VITASCOPE

  • Research type

    Research Study

  • Full title

    Evaluation of the acceptability and usability of a point-of-care in-vitro diagnostic micro-sampling device for micronutrient measurement (VITASCOPE: VITAmin and micronutrient testing: Acceptability and SCOPE of Point-of-care device)

  • IRAS ID

    343702

  • Contact name

    Emma webb

  • Contact email

    emma.webb@nnuh.nhs.uk

  • Sponsor organisation

    Norfolk and Norwich University Hospitals NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT06882421

  • Duration of Study in the UK

    0 years, 7 months, 1 days

  • Research summary

    Childhood obesity is a global health crisis with 1.2 million children in England severely obese, predisposing them to multiple health risks which decrease lifespan and compromise health. Children suffering from obesity experience a state of paradoxical malnutrition; despite excessive calorie intake they have high rates of micronutrient deficiencies rates due to consumption of energy dense, nutrient poor diets. Around 70-80% of obese children are Vitamin D deficient, 10% have low B12 concentrations and 50% have folic acid deficiency.
    Currently screening for micronutrient deficiencies does not form a routine part of clinical care at all medical centres because they require a large volume of blood and are expensive to perform. We have developed a prototype point-of-care in-vitro diagnostic test which allows at-home/primary care testing of micronutrient levels, using an integrated finger-prick and minimal amount of blood. This device should be simple to use, with just one push of a button. The results are analysed using a phone app for clear decision-making, with data uploaded to healthcare providers automatically.

    This study aims to ask service users (young people and their families) for their views on the usability and acceptability of the device prior to developing the product further.

  • REC name

    HSC REC A

  • REC reference

    24/NI/0064

  • Date of REC Opinion

    12 Jun 2024

  • REC opinion

    Further Information Favourable Opinion