Comparing Different Amounts of Vitamin D Supplementation to Preschool Children Living in Northern and Southern Sweden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- Serum 25OH-vitamin D levels
研究概览
简要总结
Vitamin D has a range of biological effects of public health relevance. Vitamin D status is assessed on levels of its metabolite 25-hydroxyvitamin D [25(OH)D], where levels < 50 nmol/L indicate insufficiency. Despite studies indicating that the vitamin D intake among Swedish children are significantly below recommendations, little is known of their vitamin D status. The investigators have recently found inadequate vitamin D status in pre-school children living in northern Sweden, especially in dark-skinned children and during the winter months despite vitamin D intakes meeting the recommendations. Overall, 25% of the light skinned and 40% of the dark skinned children had S-25(OH) D <50 nmol/L (Öhlund I, unpublished data). The aim is to examine which amount of vitamin D is needed to maintain or increase S-25(OH)D to ≥50 nmol/L among 97.5% of the participants regardless of skin color or geographic location (northern or southern Sweden). Furthermore the investigators will examine if vitamin D status affects on health markers as bone density, blood pressure, serum lipids, fatty acids, inflammatory and immunological markers and mental wellbeing.
Children aged 5-8 years living either northern (Umeå) or southern Sweden (Malmö) will be recruited to this trial during November-December 2012. They will be randomized to a vitamin D supplement of either 10 or 25 g per day, or in Malmö also placebo to be used for three months. The randomization will be stratified according to skin color (light or dark) according to a method using visual inspection and interviews of parents/guardians. The investigators will use a 2×2×2 factorial design to investigate the effects of two different doses of vitamin D (10 µg and 25 µg) in children with dark and light skin color, living in northern (Umeå) and southern (Malmö), Sweden. In order to achieve a moderate difference between groups (effect size 0.25) 20 children per group are required (power> 87%, alpha = 0.05). With an estimated dropout of 10%, a total of 220 children will be included.
At baseline, the participants will undergo blood sampling for S-25(OH)D and other biomarkers, blood pressure and anthropometrical measurements, including bone densitometry and body composition using air displacement pletysmography, and the parents will answer a questionnaire on behavioral and emotional problems in the participating child using the Child Behavior Checklist. These measurements will be repeated at follow-up in February-March 2013.
详细描述
Vitamin D has a range of biological effects of public health relevance (Prentice et al, 2008). Besides its well known role in mineralization of bone and teeth, vitamin D also play important roles in metabolic functions, the pathogenesis of certain diseases, e.g. type 1 diabetes, celiac disease, asthma and allergies, as well as in the prevention of cancer (Holick, 2008).
Vitamin D status is assessed on plasma or serum levels of its metabolite 25-hydroxyvitamin D [25(OH)D, calcidiol] as it reflects the sum of vitamin D converted in the skin through sunlight exposure and from dietary sources. Several reports advocate that levels <37 nmol/L denote severe vitamin D deficiency; levels <50 nmol/L insufficient; 50-75 nmol/L suboptimal levels and ≥75nmol/L optimal levels (Dawson-Hughes et al, 2005, Huh et al, 2008, Yetley, 2008). In children, most suggested cut-off values for adequate levels of 25(OH)D are based on the absence of rickets, increased measures of bone mineralization and maximal suppression of parathyroid hormone (PTH) levels (Greer, 2009).
The major source of vitamin D is dermal biosynthesis catalyzed by ultraviolet B sunlight (Cashman et al, 2011). However, during winter, northern Sweden has limited hours of daylight leading to reduced sun exposure. Consequently, the dietary source of vitamin D is of specific importance in this region (Brustad et al, 2007, Edvardsen et al, 2007). Fatty fish, eggs, vitamin D fortified milk and margarines are the main sources, mainly supplying the most active form D3. These are important basic foods which also contain common food allergens. Thus, children with food allergies to milk, fish, and egg can be at increased risk of vitamin D deficiency. Several dairy products are fortified with vitamin D, but in some products in the form of D2 which is not as bioactive as D3.
Skin color affects the capacity to form vitamin D3 as children with dark complexion need 5-10 times more sun exposure to generate the same amount of vitamin D3 compared to fair-skinned children, and therefore are at increased risk of vitamin D deficiency when exposure to sun is limited (Holick, 2005). Recently the recommendations on protecting the skin from sunshine to reduce the risk of skin cancer later in life has been debated as it may increase the risk of vitamin D deficiency (Stechschulte et al, 2011). Obesity in children might be another risk factor for vitamin D deficiency, since an increased proportion of available vitamin D may be stored in adipose tissue thus lowering the S-25(OH)D (Prentice, 2008).
Despite studies indicating that the vitamin D intake among Swedish children and adolescents are significantly below recommendations, little is known of their vitamin D status (Garemo et al, 2007, Enghardt et al, 2006, Öhlund et al, 2010). Furthermore there is a paucity of studies investigating vitamin D intake and status in food-allergic adolescents who may be at increased risk of vitamin D insufficiency due to strict avoidance of vitamin D containing foods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •5-7 years of age
排除标准
- •Chronic illness, including coeliac disease or other chronic gastrointestinal disorders
- •Drugs that can affect bone health or vitamin D uptake
- •Cow's milk allergy
结局指标
主要结局
Serum 25OH-vitamin D levels
时间窗: 90 days after start of treatment
次要结局
- Bone mineralisation(120 days after start of treatment)
研究者
Torbjörn Lind
Associate professor
Umeå University
