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临床试验/NCT01553344
NCT01553344已完成不适用

Serum Sclerostin Level in Patients With Vitamin D Deficiency

Bagcilar Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Serum sclerostin level

研究概览

简要总结

The aim of this study is to determine serum sclerostin levels and change in serum sclerostin levels in patients with Vitamin D deficiency treated with calcium and vitamin D.

Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with calcium and vitamin D will be included in the study. This is an observational study. The serum sclerostin levels will be measured before and after Vitamin D treatment.

详细描述

This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board.

This study will be completed with patients with Vitamin D deficiency. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained before and after treatment.

Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of serum will be added to eppendorf tubes and stored at -20°C.

Serum sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the manufacturer's instructions. The minimum detectable concentration of human sclerostin is typically <0.012 ng/ml. Intra-assay precision is less than 8%.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Premenopausal
  • Serum 25(OH)D < 10 ng/mL

排除标准

  • Tumor-induced osteomalacia (hypophosphatemia)
  • Hypothyroidism
  • Hepatic / renal disease
  • Primary hyperparathyroidism
  • Fibromyalgia
  • Polymyalgia rheumatica
  • Serum 25(OH)D > 10 ng/mL
  • Vitamin D and calcium treatment commenced prior to study participation

结局指标

主要结局

Serum sclerostin level

时间窗: 8 weeks

Changes in serum sclerostin level in patients with osteomalacia who are scheduled for routine treatment of osteomalacia

次要结局

未报告次要终点

研究者

发起方
Bagcilar Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ilhan Karacan, Clinical Associated Professor

Chief of Physical Med & Rehab Clinic

Bagcilar Training and Research Hospital

研究点 (1)

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