Vitamin D, Bones, Nutritional and Cardiovascular Status
- Conditions
- Vitamin D
- Interventions
- Other: Exploration of Vitamin D roles
- Registration Number
- NCT01832623
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
To study the correlation between bone assessment by high-resolution peripheral quantitative computed tomography (HR-pQCT) and vitamin D serum concentration.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 10 year-old <or= Age < 18 year-old
- Without mobility handicap (medical walker, crutch, wheelchair...)
- Written informed consent (signed by parents)
-
History of treatment with growth hormone
-
History of treatment with oral corticoids, taken over more than 3 consecutive months
-
Current treatment with growth hormone, corticoids or anti-calcineurin
-
Treatment with aspirin or nonsteroidal anti-inflammatory drug within the last three weeks
-
Treatment with paracetamol within the last week
-
Chronic pathology with an impact on growth:
- Parenteral nutrition
- Chronic inflammatory disease (rheumatologic or digestive notably)
- System diseases (lupus, granulomatosis, vascularitis)
- Renal failure
- Diabetes
-
Serious intercurrent disease (infection, neoplasia)
-
Ongoing pregnancy
-
Patient unaffiliated with the French universal healthcare system.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exploration of Vitamin D roles Exploration of Vitamin D roles Various exams will be performed during two visits (the same day or within three months) in order to answer the objectives of the study.
- Primary Outcome Measures
Name Time Method To study the correlation between the results of bone microarchitecture obtained by high-resolution peripheral quantitative computed tomography (HR-pQCT) and vitamin D serum concentration. 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).
- Secondary Outcome Measures
Name Time Method To evaluate the relation between bone parameters (HR-pQCT) and adipokines; and the relation between bone parameters and cardio-vascular data (blood pressure, IMT, EMT, lipid profile, endothelial function). up to 3 months Values and standard deviation of 25-OH vitamin D3 plasma concentration concentration in the population studied. Once. At inclusion (V1). Blood intake.
To study the correlation between vitamin D plasma concentration and nutritional and pubertal status, cardiovascular status, inflammatory status . 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.
Trial Locations
- Locations (1)
Hôpital Femme Mère Enfant
🇫🇷Lyon, France