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Comparing Vitamin D Results and Acceptability of Sampling Obtained From Dried Blood Spot, Tasso+ Capillary Sampling, and Venous Blood. (VitD TASSO)

2026年8月19日 更新者：The Royal Wolverhampton Hospitals NHS Trust

Evaluation of a Capillary Self-sampling Device for Vitamin D Testing

This study will evaluate the performance and acceptability of different sampling methods for measuring vitamin D, specifically 25-hydroxyvitamin D₂ and 25-hydroxyvitamin D₃.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This study will evaluate the performance and acceptability of different sampling methods for measuring vitamin D, specifically 25-hydroxyvitamin D₂ and 25-hydroxyvitamin D₃. It will compare results obtained from the routine self-collected dried blood spot (DBS) cards currently in use in our laboratory, with paired capillary and venous serum samples. This compares the collection using three approaches: finger-prick DBS, venepuncture, and the CE-marked Tasso+ upper-arm self-sampling device. The study aims to assess both quantitative agreement between sample types and user acceptability of each collection method.

研究类型

介入性

注册 (估计的)

35

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Current healthcare staff or staff volunteers.
  • Already consented to use the routine dried blood spot (DBS) vitamin D service.
  • Able and willing to provide all three sample types- routine DBS finger-prick sample, a Tasso+ upper-arm self-collected capillary sample, and a venous blood sample taken by a trained Trust phlebotomist.
  • Able to give informed consent.
  • Able to complete a short questionnaire in English.

Exclusion Criteria:

  • • Participants will not be able to take part if any of the following apply:

    • Under 18 years of age
    • Not a member of staff or staff volunteer
    • Known difficulty with blood sampling, such as a history of fainting, severe needle phobia, or conditions that make venepuncture unsafe.
    • Skin conditions or injuries on the upper arm that would prevent safe use of the Tasso+ device.
    • Bleeding disorders or current use of anticoagulant medication that would make capillary or venous sampling unsafe.
    • Inability to give informed consent, including difficulty understanding the study information.
    • Inability to complete the short questionnaire in English, as this is needed to assess user experience.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Vitamin D sampling
Staff members having Vit D sampling using blood spot, venous samples, and sample collected using the device
设备：Vit D Tasso+
Blood collected using Tasso device

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Agreement between Tasso+ capillary serum and venous serum 25(OH)D
大体时间：From Study start date for up to 12 months
Continuous 25(OH)D₂ and 25(OH)D₃ concentrations (nmol/L)
From Study start date for up to 12 months

次要结果测量

结果测量
措施说明
大体时间
User acceptability
大体时间：From Study start date for up to 12 months

Pain, on a scale from 1-5

1= no pain. 5= worse pain
From Study start date for up to 12 months
User acceptability
大体时间：From study start date to 12 months

Ease of Use: how easy or difficult each method was to complete

1= Very difficult, 5=Very easy

Dried Bloodspot Venepuncture Tasso+
From study start date to 12 months
User acceptability
大体时间：From Study start date for up to 12 months

Clarity of Instructions: how clear were the instructions you were given?

1= Not clear at all, 5=Extremely clear

Dried Bloodspot Venepuncture Tasso+
From Study start date for up to 12 months
User acceptability
大体时间：From Study start date for up to 12 months

Safety: How safe did each method feel to you ?

1= Very unsafe, 5=Very safe

Dried Bloodspot Venepuncture Tasso+
From Study start date for up to 12 months
User acceptability
大体时间：From Study start date for up to 12 months

Your Preference: please rank the three collection methods

1= your favourite, 3=least preferred

Dried Bloodspot Venepuncture Tasso+
From Study start date for up to 12 months
User acceptability
大体时间：From Study start date for up to 12 months

Willingness to self-collect: how willing would you be to collect your own sample using each method in the future?

1= Very willing, 5=Very willing

Dried Bloodspot Venepuncture Tasso+
From Study start date for up to 12 months
Sample quality
大体时间：From Study start date for up to 12 months
Volume adequacy- minimum blood vol 200uL
From Study start date for up to 12 months
Sample quality
大体时间：From Study start date for up to 12 months
Pre analytical failure- % samples unacceptable for analysis due to inadequate volume or poor quality blood spot
From Study start date for up to 12 months
Laboratory workflow efficiency
大体时间：From Study start date for up to 12 months
Hands on time (hrs/mins)
From Study start date for up to 12 months
Laboratory workflow efficiency
大体时间：From Study start date for up to 12 months
Batch failures based on LCMSMS batch acceptance criteria- QC with +/- 2sd of mean, cal curve R value > 0.95
From Study start date for up to 12 months
Laboratory workflow efficiency
大体时间：From Study start date for up to 12 months
Repeat samples (%)
From Study start date for up to 12 months
Turnaround time (TAT)
大体时间：From Study start date for up to 12 months
Time from sample request to result authorisation
From Study start date for up to 12 months
Clinical classification agreement
大体时间：From Study start date for up to 12 months
Numerical agreement (statistically quantified by Passing and Bablok analysis)
From Study start date for up to 12 months
Clinical classification agreement
大体时间：From Study start date for up to 12 months
Vitamin D status category agreement (deficient / insufficient / replete) quantified statistically using Cohen's kappa analysis
From Study start date for up to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The Royal Wolverhampton Hospitals NHS Trust

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年7月14日

首先提交符合 QC 标准的

2026年8月19日

首次发布 (实际的)

2026年8月24日

研究记录更新

最后更新发布 (实际的)

2026年8月24日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2026LAB148

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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