跳至主要内容
临床试验/CTRI/2020/03/024109
CTRI/2020/03/024109尚未招募不适用

A Study to Determine the Patient and Disease Profile and Treatment Paradigm in Adult Patients Diagnosed with Vitamin D Deficiency/Insufficiency

Abbott India Ltd5 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年3月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
5
主要终点
1.To understand the patient profile in terms of demographic and anthropometric measurements, exposure to sunlight, lifestyle pattern, and socioeconomic status

研究概览

简要总结

This is a study to determine patient and disease profile in adult patients with Vitamin D deficiency.The study will enroll approximately 200 patients with vitamin D deficiency/insufficiency in approximately 10 sites. Clinical signs and symptoms, physical examinations at baseline and weeks 4 and 8 will be summarized using descriptive statistics.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Male or female patients aged ≥ 18 years
  • Patients newly diagnosed with vitamin D deficiency or insufficiency of known or unknown origin.
  • Patients who are willing to provide written patient authorization
  • Patients with stable anti-hypertension treatment for last 2 months.
  • In case of Hypertension sub-group only.
  • Patients with stable anti-diabetes treatment for last 2 months.
  • In case of Diabetes subgroup only.

排除标准

  • Patients already on treatment for vitamin D deficiency/insufficiency
  • Female patients who are pregnant
  • Patients with a serum level of 25(OH)D > 30 ng/mL 4.

结局指标

主要结局

1.To understand the patient profile in terms of demographic and anthropometric measurements, exposure to sunlight, lifestyle pattern, and socioeconomic status

时间窗: Week 4 and 8

2.To determine the clinical characteristics in terms of clinical signs and symptoms at baseline and weeks 4 and 8

时间窗: Week 4 and 8

次要结局

  • 1.Type and number of comorbidities at baseline.(2.Proportion of patients who are prescribed with vitamin D supplements, including its formulation (as tablets/capsules, injections, or granules in sachets), dose, route, frequency, and duration at weeks 4 and 8)

研究者

申办方类型
Pharmaceutical industry-Indian

研究点 (5)

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