Comparing monthly and daily vitamin D doses for obese children and adolescents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of monthly boluses versus daily doses of cholecalciferol (vitamin D) in correcting vitamin D deficiency in obese children and adolescents aged 5 to 18. Given the rising prevalence of obesity and its associated health risks, including cardiovascular diseases and type 2 diabetes, this study aims to determine the best supplementation strategy for improving vitamin D levels in this vulnerable population. Participants will be randomly assigned to receive either monthly or daily doses of vitamin D, with their health monitored throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre d'Investigation Clinique de LYON - CIC 1407- Groupement Hospitalier Est / Hospices Civils de Lyon
  Bron, France Recruiting
• Service d'endocrinologie et métabolisme pédiatrique, Hôpital Femme Mère Enfant
  Bron, France Recruiting
• Service d'Endocrinologie Pédiatrique CHU de Clermont-Ferrand
  Clermont-Ferrand, France Not yet recruiting
• Centre Médical Infantile de Romagnat
  Romagnat, France Not yet recruiting

Study contacts

• Principal investigator: Carine Villanueva — Hospices Civils de Lyon
• Study coordinator: Carine Villanueva, MD
• Email: carine.villanueva@chu-lyon.fr
• Phone: 4 27 85 53 28

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.