Actively Recruiting
Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents
Led by Hospices Civils de Lyon · Updated on 2025-06-13
68
Participants Needed
4
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 5 to 18 years old
- Being obese with BMI greater than the 97th percentile or IOTF 30 for age and gender using WHO references
- Patient or parent has given informed consent
- Patient has insurance from the national health system
You will not qualify if you...
- Symptomatic vitamin D deficiency such as tetany, muscular hypotonia, or hypocalcaemic seizure
- Vitamin D supplementation within 3 months before inclusion
- Signs of rickets on X-ray including osteopenia, cortical thinning, stress fractures, metaphyseal widening or fraying
- Chronic diseases like granulomatous conditions, Williams syndrome, hypothyroidism, liver or kidney disease, malabsorption diseases
- Hypercalcaemia (calcium > 2.65 mmol/L) or hypercalciuria (urinary Calcium/Creatinine > 0.7 mmol/mmol)
- Calcium nephrolithiasis, hypervitaminosis D (25-(OH)D > 250 nmol/L), or nephrocalcinosis
- Treatment with anticonvulsants, barbiturates, steroids that increase vitamin D catabolism
- Treatment with thiazide diuretics
- Known hypersensitivity or allergy to study drugs
- Pregnancy or breastfeeding
- Inability to follow study procedures due to language, psychological, or cognitive issues
- Enrollment in another study that could affect results
- Patient under legal protection or deprived of liberty
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Centre d'Investigation Clinique de LYON - CIC 1407- Groupement Hospitalier Est / Hospices Civils de Lyon
Bron, France, 69677
Actively Recruiting
2
Service d'endocrinologie et métabolisme pédiatrique, Hôpital Femme Mère Enfant
Bron, France, 69677
Actively Recruiting
3
Service d'Endocrinologie Pédiatrique CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Not Yet Recruiting
4
Centre Médical Infantile de Romagnat
Romagnat, France, 63540
Not Yet Recruiting
Research Team
C
Carine Villanueva, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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