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Clinical Trials/NCT01832623
NCT01832623
Completed
Not Applicable

Are Bone, Nutritional and Cardiovascular Status of French Children and Adolescents, Correlated With Their Vitamin D Status?

Hospices Civils de Lyon1 site in 1 country100 target enrollmentFebruary 1, 2013
ConditionsVitamin D

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vitamin D
Sponsor
Hospices Civils de Lyon
Enrollment
100
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2013
End Date
July 1, 2016
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

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).

Secondary Outcomes

  • 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).)
  • To study the correlation between vitamin D plasma concentration and nutritional and pubertal status, cardiovascular status, inflammatory status .(up to 3 months)

Study Sites (1)

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