Do Vitamin D Fortified Cheese and Yogurt Products Support Vitamin D Status and Functional Outcomes in Young Children? Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Vitamin D serum concentration
研究概览
简要总结
This study is being done to test if adding vitamin D to cheese and yogurt products will help children further improve their vitamin D intake. All children will be given a six month supply of the milk products. One group will receive yogurt and cheese products already sold in stores, while the other group will receive yogurt and cheese products with added vitamin D. This will show if milk products with added vitamin D help maintain vitamin D intake and child health.
The investigators are asking children 2 through 8 years old to participate. Children must not have any medical conditions that affect their bones or vitamin D levels. They must not be taking vitamin D supplements or medications that affect bone. This study will last for 6 months. The investigators expect 60 children from the Montreal area will participate in this study.
Children will be randomly placed in one of the two study groups. There will be an equal number of children in each group. All groups will go through the exact same procedures during the study; the only difference between groups will be the amount of vitamin D in the milk products they will consume each day. Families will not know which group their child is in until the study is complete. Children will continue to drink their regular milk at home and the investigators will provide flavoured yogurts and cheese to eat every day for the entire 6 month study. Families will be given a fresh supply of the yogurt or cheese products every 4 weeks along with instructions.
There are 3 study meetings for the parent and child to attend which take place at the Mary Emily Clinical Nutrition Research Unit. The clinic is located on the Macdonald Campus of McGill University in Ste. Anne-de-Bellevue, QC. The first visit is at the start of the study, the second is at the end of 3 months and the last visit is at the end of the 6 month study.
详细描述
Primary Objective:
- Establish how much vitamin D intake from food is required to maintain vitamin D status consistent with 75 nmol/L of serum 25(OH)D in all children from the beginning of the UVB-void period (beginning of October) to the end of the winter period (end of April). The amount of vitamin D will be selected based on Phase 1 data (January to April 2014).
It is hypothesized that total intakes half of the EAR of 400 IU (i.e. 200 IU/d as a typical intake by young children) will result in exceeding a serum 25(OH)D of 40 nmol/L as the population target that aligns with the current EAR value. Intakes reaching the RDA of 600 IU will support serum concentrations of 25(OH)D over 50 nmol/L (and enable further investigations regarding functional outcomes in bone such as BMC and BMD).
Secondary Objectives: 2. Demonstrate that children with higher vitamin D status (≥ 50 nmol/L 25(OH)D) will have improved biomarkers of bone mineral metabolism compared to those with lower vitamin D status (<50 nmol/L 25(OH)D).
It is hypothesized that children with higher vitamin D status will have lower PTH and CTx with higher P1NP and normal iCa, suggesting that other bone health outcomes would also be improved; in preparation for the follow-up studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children 2 through 8 years of age;
- •Healthy body weight for age.
排除标准
- •Regular use of vitamin D supplements;
- •Lactose intolerant;
- •Don't drink milk or eat cheese or yogurt;
- •Prior treatment for biochemically confirmed vitamin D deficiency;
- •Known or suspected medical conditions associated with bone and vitamin D including rickets, osteomalacia, liver disease, renal disease, immobilization (complete or partial), fractures, and disorders of the parathyroid gland;
- •Known or suspected chronic illness of childhood, such as asthma, cancer, Crohn's disease, nephrotic syndrome, rheumatic conditions, and diabetes, etc;
- •Use in the past 3 months of medications known to affect bone and/or mineral ion metabolism including oral/systemic/inhaled glucocorticoids, phosphate therapy or vitamin D analogues. Bisphosphonates are also included in this category;
- •however, because of their long-half lives and persistence in bone tissue, any prior use of bisphosphonate therapy precludes enrolment;
- •Conditions in which the procurement of 8 ml of blood would compromise the health of the patient (i.e. patients with severe anemia).
结局指标
主要结局
Vitamin D serum concentration
时间窗: 6 month
How much vitamin D intake from food is required to maintain vitamin D status consistent with 50 nmol/L of serum 25(OH)D in all children from the beginning of the UVB-void period (beginning of October) to the end of the winter period (end of April).
次要结局
- Body Composition(6 month)
- Body Compositon(6 month)
- Bone Mineral Density(6 month)
研究者
Hope Weiler
Associate Professor
McGill University