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

Launched by HOSPICES CIVILS DE LYON · Apr 24, 2018

Keywords

ClinConnect Summary

The OBEVIDOS study is a clinical trial that aims to understand the best way to correct vitamin D deficiency in obese children and teenagers. This is important because many obese children have low levels of vitamin D, which can lead to serious health problems like bone issues and diabetes. The study will compare two different methods of giving vitamin D: a monthly high dose versus a daily lower dose. Researchers will also look at how vitamin D levels change in these children and examine the impact of obesity on their bone health.

To participate in this study, children aged 5 to 18 who are considered obese (meaning their body mass index is above the 97th percentile for their age and gender) can join, as long as they have approval from their parents and are covered by national health insurance. Participants will receive vitamin D supplements and will be monitored throughout the trial. It's important to know that children with certain health conditions or those who have recently taken vitamin D supplements might not be eligible for this study. Overall, the goal is to find the best way to help improve vitamin D levels in obese children, which could lead to better health outcomes for them in the future.

Gender

ALL

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 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.