跳至主要内容
临床试验/2023-504664-42-02
2023-504664-42-02招募中3 期

REQUIRED DOSE OF CHOLECALCIFEROL IN THE MANAGEMENT OF VITAMIN D DEFICIENCY AND INSUFFICIENCY IN POSTMENOPAUSAL WOMEN

Clinica Palacios Madrid S.L.1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年6月27日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
To evaluate the efficacy of cholecalciferol, serum vitamin D titration will be performed at the initial view, view 3 and final visit.

研究概览

简要总结

Efficacy of the use of Cholecalciferol in postmenopausal women with vitamin D deficiency or insufficiency

入排标准

年龄范围
18 years 至 65+ years(65+ Years, 18-64 Years)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged ≥ 45 years.
  • Menopausal women with more than one year of amenorrhea.
  • Women with deficiency(40pt) of Vit D (25(OH) Vit D < 20 ng/ml), and with insufficiency(40pt) of Vit D (25(OH) Vit D, 20-30 ng/ml).
  • Women who are willing to participate, and who are able to understand the explanation given to them about the nature of the study.
  • Signed written informed consent.

排除标准

  • Patients with chronic decompensated diseases
  • Mental condition that prevents them from consenting to participate in the study.
  • Optimal vitamin D levels
  • Allergy to one of the product's compounds.
  • Concomitant use, or in the last 4 weeks, of other products containing vitamin D.

结局指标

主要结局

To evaluate the efficacy of cholecalciferol, serum vitamin D titration will be performed at the initial view, view 3 and final visit.

To evaluate the efficacy of cholecalciferol, serum vitamin D titration will be performed at the initial view, view 3 and final visit.

次要结局

  • Vitamin D levels will be evaluated in the four groups to see if with 1000 IU normal levels are maintained. The patients' satisfaction with the treatment will be evaluated.

研究者

发起方
Clinica Palacios Madrid S.L.
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Santiago Palacios

Scientific

Clinica Palacios Madrid S.L.

研究点 (1)

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