Effects of Milk Protein and Vitamin D on Children's Growth and Health (D-pro)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Bone Mineral Density (BMD)
研究概览
简要总结
The purpose of D-pro is to investigate the combined and separate effects of milk protein and vitamin D on bone health, growth, muscle function, body composition and cardiometabolic health in 6-8-year-old children.
详细描述
The D-pro study investigates the effects of high or medium intakes of milk protein, and vitamin D supplements or placebo, in healthy 6-8 year-old Danish children. The study is a 2×2-factorial randomized controlled trial with 4 study arms. The subjects will be randomly allocated to receive yoghurt products with either high or medium protein content (300g/day, 6 days/week) and to receive tablets with either vitamin D (20 μg/day) or placebo for 24 weeks. Measurements and biological sampling will be performed at baseline and at the end of the intervention.
The primary outcome will be bone mineral density (BMD). The investigators will also measure effects on children's muscle function, cardiometabolic health, body composition, growth and growth factors, nutrient status, immune defence and risk of acute respiratory tract infections, as well as appetite hormones. The investigators will also assess potential sex-specific effects and the potential modifying effect of genotype.
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)
盲法说明
D-pro will be double-blinded in respect to D vitamin supplementation or placebo, whereas the allocation of yoghurt with high versus medium milk protein content will not be blinded.
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children must:
- •Be 6-8 years of age at the start of the intervention
- •Be healthy
- •Have a frequent intake of milk and yoghurt products, corresponding to at least ¼ liter a day
- •Like yoghurt and high protein yoghurt ("skyr")
- •Be of white, Danish or European origin
- •The family must not be planning a winter vacation south of a latitude of 50° North
- •The child must speak and understand Danish in order to understand the study procedures
- •At least one parent must read, speak and write Danish
排除标准
- •Known or suspected allergy or intolerance to milk or milk components
- •Chronic illness or disease that may affect study outcomes
- •Chronic intake of medicine that may affect study outcomes
- •Use of vitamin D-containing supplements >3 days/week the 2 last months and use of any vitamin D-containing supplements the last 1 month before intervention start
- •Concomitant participation in other studies involving dietary supplements or blood sampling
- •Living in a household with another participating child
结局指标
主要结局
Bone Mineral Density (BMD)
时间窗: 24 weeks
Measured by dual energy x-ray absorptiometry (DXA)
次要结局
- Waist circumference(24 weeks)
- Insulin-like Growth Factor 1 (IGF-1)(24 weeks)
- Fat free mass index(24 weeks)
- Bone Mineral Content (BMC)(24 weeks)
- Insulin-like growth factor-binding protein 3 (IGFBP-3)(24 weeks)
- Parathyroid hormone (PTH)(24 weeks)
- Blood pressure(24 weeks)
- Height(24 weeks)
- Serum calcium(24 weeks)
- Osteocalcin(24 weeks)
- Bone-specific alkaline phosphatase(24 weeks)
- Muscle endurance(24 weeks)
- Insulin(24 weeks)
- Fat mass index(24 weeks)
- Bone area(24 weeks)
- C-terminal telopeptide of type 1 collagen in serum (s-CTX)(24 weeks)
- Maximal jumping height(24 weeks)
- Maximal jumping length(24 weeks)
- Glucose(24 weeks)
- High density lipoprotein cholesterol (HDL cholesterol)(24 weeks)
- Low density lipoprotein cholesterol (LDL cholesterol)(24 weeks)
- Maximal leg press strength(24 weeks)
- Hemoglobin A1c (HbA1c)(24 weeks)
- Total cholesterol(24 weeks)
- Maximal grip strength(24 weeks)
- Triacylglycerol (TG)(24 weeks)
研究者
Camilla Trab Damsgaard
Associate Professor
University of Copenhagen