Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents

Obesity, Childhood Clinical Trial

— Obevidos  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03516968
• Other study ID #: 69HCL18_0148
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2023
• Est. completion date: April 2026

Study information

• Verified date: November 2022
• Source: Hospices Civils de Lyon
• Contact: Carine Villanueva, MD
• Phone: 4 27 85 53 28
• Email: carine.villanueva[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Drug:
• Monthly bolus of cholecalciferol per os
Bolus therapy (100'000 - 200'000 IU/month depending on age: < or = 9 years old) for 3 months
• Daily dose of cholecalciferol per os
Daily substitution (3'500 to 6'500 IU/day depending on age: < or = 9 years old) for 3 months

Other:
• Control
no cholecalciferol therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients reaching the therapeutic target defined as vitamin D (25(OH)D) serum level = 50 nmol/L and < 120 nmol/L		Month 4
Secondary	calcium dosages	blood safety dosages	Month 4
Secondary	phosphore dosages	blood safety dosages	Month 4
Secondary	urinary calcium	urinary safety dosages	Month 4
Secondary	creatinin	urinary safety dosages	Month 4
Secondary	Treatment compliance		Month 4
Secondary	Evaluation of influence of type of skin on study results	assessed by Fitzpatrick scale	Month 4
Secondary	Evaluation of influence of sun exposure on study results	assessed by a questionnaire	Month 4
Secondary	Evaluation of influence of physical activity on study results	assessed by a questionnaire	Month 4
Secondary	Evaluation of influence of alimentary intakes on study results	assessed by questionnaires	Month 4
Secondary	Modeling of vitamin D concentration	Modeling and simulation of vitamin D concentration in obese children and adolescents using a mathematical PBPK model	Month 4
Secondary	Evaluation of one mineral density by biphotonic absorptiometry in the spine	Comparison of the both treated arms with the control group	Day 1
Secondary	Evaluation of one mineral density by biphotonic absorptiometry in the femoral neck	Comparison of the both treated arms with the control group	Day 1
Secondary	Evaluation of bone micro-architecture (HRpQCT) at the radius	Comparison of the both treated arms with the control group	Day 1
Secondary	Evaluation of bone micro-architecture (HRpQCT) at the tibia	Comparison of the both treated arms with the control group	Day 1