NCT01268111已完成1 期
Effect of Vitamin D Supplementation on Insulin Sensitivity and Retinol-binding Protein 4 Levels in Subjects With Vitamin D Deficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- M Value (Insulin Stimulated Glucose Uptake)
研究概览
简要总结
Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before and after the intervention, and the changes will be compared between the two groups. This will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are mediated by RBP4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 years
- •No known medical illnesses requiring pharmacotherapy
- •Not on any mineral or vitamin supplements in the last 3 months
排除标准
- •Subjects requiring prompt initiation of pharmacotherapy, such as those with incidentally discovered diabetes mellitus or hypertension.
- •Previous administration of glucocorticoids, retinoic acid derivatives, or insulin sensitizers in the preceding 3 months.
- •Bariatric surgery or liposuction
- •Unintentional weight loss >5% of the body weight in last 3 months
- •Chronic smokers (> 1 pk/d for 10 years)
- •Alcohol use > 2 drinks/day
研究组 & 干预措施
Vitamin D
Experimental
ERgocalcifoerol 50,000 units q weekly for 8 weeks
干预措施: Ergocalciferols (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
M Value (Insulin Stimulated Glucose Uptake)
时间窗: Baseline and at 8 weeks
Insulin stimulated glucose uptake will be measured by glucose clamp studies
次要结局
未报告次要终点
研究者
研究点 (1)
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