Supplemental Vitamin D and Functional Outcomes in Early Adolescence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 6
- 主要终点
- PTH
研究概览
简要总结
While a large percentage of children have low blood vitamin D levels, the significance of these low levels and the impact on health is unclear. The purpose of this project is to determine the effects of varying doses of vitamin D supplementation over 12 weeks on blood indicators of health in white and black children, aged 9 to 13 years, from both the northern and southern US.
详细描述
Vitamin D intakes in children do not meet current US Dietary Reference Intake recommendations and emerging evidence suggests that a significant number of children, particularly those with darker skin pigmentation, have inadequate levels of serum 25-hydroxyvitamin D [25(OH)D]. The optimum level of circulating 25(OH)D has not been clearly defined in children, nor is it known what functional outcome measures are ideal for defining this level, or if these requirements would differ by race. Graded doses of vitamin D3 supplementation will be used in this dual-site, 12-week trial. The investigators hypothesize that a dose-response relationship will be observed between vitamin D supplementation and intermediate endpoints of skeletal health, and that race will modify these responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-Hispanic
- •Male, 10-13 years of age or female 9-11 years of age
- •Within genitalia or breast stage 2/3
- •Willing to provide blood/urine samples
- •Free from taking vitamin, mineral or herbal supplements
- •Able to swallow tablets
排除标准
- •Menarche (females)
- •Known bone diseases or disease known to influence bone metabolism (e.g. cerebral palsy, intestinal malabsorption, juvenile rheumatoid arthritis)
- •Known growth disorder
- •The use of medications that influence bone metabolism (e.g. corticosteroids, Attention Deficit Hyperactivity Disorder (ADHD) medications).
结局指标
主要结局
PTH
时间窗: 12 weeks
1,25(OH)2D
时间窗: 12 weeks
fractional calcium absorption
时间窗: 12 weeks
biochemical markers of bone turnover
时间窗: 12 weeks
serum 25(OH)D
时间窗: 12 weeks
次要结局
- serum and urinary calcium(12 weeks)
- physical activity data(12 weeks)
- body composition(12 weeks)
- sunlight exposure(12 weeks)
- dietary data(12 weeks)
研究者
Dr. Richard D. Lewis
Professor
University of Georgia