Childhood obesity is one of the most serious public health challenges of the 21st century, with an increasing prevalence over time in developed countries. Overweight and obese children and adolescents are likely to remain so into adulthood and to develop chronic diseases at a young age, such as diabetes and cardiovascular disease. Obese patients, whether adults or children, are likely to have low serum vitamin D levels due to sequestration and/or volumetric dilution of this fat-soluble vitamin in adipose tissue. Studies have established a link between vitamin D deficiency or insufficiency and chronic diseases such as hypertension, type 2 diabetes and other metabolic problems. Determining physiological 25(OH)D levels to ensure optimal phosphocalcic metabolism and bone mineralisation requires the use of functional markers: parathyroid hormone (PTH) levels, assessment of the intestinal calcium absorption fraction, assessment of bone mineral density and bone mineral content using absorptiometry. Vitamin D deficiency leads to malabsorption of calcium and phosphate in the digestive tract, with concentrations, especially of calcium, tending to fall in plasma, resulting in hypersecretion of PTH, which mobilises bone calcium to maintain subnormal blood calcium levels. Each unit increase in BMI is associated with lower serum vitamin D concentrations: given these low concentrations in this population associated with the risk of developing pathologies, it is important to ensure adequate vitamin D supplementation. The latest paediatric recommendations recommend, for children aged between 1 and 18 with vitamin D deficiency, a supplement of 2,000 IU/day for at least 6 weeks or a bolus of 50,000 IU once a week for at least 6 weeks. There are different dosage regimens for the replacement of vitamin D deficiency depending on the country: there is a lack of data on the appropriate dosage and administration regimens for vitamin D supplementation in cases of deficiency, particularly in obese children and adolescents. A prospective, randomised clinical trial will make it possible to define the vitamin D supplementation regimen best suited to increasing serum vitamin D levels in these children and adolescents suffering from obesity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Bolus therapy: first 50 000 IU and a second 50 IU after 6 weeks
Daily substitution, 1200 IU per day (4 drops), for 3 months
Centre d'Investigation Clinique de LYON - CIC 1407- Groupement Hospitalier Est / Hospices Civils de Lyon
Bron, France
RECRUITINGService d'endocrinologie et métabolisme pédiatrique, Hôpital Femme Mère Enfant
Bron, France
RECRUITINGService d'Endocrinologie Pédiatrique CHU de Clermont-Ferrand
Clermont-Ferrand, France
NOT_YET_RECRUITINGCentre Médical Infantile de Romagnat
Romagnat, France
NOT_YET_RECRUITINGProportion of patients reaching the therapeutic target defined as vitamin D (25(OH)D) serum level ≥ 50 nmol/L and < 120 nmol/L
Vitamin D (25OH)D) serum level
Time frame: Month 3
calcium dosages
blood safety dosages
Time frame: Month 3
phosphore dosages
blood safety dosages
Time frame: Month 3
vitamin D (25(OH)D) dosages
blood safety dosages
Time frame: Month 3
urinary calcium
urinary safety dosages
Time frame: Month 3
creatinin
urinary safety dosages
Time frame: Month 3
Treatment compliance
amount of treatment taken (Daily arm: patient diary and weighting of returned treatment at M3. Bolus arm: description of taken ampoules after hospital dosing (number taken, empty or not))
Time frame: Month 3
Evaluation of influence of type of skin on study results
assessed a questionnaire
Time frame: Month 3
Evaluation of influence of physical activity on study results
assessed by a questionnaire
Time frame: Month 3
Evaluation of influence of sun exposure on study results
assessed by a questionnaire
Time frame: Month 3
Evaluation of influence of alimentary intakes on study results
assessed by questionnaires
Time frame: Month 3
Bone mineral density description (DXA)
Bone mineral density
Time frame: Day 1
Evaluation of the PTH variation
PTH serum level
Time frame: Month 3
Comparison bone mineral density (DXA) with a preexisting cohort
Bone mineral density (DXA)
Time frame: Day 1
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