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临床试验/EUCTR2009-011758-16-SE
EUCTR2009-011758-16-SE进行中(未招募)不适用

A randomized placebo controlled trial of vitamin D3 supplementation to a vulnerable patientsgroup susceptible to uppertract respiratory infections.

Karolinska University Hospital Huddinge0 个研究点开始时间: 2009年10月22日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. patients (men and women) aged 18-75with a documented immunodeficiency order IgA IgG or subclass defiency as defined as: hypogammaglobulinemia AND a history of increased airborne infections > 42 days of infections /year
  • 2. patient (men and women) 18-75 years old with an increased frequency of airborne infections i.e. > 42days of infection a year but with none of the above stated deficiencies.
  • 3. patients who accepts to make a daily record of their infections diseasesnuances in a standarized questionnaire form (infections diary)
  • 4. plasma concentrations of 25 (OH) D3 vitamine D3 < 175nM
  • 5. signed informed consent
  • 6. patients must be listed in the immunodefience unit for at least 1 year ahead
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1. patients with less than 42 days of infections a year
  • 2. patients has a ongoing antibiotic treatment
  • 3. patients has clinical signs of hypercalcemia AND/OR verified hypercalcemia by biochemistry of hypercalcemia (>2.5mmol/L)
  • 4. patients has clinical signs of change in parathyroidhormone (PTH >65ng/L) AND/OR verified by biochemistry
  • 5. patients cannot fill in the infection questionnaire
  • 6. patient are not expected to survive more than one year
  • 7. patient has participated in another clinical trial within the last 6 months

研究者

发起方
Karolinska University Hospital Huddinge

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