Clinical trial NCT01832623: Vitamin D, Bones, Nutritional and Cardiovascular Status
Official title: Are Bone, Nutritional and Cardiovascular Status of French Children and Adolescents, Correlated With Their Vitamin D Status?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D
Keywords: Vitamin D
bone
cardiovascular status
nutritional status
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 10 year-old \<or= Age \< 18 year-old
* Without mobility handicap (medical walker, crutch, wheelchair...)
* Written informed consent (signed by parents)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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.
timeFrame: up to 3 months
Secondary outcomes:
measure: Values and standard deviation of 25-OH vitamin D3 plasma concentration concentration in the population studied.
timeFrame: Once. At inclusion (V1).
measure: To study the correlation between vitamin D plasma concentration and nutritional and pubertal status, cardiovascular status, inflammatory status .
timeFrame: up to 3 months
measure: 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).
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
affiliation: Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant - 69500 BRON - FRANCE
name: Justine Bachetta, MD
role: PRINCIPAL_INVESTIGATOR
References: