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VITAmin and Micronutrient Testing: Acceptability and SCOPE of Point-of-care Device

NCT06882421 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-04-02

No results posted yet for this study

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. A prototype point-of-care in-vitro diagnostic test has been developed 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.

Conditions

  • Micronutrient Levels

Sponsors & Collaborators

  • University of East Anglia

    collaborator OTHER

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Emma Webb, PhD · Consultant at NNUH

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2024-07-31
Completion
2024-09-27

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06882421 on ClinicalTrials.gov