Vitamin D, Bones, Nutritional and Cardiovascular Status (VITADOS)

Civil Hospices of Lyon

Status

Completed

Conditions

Vitamin D

Treatments

Other: Exploration of Vitamin D roles

Study type

Interventional

Funder types

Other

Identifiers

NCT01832623

2011.688

Details and patient eligibility

About

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.

Full description

To study the correlation between bone assessment by high-resolution peripheral quantitative computed tomography (HR-pQCT) and vitamin D serum concentration.

Enrollment

100 patients

Sex

All

Ages

10 to 17 years old

Volunteers

Accepts Healthy Volunteers

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.