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

Recruiting Phase 3 Interventional Study
Obesity, Childhood
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
5 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
68 (estimated)
Sponsor
Hospices Civils de Lyon · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
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 …
Contacts

Carine Villanueva, MD

4 27 85 53 28

carine.villanueva@chu-lyon.fr

CONTACT