Analysis of Associations Between s-25OHD and Hand Grip Strength at 5 Years in Odense Child Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 881
- 主要终点
- Hand Grip Strength at 5 years
研究概览
简要总结
This study will encompass an analysis of an eventual association between vitamin D status (maternal during pregnancy, at birth or at 5 years) and hand grip strength at 5 years in children from Odense Child Cohort. Odense Child Cohort is a large-scale, prospective, population-based, follow-up study. Mothers and their children born from January 2010 to December 2012 and resident in the Municipality of Odense, Denmark, are followed from early pregnancy up to adulthood. Data is obtained from questionnaires and medical records and venous blood samples were drawn and stored at a biological bank.
Low muscle strength in children has been linked to adiposity, cardiovascular disease and metabolic risk factors and low muscle strength in adolescence has been shown to be a risk factor of early adulthood mortality. There are not many studies on muscle strength in small children. There is some evidence of vitamin D concentrations in the blood having a positive correlation to upper body muscle strength in adolescent girls.
Hypovitaminosis D defined as serum 25-hydroxyvitamin D <50nmol/L was evident in 27,8% of the pregnant women and 47,7% of the new-born children in Odense Child Cohort.
Animal studies have shown an effect of vitamin D on regulation of muscle function and development. Studies on humans adults have shown that vitamin D deficiency can lead to myopathy. Myopathy in children as a result of hypovitaminosis D is not well-studied.
Given the high prevalence of hypovitaminosis D, mild or severe vitamin D-associated myopathy may be prevalent in preschool children.
The objectives of this study are 1) to create reference values and determine predictors of hand grip strength at five years, 2) to analyze the associations between vitamin D at different time points and hand grip strength at 5 years.
详细描述
Background The hand grip test has previously been used to study muscle strength in children (1). The test has also been found to be a reliable alternative in population-based studies to the gold standard isokinetic dynamometry (2).
There is not much research on hand grip strength in preschoolers and no consensus about which variables explain the variance in the normal distribution (3-5).
S-25-hydroxyvitamin D (s-25OHD) <50 nmol/L is prevalent in Denmark particularly in the winter due to the lack of ultraviolet B exposure and insufficient dietary intake (6). Vitamin D deficiency can lead to vitamin D-associated myopathy before developing actual bone disease (7). Little is known about vitamin-D-associated myopathy in children. Given the high prevalence of hypovitaminosis D, vitamin D-associated myopathy may be prevalent in preschool children.
The main objectives of this study were to: 1) establish a normative data-set of hand grip measurements for five-year-old children and determine which variables (during pregnancy, at birth and current) are associated to hand grip strength at five years of age and 2) investigate the association between vitamin-D-status (at 5 years, at birth, in early and in late pregnancy) and hand grip strength at the age of five.
Methods As many 5-year old children from Odense Child Cohort (OCC)as possible will be included during the study period (January 2016-June 2017). Expected number of children investigated by study completion is 1200. The exclusion criteria are multiple birth, preterm birth (GA<259 days), chronic disease and missing hand grip data at five years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 5 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5-year-old children participating in Odense Child Cohort.
排除标准
- •Multiple and/or preterm birth (gestational age (GA) <259 days)
- •Chronic disease
- •No available hand grip data at five years.
结局指标
主要结局
Hand Grip Strength at 5 years
时间窗: Examination within a week of 5 year birthday. 3-5 measurements with a duration of 5 seconds each of each hand.
DHD-1 Digital Hand Dynamometer is used to measure 5-year-old children's hand grip strength. According to standard protocol the child is instructed to hold the dynamometer and the handle is adjusted to the child's hand. The child must be able to press the handle using the whole hand and not just the finger joints. The child must sit with a straight back and feet on the ground. The arm must not be supported by the hip, the elbow must be flexed to 90 degrees and the hand must be in the natural position. The child is instructed to press as hard as possible but in a slow movement to avoid sudden changes in position that might affect the results. Each measurement is approximately 5 seconds long with 1 minute break in between measuring the right and left hand interchangeably. Three measurements of each hand are taken starting with the right hand. If the last measure is the highest, a fourth measurement is taken and a fifth and last measurement is taken if the fourth is the highest.
次要结局
未报告次要终点
研究者
Henrik Christesen
Consultant, Professor, MD, PhD
Odense University Hospital