the boys and 4 % of the girls were classified as obese. Obese children are likely to develop chronic disease, starting at paediatric age, as cardiovascular or bone diseases, or type 2 diabetes.
Vitamin D deficiency is recognized to play an essential role in bone metabolism and arterial hypertension and type 2 diabetes development.
Obesity, in adults like in children, is associated with vitamin D deficiency. Common explanations for this low serum concentration of 25(OH)D in obese are the sequestration and/or the volumetric dilution of this lipid-soluble vitamin by adipose tissue. Therefore, obese population is at higher risk of developing cardiovascular and metabolic complications.
The nutrition comity of French Pediatric Society (SFP) edit vitamin D supplementation recommendations (2012) for adolescents at risk of deficit: supplementation by trimestral loading dose of 80 000 to 100 000 UI of vitamin D. However, for obese patients, the deficit is difficult to cure with classical loading doses. It seems that these patients need higher dose of Vitamin D (two to three times higher). Likewise, the optimum scheme of administration (daily vs monthly) was never evaluated.
Given new physiopathological data on pleiotropic role of vitamin D (on bone, cardiovascular system, adipose tissue) and in light of consequence of obesity on these systems, it seems essential to obtain data on vitamin deficit correction in obese children and adolescents and to evaluate bone status of these patients using modern imaging technics (high resolution peripheral quantitative computed tomography, HRpQCT).
In this context, the OBEVIDOS study, randomised multi-centre prospective in 156 obese children and adolescent will allow us for :
- evaluate vitamin D correction effect by two scheme of administration
- establish an inventory of vitamin D status in this population
- Modeling and simulation of vitamin D concentration in obese children and adolescents using a mathematical PBPK model
- study, in a patient sub-group, the impact of vitamin D deficit and of obesity by itself on bone, by analysing bone micro-architecture
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Carine Villanueva, MD
- Número de teléfono: +33 4 27 85 53 28
- Correo electrónico: carine.villanueva@chu-lyon.fr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged between 5 to 18 year-old
- Being obese (BMI >97th percentile for age and gender using the WHO references)
- Patients (parents) having given their informed consent
- Patient having insurance from the national health system
Exclusion Criteria:
Children will be excluded from the study if:
- They suffer from symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure) or present signs of rickets at the X-ray (osteopenia and cortical thinning of the long bones, stress fractures, and metaphyseal widening and fraying. The earliest rachitic change is a loss of demarcation between the metaphysic and growth plate and loss of the provisional zone of calcification). A 10-point radiographic scoring system will be used to assess the presence and the severity of rickets on the basis of knee and wrist findings.
- They suffer from a chronic disease such as granulomatous conditions, Williams syndrome, or hypothyroidism predisposing to hypocalcaemia or in case of hypercalcaemia, liver/kidney disease, malabsorption diseases.
- They are under treatment of anticonvulsivants/barbiturates or steroids which increase the catabolism of 25(OH)D.
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product.
- Pregnancy.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Previous enrolment into the current study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Monthly bolus arm
|
Bolus therapy (100'000 - 200'000 IU/month depending on age: < or ≥ 9 years old) for 3 months
|
|
Comparador activo: Daily arm
|
Daily substitution (3'500 to 6'500 IU/day depending on age: < or ≥ 9 years old) for 3 months
|
|
Otro: Control group
Group of obese patients without vitamin D deficiency
|
no cholecalciferol therapy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Proportion of patients reaching the therapeutic target defined as vitamin D (25(OH)D) serum level ≥ 50 nmol/L and < 120 nmol/L
Periodo de tiempo: Month 4
|
Month 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
calcium dosages
Periodo de tiempo: Month 4
|
blood safety dosages
|
Month 4
|
|
phosphore dosages
Periodo de tiempo: Month 4
|
blood safety dosages
|
Month 4
|
|
urinary calcium
Periodo de tiempo: Month 4
|
urinary safety dosages
|
Month 4
|
|
creatinin
Periodo de tiempo: Month 4
|
urinary safety dosages
|
Month 4
|
|
Treatment compliance
Periodo de tiempo: Month 4
|
Month 4
|
|
|
Evaluation of influence of type of skin on study results
Periodo de tiempo: Month 4
|
assessed by Fitzpatrick scale
|
Month 4
|
|
Evaluation of influence of sun exposure on study results
Periodo de tiempo: Month 4
|
assessed by a questionnaire
|
Month 4
|
|
Evaluation of influence of physical activity on study results
Periodo de tiempo: Month 4
|
assessed by a questionnaire
|
Month 4
|
|
Evaluation of influence of alimentary intakes on study results
Periodo de tiempo: Month 4
|
assessed by questionnaires
|
Month 4
|
|
Modeling of vitamin D concentration
Periodo de tiempo: Month 4
|
Modeling and simulation of vitamin D concentration in obese children and adolescents using a mathematical PBPK model
|
Month 4
|
|
Evaluation of one mineral density by biphotonic absorptiometry in the spine
Periodo de tiempo: Day 1
|
Comparison of the both treated arms with the control group
|
Day 1
|
|
Evaluation of one mineral density by biphotonic absorptiometry in the femoral neck
Periodo de tiempo: Day 1
|
Comparison of the both treated arms with the control group
|
Day 1
|
|
Evaluation of bone micro-architecture (HRpQCT) at the radius
Periodo de tiempo: Day 1
|
Comparison of the both treated arms with the control group
|
Day 1
|
|
Evaluation of bone micro-architecture (HRpQCT) at the tibia
Periodo de tiempo: Day 1
|
Comparison of the both treated arms with the control group
|
Day 1
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Carine Villanueva, Hospices Civils De Lyon
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 69HCL18_0148
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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