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临床试验/NCT00882505
NCT00882505已完成不适用

Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.

Northwestern University2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Murad Alam

Professor in Dermatology, Otolaryngology- Head and Neck Surgery, and Surgery-Organ Transplantation

Northwestern University

研究点 (2)

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