Micronutrient LevelsVITASCOPENCT06882421
VITAmin and Micronutrient Testing: Acceptability and SCOPE of Point-of-care Device
An observational study of Micronutrient Levels, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Micronutrient Levels
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jun 2024to 27 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: 30 children and their parents/carers, attending the Complications of Excess weight (CEW)/ Health Futures Clinic at the Jenny Lind Children's Hospital, NNUH. Parents can participate in the study independently of their children.
Who may be able to join
- Patient aged>10 years or parents of a patient being seen in a NNUH CEW clinic.
- Parents/Participants must have capacity to consent/assent and provide a signed and dated informed consent
- Able to participate in an interview regarding the acceptability/usability of the device.
Who cannot join
- Potential participants will not be eligible if they lack capacity to provide informed consent (or in the case of young people under the age of 16, informed assent and informed parental consent)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
About this study
Official title: Evaluation of the Acceptability and Usability of a Point-of-care-in-vitro Diagnostic Micro-sampling Device for Micronutrient Measurement.
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.
Read the detailed description
Malnutrition, where there is an insufficient supply or inability to absorb nutrients is classified by the World Health Organisation as the biggest worldwide threat to public health. Untreated malnutrition is an independent risk factor for mortality and is associated with increased healthcare costs. Malnutrition is not only found in association with low weight but is also found in individuals with morbid obesity. Obese individuals experience a state of paradoxical malnutrition; despite excessive dietary intake they have high micronutrient deficiencies rates due to intake of energy-dense, nutrient-poor diets. Childhood obesity is a global health crisis with 1.2 million children in England severely obese, putting them at multiple health risks which lower lifespan and affect health.
Currently micronutrient measurement is performed in hospitals. A large volume (>6mls) is taken with results for some tests taking a minimum of 2 weeks. This delays treatment starting and requires provision of additional clinical time for the results to be fed back to patients and their families. There are significant financial, emotional and carbon costs for patients attending for hospital based blood tests.
A point-of-care blood test for micronutrients has been developed, which uses an integrated finger-prick and minimal amount of blood (40μls). The device is simple to use, with just one push of a button, allowing primary care clinicians and potentially parents/guardians to administer the test.
This study aims to ask young people and their parents/carers for their views on this device before further development is undertaken on the product to ensure it meets with their needs.
- Conditions
- Micronutrient Levels
- Keywords
- micronutrient testing acceptability, Point-of-care device
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants and their parents who prefer using a finger prick test for micronutrient measurement.
- What are the preferences of young people and their families regarding the new technology?
- To identify the problems and any benefits of the new technology from patients/parents/guardians/ medical staff
Measured: 12 months
Secondary outcomes (1)
Demographics of study participants
- Age, gender and ethnicity of participants
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start25 Jun 2024
- Primary completion31 Jul 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Micronutrient LevelsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia
- Responsible party
- Sponsor
- Investigators
- Emma Webb, PhD, Principal investigator, Consultant at NNUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882421
- Sponsor's protocol ID
- Version 1.2 03/06/20
- Other IDs
- 62431
- Acronym
- VITASCOPE
- Status last verified
- Aug 2024
- First submitted
- 25 Feb 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acceptability and Usability of a Point-of-care-in-vitro Diagnostic Micro-sampling Device for Micronutrient Measurement.
- ClinicalTrials.gov ID
- NCT06882421
- Acronym / sponsor ID
- VITASCOPE / Version 1.2 03/06/20
- Conditions
- Micronutrient Levels
- Keywords
- micronutrient testing acceptability, Point-of-care device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of East Anglia
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Malnutrition, where there is an insufficient supply or inability to absorb nutrients is classified by the World Health Organisation as the biggest worldwide threat to public health. Untreated malnutrition is an independent risk factor for mortality and is associated with increased healthcare costs. Malnutrition is not only found in association with low weight but is also found in individuals with morbid obesity. Obese individuals experience a state of paradoxical malnutrition; despite excessive dietary intake they have high micronutrient deficiencies rates due to intake of energy-dense, nutrient-poor diets. Childhood obesity is a global health crisis with 1.2 million children in England severely obese, putting them at multiple health risks which lower lifespan and affect health.
Currently micronutrient measurement is performed in hospitals. A large volume (>6mls) is taken with results for some tests taking a minimum of 2 weeks. This delays treatment starting and requires provision of additional clinical time for the results to be fed back to patients and their families. There are significant financial, emotional and carbon costs for patients attending for hospital based blood tests.
A point-of-care blood test for micronutrients has been developed, which uses an integrated finger-prick and minimal amount of blood (40μls). The device is simple to use, with just one push of a button, allowing primary care clinicians and potentially parents/guardians to administer the test.
This study aims to ask young people and their parents/carers for their views on this device before further development is undertaken on the product to ensure it meets with their needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 30 children and their parents/carers, attending the Complications of Excess weight (CEW)/ Health Futures Clinic at the Jenny Lind Children's Hospital, NNUH. Parents can participate in the study independently of their children.
Key inclusion criteria (3 listed)
- Patient aged>10 years or parents of a patient being seen in a NNUH CEW clinic.
- Parents/Participants must have capacity to consent/assent and provide a signed and dated informed consent
- Able to participate in an interview regarding the acceptability/usability of the device.
Key exclusion criteria (1 listed)
- Potential participants will not be eligible if they lack capacity to provide informed consent (or in the case of young people under the age of 16, informed assent and informed parental consent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants and their parents who prefer using a finger prick test for micronutrient measurement.
Time frame: 12 months
1. What are the preferences of young people and their families regarding the new technology? 2. To identify the problems and any benefits of the new technology from patients/parents/guardians/ medical staff
1 secondary outcome
Demographics of study participants
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Micronutrient Levels
Not yet recruiting
Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants
Premature, Preterm Infant Health
Not yet recruiting
MMS, IFA, and MMS+IFA Supplementation in Pregnant Women
Maternal Anemia, Micronutrient Deficiency
Enrolling by invitation
Multivitamin Impact on Micronutrient Status in GLP-1 Users: A Randomized Trial
Weight Loss, Nutritional Deficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Webb, PhD principal investigator
Consultant at NNUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Micronutrient Levels, run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants and their parents who prefer using a finger prick test for micronutrient measurement. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.