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: OBEVIDOS

Who is this study for? Children with Obesity
What treatments are being studied? Cholecalciferol
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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 calcium absorption fraction, assessment of bone mineral density and bone mineral content using absorptiometry. Vitamin D deficiency leads to malabsorption of calcium and phosphate in the digestive tract, with concentrations, especially of calcium, tending to fall in plasma, resulting in hypersecretion of PTH, which mobilises bone calcium to maintain subnormal blood calcium levels. Each unit increase in BMI is associated with lower serum vitamin D concentrations: given these low concentrations in this population associated with the risk of developing pathologies, it is important to ensure adequate vitamin D supplementation. The latest paediatric recommendations recommend, for children aged between 1 and 18 with vitamin D deficiency, a supplement of 2,000 IU/day for at least 6 weeks or a bolus of 50,000 IU once a week for at least 6 weeks. There are different dosage regimens for the replacement of vitamin D deficiency depending on the country: there is a lack of data on the appropriate dosage and administration regimens for vitamin D supplementation in cases of deficiency, particularly in obese children and adolescents. A prospective, randomised clinical trial will make it possible to define the vitamin D supplementation regimen best suited to increasing serum vitamin D levels in these children and adolescents suffering from obesity.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre d'Investigation Clinique de LYON - CIC 1407- Groupement Hospitalier Est / Hospices Civils de Lyon
RECRUITING
Bron
Service d'endocrinologie et métabolisme pédiatrique, Hôpital Femme Mère Enfant
RECRUITING
Bron
Service d'Endocrinologie Pédiatrique CHU de Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
Centre Médical Infantile de Romagnat
NOT_YET_RECRUITING
Romagnat
Contact Information
Primary
Carine Villanueva, MD
carine.villanueva@chu-lyon.fr
4 27 85 53 28
Time Frame
Start Date: 2023-12-04
Estimated Completion Date: 2027-03
Participants
Target number of participants: 68
Treatments
Experimental: Monthly bolus arm
Experimental: Daily arm
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov