Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- For the randomized controlled trial, the primary outcome measure is comparison of the change in vitamin D levels in the vitamin D supplementation group and the placebo group.
研究概览
简要总结
The objective of this study is to assess whether vitamin D supplements are sufficient to increase females who are deficient or borderline deficient in vitamin D levels to normal levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 47 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal Caucasian women, ages 18-47
- •Subjects in good health
- •Tanning bed group: regular tanning bed user at least once a week for previous 10 weeks
排除标准
- •Pregnancy and lactation
- •Subjects with liver disease, renal disease, multiple myeloma, parathyroid disease, irritable bowel disease, celiac disease, cystic fibrosis and pancreatic disease
- •Subjects with hypocholesterolemia and primary hyperparathyroidism
- •Subjects taking the following medications:
- •Lipid lowering medication: cholestyramine, statins
- •Antiepileptic drugs: phenobarbital and phenytoin
- •Currently on vitamin D supplements or using any medication contain vitamin D i.e. cod liver oil, topical calcipotriol or history of use within 1 month
- •Rifampicin, isoniazid
- •Ketoconazole
- •Subjects currently on UV therapy
研究组 & 干预措施
Placebo
Receive placebo pills
干预措施: Placebo (Other)
Tanning bed user
Regular tanning bed users will be assessed for their vitamin D levels.
Vitamin D supplement
Receive vitamin D supplements.
干预措施: vitamin D (Dietary Supplement)
结局指标
主要结局
For the randomized controlled trial, the primary outcome measure is comparison of the change in vitamin D levels in the vitamin D supplementation group and the placebo group.
时间窗: 3 months
For the comparative study, the primary outcome measure is comparison of the vitamin D level for tanning bed users compared to the level for non-tanning bed users.
时间窗: 3 months
次要结局
- The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level.(3 months)
研究者
Murad Alam
Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation
Northwestern University