Actively Recruiting

Phase 3
Age: 5Years - 18Years
All Genders
NCT03516968

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

Age: 5Years - 18Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here