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

This study is currently recruiting participants.
Verified September 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01832623
First received: April 5, 2013
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Vitamin D
Other: Exploration of Vitamin D roles

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Are Bone, Nutritional and Cardiovascular Status of French Children and Adolescents, Correlated With Their Vitamin D Status?

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Values and standard deviation of 25-OH vitamin D3 plasma concentration concentration in the population studied. [ Time Frame: Once. At inclusion (V1). ] [ Designated as safety issue: No ]
    Blood intake.

  • To study the correlation between vitamin D plasma concentration and nutritional and pubertal status, cardiovascular status, inflammatory status . [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

    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.


  • 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). [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Exploration of Vitamin D roles
  • Visit 1: questioning, physical examination, blood sampling (including plasma collection for future genetic analyses), carotid ultrasound
  • Visit 2 (same day as visit 1 or maxi 3 months later): HR-pQCT, dual energy x-ray absorptiometry (DXA), iontophoresis of acetylcholine and sodium nitroprusside

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01832623

Contacts
Contact: Justine BACHETTA, MD justine.bacchetta@chu-lyon.fr
Contact: Tiphanie GINHOUX (0)427 857 723 ext +33 tiphanie.ginhoux@chu-lyon.fr

Locations
France
Hôpital Femme Mère Enfant Recruiting
Lyon, France, 69003
Contact: Justine BACCHETTA, MD       justine.bacchetta@chu-lyon.fr   
Contact: Tiphanie GINHOUX    (0)427 857 723 ext +33    tiphanie.ginhoux@chu-lyon.fr   
Principal Investigator: Justine BACCHETTA, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Justine Bachetta, MD Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant - 69500 BRON - FRANCE
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01832623     History of Changes
Other Study ID Numbers: 2011.688
Study First Received: April 5, 2013
Last Updated: September 4, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hospices Civils de Lyon:
Vitamin D
bone
cardiovascular status
nutritional status

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 23, 2014