Hôpital Femme Mère Enfant
Lyon, 69003, France
NCT Number: NCT01832623
Vitamin D is not seen anymore only as a phosphocalcic hormone, but also as having an effect on global health (anti-infective, anti-inflammatory, anti-tumour roles and cardiovascular protection).
The link between vitamin D deficiency and osteomalacia lesions is well-known. In paediatrics, systematic vitamin D supplementation of infants and toddlers, associated with milk enrichment, has allowed an almost total disappearance of rickets. Vitamin D repletion was defined as the minimal concentration that enables the prevention of rickets in children and osteomalacia in adults, that is approximately 8 ng/mL (20 nmol/L). However, in 2010, most of the international experts agreed to set minimal threshold of 25 OH vitamin D serum concentration, higher than the one previously admitted, with a limit of 20 ng/mL (50 nmol/L) to define a vitamin D deficiency and a limit of 30 ng/mL (75 nmol/L) to define vitamin D insufficiency in adults. In the paediatric population, the consensus is less obvious and we consider that a serum concentration of minimum 20 ng/mL is necessary.
A study on more than 200 children from Lyon, followed in the paediatric nephrology unit and having a renal function normal or sub-normal, demonstrated an important prevalence of vitamin D deficiency (75%) in adolescents and pre-adolescents.
Concurrently, the appearance of new bone imaging techniques (especially high-resolution peripheral quantitative computed tomography HR-pQCT) improved bone status evaluation in a non-invasive manner.
Given the new pathophysiological data on pleiotropic role of vitamin D (bone, cardiovascular system, adipose tissue) and given the proportion of French children possibly suffering from vitamin D deficiency, it seems urgent to actualize current recommendations regarding systematic supplementation in vitamin D. This transversal study on 200 healthy children and adolescents will allow to have an overview of vitamin D status in French healthy children and adolescents, studying with non-invasive, safe, reliable and innovative tools, the theoretical targets of vitamin D (bones, cardiovascular system and nutritional status); and then to lay the foundations of therapeutic trials aiming to evaluate the mode of vitamin D supplementation for healthy children and adolescents; while having a cohort for HR-pQCT measurements, that will allow us to have French reference range in a 10-17 year-old population, for this innovative, non-invasive and low radiation exposure technique.
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Notify Me10 year–17 year
All sexes
Interventional
Not applicable
Lyon, 69003, France
To study the correlation between bone assessment by high-resolution peripheral quantitative computed tomography (HR-pQCT) and vitamin D serum concentration.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 3 months
The HR-pQCT evaluates bones down to the level of the tiny individual elements that nature configures in a way that makes bones as strong as possible. HR-pQCT measures bone density and quantifies the three dimensional geometry, strength and microarchitecture of bone at the lower arm (radius) and lower leg (tibia).
Time frame: Once. At inclusion (V1).
Blood intake.
Time frame: up to 3 months
Nutritional and pubertal status will be assessed thanks to: Body Mass Index, Dual-energy X-ray Absorptiometry, adipokines level. Cardiovascular status will be assessed thanks to arterial pressure, Intima-media Thickness (IMT), Extra-media Thickness (EMT), lipid profile, endothelial function. IMT and EMT will be obtained using carotid ultrasound. Endothelial function will be evaluated following a protocol of iontophoresis of acetylcholine and sodium nitroprusside.
Inflammatory status will be measured looking at C-reactive protein plasma level.
Time frame: up to 3 months
Hospices Civils de Lyon
Other
Are Bone, Nutritional and Cardiovascular Status of French Children and Adolescents, Correlated With Their Vitamin D Status?
Acronym: VITADOS
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