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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 21, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 21, 2014
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:
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014