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NCT Number: NCT07782528

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vit D Tasso+

Device

Blood collected using Tasso device

Primary outcomes

  1. Agreement between Tasso+ capillary serum and venous serum 25(OH)D

    Time frame: From Study start date for up to 12 months

    Continuous 25(OH)D₂ and 25(OH)D₃ concentrations (nmol/L)

Secondary outcomes

  1. User acceptability

    Time frame: From Study start date for up to 12 months

    Pain, on a scale from 1-5

    1= no pain. 5= worse pain

  2. User acceptability

    Time frame: 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+

  3. User acceptability

    Time frame: 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+

  4. User acceptability

    Time frame: 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+

  5. User acceptability

    Time frame: 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+

  6. User acceptability

    Time frame: 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+

  7. Sample quality

    Time frame: From Study start date for up to 12 months

    Volume adequacy- minimum blood vol 200uL

  8. Sample quality

    Time frame: 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

  9. Laboratory workflow efficiency

    Time frame: From Study start date for up to 12 months

    Hands on time (hrs/mins)

  10. Laboratory workflow efficiency

    Time frame: 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

  11. Laboratory workflow efficiency

    Time frame: From Study start date for up to 12 months

    Repeat samples (%)

  12. Turnaround time (TAT)

    Time frame: From Study start date for up to 12 months

    Time from sample request to result authorisation

  13. Clinical classification agreement

    Time frame: From Study start date for up to 12 months

    Numerical agreement (statistically quantified by Passing and Bablok analysis)

  14. Clinical classification agreement

    Time frame: From Study start date for up to 12 months

    Vitamin D status category agreement (deficient / insufficient / replete) quantified statistically using Cohen's kappa analysis

Sponsors and collaborators

Lead sponsor

The Royal Wolverhampton Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Acronym: VitD TASSO

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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