Vitamin DVitD TASSONCT07782528
Comparing Vitamin D Results and Acceptability of Sampling Obtained From Dried Blood Spot, Tasso+ Capillary Sampling, and Venous Blood.
A study testing Vit D Tasso+ in people with Vitamin D, run by The Royal Wolverhampton Hospitals NHS Trust.
Trial summary
This study will evaluate the performance and acceptability of different sampling methods for measuring vitamin D, specifically 25-hydroxyvitamin D₂ and 25-hydroxyvitamin D₃. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D
- What is being tested?
- Vit D Tasso+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Vitamin D
- Being tested
- Vit D Tasso+
- Keywords
- Vitamin D Tasso
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit D Tasso+Device
Blood collected using Tasso device
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D sampling | Experimental | Staff members having Vit D sampling using blood spot, venous samples, and sample collected using the device Receives: Device: Vit D Tasso+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between Tasso+ capillary serum and venous serum 25(OH)D
Continuous 25(OH)D₂ and 25(OH)D₃ concentrations (nmol/L)
Measured: From Study start date for up to 12 months
Secondary outcomes (14)
User acceptability
Pain, on a scale from 1-5
1= no pain. 5= worse pain
Measured: From Study start date for up to 12 months
User acceptability
Ease of Use: how easy or difficult each method was to complete
1= Very difficult, 5=Very easy
Dried Bloodspot Venepuncture Tasso+
Measured: From study start date to 12 months
User acceptability
Clarity of Instructions: how clear were the instructions you were given?
1= Not clear at all, 5=Extremely clear
Dried Bloodspot Venepuncture Tasso+
Measured: From Study start date for up to 12 months
User acceptability
Safety: How safe did each method feel to you ?
1= Very unsafe, 5=Very safe
Dried Bloodspot Venepuncture Tasso+
Measured: From Study start date for up to 12 months
User acceptability
Your Preference: please rank the three collection methods
1= your favourite, 3=least preferred
Dried Bloodspot Venepuncture Tasso+
Measured: From Study start date for up to 12 months
User acceptability
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+
Measured: From Study start date for up to 12 months
Sample quality
Volume adequacy- minimum blood vol 200uL
Measured: From Study start date for up to 12 months
Sample quality
Pre analytical failure- % samples unacceptable for analysis due to inadequate volume or poor quality blood spot
Measured: From Study start date for up to 12 months
Laboratory workflow efficiency
Hands on time (hrs/mins)
Measured: From Study start date for up to 12 months
Laboratory workflow efficiency
Batch failures based on LCMSMS batch acceptance criteria- QC with +/- 2sd of mean, cal curve R value > 0.95
Measured: From Study start date for up to 12 months
Laboratory workflow efficiency
Repeat samples (%)
Measured: From Study start date for up to 12 months
Turnaround time (TAT)
Time from sample request to result authorisation
Measured: From Study start date for up to 12 months
Clinical classification agreement
Numerical agreement (statistically quantified by Passing and Bablok analysis)
Measured: From Study start date for up to 12 months
Clinical classification agreement
Vitamin D status category agreement (deficient / insufficient / replete) quantified statistically using Cohen's kappa analysis
Measured: From Study start date for up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin DStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782528
- Sponsor's protocol ID
- 2026LAB148
- Acronym
- VitD TASSO
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No