Vitamin D Intervention in Young Adults With Severe Childhood-onset Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- change in S-25OHD
研究概览
简要总结
Obesity is associated with lower total serum 25-hydroxycholecalciferol (S-25OHD) concentration. However, the impact of obesity on free S-25OHD is inadequately studied. A direct assay for free 25OHD was introduced recently.
The aim of the study was to evaluate differences in vitamin D metabolism between young adults with severe childhood-onset obesity and normal-weight controls. Half of the obese subjects and controls will receive placebo and the other half will receive vitamin D3 50 µg daily for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •weight-for-height ratio exceeding 60% before the age of 7 years, according to Finnish growth standards and persistence of severe obesity for at least three years in childhood
- •referral to the Children's Hospital, Helsinki University Hospital due to severe obesity
- •at the age of 7 years lived in the greater Helsinki area
排除标准
- •endocrine or genetic disorders underlying obesity (e.g. Prader Willi syndrome, pseudohypoparathyroidism, hypothyroidism, hypercortisolism, diabetes
结局指标
主要结局
change in S-25OHD
时间窗: baseline, 6 and 12 weeks
change in total and free S-25OHD concentrations between obese and controls
baseline S-25OHD
时间窗: baseline
differences in total and free S-25OHD between obese and controls
次要结局
- baseline vitamin D-binding protein (DBP)(baseline)
- correlation between S-25OHD and calcium, phosphate, parathyroid hormone (PTH) and osteocalcin(baseline, 6 and 12 weeks)
- change in vitamin D-binding protein (DBP)(baseline, 6 and 12 weeks)
研究者
Elisa Holmlund-Suila
MD
Helsinki University Central Hospital