OBEVIDOS Treatment of vitamin D deficit in obese children and adolescents: an open label randomized controlled study comparing the efficacy of two oral supplementation regimens: monthly boluses versus daily doses for correcting blood vitamin D level.”

Phase 1

Recruiting

• Conditions: Obese children and adolescents; MedDRA version: 20.0Level: PTClassification code: 10029883Term: Obesity Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-507089-18-00
• Lead Sponsor: Hospices Civils De Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

age = 5 years and < 18 years, Obesity defined by BMI >97th percentile (>IOTF 30) for age and gender using WHO references, Assent of the patients and written consent of both parents/legal guardians, Patient affiliated to the national health system or benefiting from it

Exclusion Criteria

Symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure), Pregnancy, breastfeeding, Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, Vitamin D supplementation in the 3 months preceding the inclusion visit (V1), Simultaneous enrolment to another study which could influence the results of the current study, Ongoing treatment with thiazides diuretics which reduce urinary excretion of calcium, Patient under legal protection or deprived of liberty, 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, Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified