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

RecruitingPhase 3Ages 5 Years - 18 YearsAllHospices Civils de Lyon
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In plain words

What the trial is, and whether it could suit you

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 ca

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged between 5 to 18 year-old * Being obese (BMI \>97th percentile, \> IOTF 30, 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: * Symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure) * Vitamin D supplementation in the 3 months preceding the inclusion visit (V1) * Signs of rickets at the X-ray (osteopenia and cortical thinning of the long bones, stress fractures, and metaphyseal widening and fraying) * Chronic disease such as granulomatous conditions, Williams syndrome, or hypothyroidism predisposing to hypocalcaemia or in case of hypercalcaemia (calcium \> 2.65 mmol/L), liver/kidney disease, malabsorption diseases; * Hypercalciuria (urinary Calcium/Creatinine \> 0.7 mmol/mmol), calcium nephrolithiasis, hypervitaminosis D (25-(OH)D \> 250 nmol/L); nephrocalcinosis; * Ongoing treatment with anticonvulsants/barbiturates or steroids which increase the catabolism of 25(OH)D; * Ongoing treatment with thiazides diuretics which reduce urinary excretion of calcium; * Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product; * Pregnancy, breastfeeding; * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant; * Simultaneous enrolment to another study which could influence the results of the current study; * Patient under legal protection or deprived of liberty.
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What it tests

  • Monthly bolus of cholecalciferol per os
  • Daily dose of cholecalciferol per os
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Where

4 sites
Centre d'Investigation Clinique de LYON - CIC 1407- Groupement Hospitalier Est / Hospices Civils de Lyon
Bron, France
Service d'endocrinologie et métabolisme pédiatrique, Hôpital Femme Mère Enfant
Bron, France
Service d'Endocrinologie Pédiatrique CHU de Clermont-Ferrand
Clermont-Ferrand, France
Centre Médical Infantile de Romagnat
Romagnat, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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