NCT01058720已完成4 期
A Pilot Study to Evaluate the Efficacy of Daily Vitamin D3 Supplementation in Normal Weight Adolescents
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Increment in 25(OH)vitamin D level
研究概览
简要总结
The study is designed to evaluate the increment of serum 25 (OH) vitamin D levels in normal weight adolescents following a 12-week supplementation with Vitamin D3 2000 IU/day.
详细描述
Twenty normal weight adolescents between ages 12-18 that are age and gender would receive vitamin D3 supplementation at a dose of 2000 IU/day. Levels of 25(OH)vitamin D would be measured at baseline and after 12 weeks.Relationship between 25 OH vitamin D levels and other demographic variables will be assessed.The primary endpoint in this study is the 25 OH Vitamin D level at 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects between ages 12 and 18 years with BMI between the 5th and the 85th percentile for age and gender.
排除标准
- •Subjects with 25 (OH)- D levels >80 ng/mL
- •Serum calcium >10.8 mg/dL
- •Serum phosphorus > 5.5 mg/dl
- •Pregnancy or nursing
- •Current cancer
- •Patients on multivitamin supplementation
- •Dietary calcium intake exceeding 1500 mg/day
- •Hepatic or renal disorders
- •Type 1 or Type 2 diabetes mellitus
- •Those receiving insulin, metformin, or oral hypoglycemic medications
- •Malabsorption disorders (Celiac disease, Cystic fibrosis, Inflammatory bowel disease)
研究组 & 干预措施
Vitamin D3
Experimental
Patients would receive 2000 IU of vitamin D3 daily for 12 weeks
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Increment in 25(OH)vitamin D level
时间窗: 12 weeks
次要结局
- Serum Calcium(12 weeks)
研究者
研究点 (1)
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