Are Bone, Nutritional and Cardiovascular Status of French Children and Adolescents, Correlated With Their Vitamin D Status?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
To study the correlation between bone assessment by high-resolution peripheral quantitative computed tomography (HR-pQCT) and vitamin D serum concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10 year-old <or= Age < 18 year-old
- •Without mobility handicap (medical walker, crutch, wheelchair...)
- •Written informed consent (signed by parents)
排除标准
- •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
- •Serious intercurrent disease (infection, neoplasia)
- •Ongoing pregnancy
- •Patient unaffiliated with the French universal healthcare system.
结局指标
主要结局
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.
时间窗: 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).
次要结局
- 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)