Vitamin D DeficiencyDVinCHINCT05018988
Vitamin D in School Children
A study testing Oral vitamin D spray in people with Vitamin D Deficiency and Musculoskeletal Diseases, run by University of Ulster at 1 site in United Kingdom.
Trial summary
The primary purpose of this study it to investigate total circulating 25-hydroxyvitamin D (25(OH)D) in school children (aged 4-11years) in Northern Ireland; thereby establishing the prevalence of vitamin D status (deficiency, insufficiency, and sufficiency (SACN 2016)) in this cohort. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Musculoskeletal Diseases, Cognitive Delay, Mild
- What is being tested?
- Oral vitamin D spray
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2019to 30 Oct 2025
- Phase
- Interventional
- 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 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 4-11 years attending school in Northern Ireland.
Who cannot join
- Any children on long-term prescription medication; and/or diagnosed with a long-term or exacerbated health condition or disease (does not exclude children with minor or mild health conditions).
- Those previously taking a vitamin D supplement and those not willing to abstain from starting vitamin D supplements.
- Those using home sun beds.
- Those who are planning a family holiday to a sunny country (latitudes below 37°N) during the duration of the intervention.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Human Intervention Studies Unit, Ulster University
Coleraine, Londonderry, BT52 1SA
Ruth Price, +442870123878, rk.price@ulster.ac.uk
Julie Sittlington, +442870124101, jj.sittlington@ulster.ac.uk
About this study
Official title: The D-VinCHI Study: 25-hydroxyvitamin D Concentration in School Children: Effects of Vitamin D3 Supplementation on 25-OH-D Concentration and Muscle Health Outcomes
The primary purpose of this study it to investigate total circulating 25-hydroxyvitamin D (25(OH)D) in school children (aged 4-11years) in Northern Ireland; thereby establishing the prevalence of vitamin D status (deficiency, insufficiency, and sufficiency (SACN 2016)) in this cohort. Additionally, the study aims to determine if 10µg/day vitamin D3 supplementation over 12 weeks maintains vitamin D status.
This area of research is lacking in the quality of prospective studies. While previous literature has focused on the prevalence of vitamin D status in adults, there is a paucity of data available for children. This study will add to the existing knowledge and provide more specific analysis for children.
Hypothesis 1: Increase in vitamin D concentrations will be associated with an improvement in health outcomes including anthropometric measurements, musculoskeletal outcomes, markers of inflammation, nutritional status and bone turnover, lipid profiles, cognitive function, and handgrip strength.
Read the detailed description
The main objectives of this study are to determine prevalence of vitamin D status in 4-11-year-old children and to investigate if 10µg/day maintains vitamin D status in this population. This study will focus on children aged 4-11 years old residing in Northern Ireland. This 2-phase study will incorporate an observational phase and intervention phase to determine prevalence and status, respectively. The expected time under study will be 12 weeks and the number of visits will be limited to two per participant. Where participants are from the same home, randomisation to the same treatment group will occur. Results will be controlled for season.
Vitamin D deficiency is prevalent across the global population including those who reside above 37° North. In addition to a lack of rich dietary sources of vitamin D, residing at this latitude restricts exposure to sunlight due to the zenith angle of the sun. Although vitamin D deficiency is rife in the general population there are certain categories who are at additional risk of vitamin D deficiency including pregnant women, elderly, and institutionalized populations. One population group where there is still a paucity of studies, and a lack of clear guidelines are children. Recent evidence suggests that vitamin D has potential to provide extra skeletal health benefits.
Assessments to be undertaken in this study include anthropometric, handgrip, balance, cognitive function. These assessments will be followed by a 20ml blood draw completed by a trained researcher who is trained in phlebotomy. Additionally, parents will be asked to complete a validated vitamin D food frequency questionnaire and four-day weighed diet diary for their offspring. This study will determine if the recommended supplementation regimen results in the intervention population reporting a sufficient vitamin D status. Blood samples will be analysed for 25(OH)D, serum parathyroid hormone (PTH), serum C-reactive protein (CRP), serum HbA1c (glycated haemoglobin), markers of bone turnover, markers of inflammation, full blood count, lipid profile, and markers of nutritional status. Circulating 25(OH)D will be assessed via liquid chromatography- mass spectrometry (HPLC \& MS).
Sample size was calculated using G*Power software available at QMU (G*Power) by entering the planned statistical analysis method (i.e. t-test or ANOVA), desired effect size (0.5), and experimental design (i.e. two groups with two outcomes). Phase one (observational study) with an effect size of 0.15 requires a total population of 200. Phase two (intervention study) with an effect size of 0.15 requires a total population of 118 (59 in each arm) including a dropout rate of 20%. A total population of 55 is required for Food frequency validation including a 10% dropout rate and for the vitamin D knowledge questionnaire with an effect size of 0.8 a total population of 70 is required.
The planned statistical analysis will be conducted in IBM SPSS and with intention to treat. Results from phase one will be analysed using descriptive statistics. A regression model will be used to determine prediction models for circulating 25(OH)D and the reported secondary outcomes.
- Being tested
- Oral vitamin D spray, Placebo
- Keywords
- Vitamin D, Deficiency, vitamin D3, supplementation, Cholecalciferol, school children, paediatric, 25(OH)D, hypovitaminosis D, postural balance, cognitive function
- Medical subject headings
- Vitamin D Deficiency, Musculoskeletal Diseases, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral vitamin D sprayDietary supplement
Also called vitamin D3
1 spray (10µg) /day for 12 weeks
PlaceboDietary supplement
Also called Xylitol
1 spray / day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Oral vitamin D3 spray | Experimental | 10µg/day for 12 weeks (BetterYou ltd.) Receives: Dietary Supplement: Oral vitamin D spray |
| Placebo Comparator | Placebo comparator | Xylitol (BetterYou ltd.) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma 25-hydroxy vitamin D concentration
Measured by LC/MS
Measured: Change over 12 weeks
Secondary outcomes (4)
Muscle strength
Hand grip strength by a dynamometer
Measured: Change over 12 weeks
Postural balance
Assessed using single leg stance (SLS)
Measured: Change over 12 weeks
Postural balance
Assessed using tandem stance (TS)
Measured: Change over 12 weeks
Cognitive function
Assessed using three CANTAB batteries
Measured: Change over 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Nov 2019
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Observational study followed double blinded randomised control trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Margaret University, Nutrition and Biological Sciences, Musselburgh, Scotland, UK, Better You ltd., Unit 24 Shortwood Court, Shortwood Business Park, Dearne Valley Parkway, Barnsley, S74 9LH, Registered Company No: 05541287
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018988
- Sponsor's protocol ID
- DVinCHI_UU2019
- Acronym
- DVinCHI
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Royle E, Glatt DU, McSorley EM, Pourshahidi K, Armstrong DJ, Grimley L, Slevin MM, Henry CO, McMullan JE, Iniesta RR, McCluskey JT, Gleeson N, Magee PJ. The Effect of Vitamin D3 Supplementation on Vitamin D Status and Associated Health Outcomes in Children: A Randomized Controlled Trial. J Nutr. 2026 Aug;156(8):101493. doi: 10.1016/j.tjnut.2026.101493. Epub 2026 Mar 24.
PubMed 41887286
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The D-VinCHI Study: 25-hydroxyvitamin D Concentration in School Children: Effects of Vitamin D3 Supplementation on 25-OH-D Concentration and Muscle Health Outcomes
- ClinicalTrials.gov ID
- NCT05018988
- Acronym / sponsor ID
- DVinCHI / DVinCHI_UU2019
- Keywords
- Vitamin D, Deficiency, vitamin D3, supplementation, Cholecalciferol, school children, paediatric, 25(OH)D
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Queen Margaret University, Nutrition and Biological Sciences, Musselburgh, Scotland, UK, Better You ltd., Unit 24 Shortwood Court, Shortwood Business Park, Dearne Valley Parkway, Barnsley, S74 9LH, Registered Company No: 05541287
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 24 Aug 2021 (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.
The primary purpose of this study it to investigate total circulating 25-hydroxyvitamin D (25(OH)D) in school children (aged 4-11years) in Northern Ireland; thereby establishing the prevalence of vitamin D status (deficiency, insufficiency, and sufficiency (SACN 2016)) in this cohort. Additionally, the study aims to determine if 10µg/day vitamin D3 supplementation over 12 weeks maintains vitamin D status.
This area of research is lacking in the quality of prospective studies. While previous literature has focused on the prevalence of vitamin D status in adults, there is a paucity of data available for children. This study will add to the existing knowledge and provide more specific analysis for children.
Hypothesis 1: Increase in vitamin D concentrations will be associated with an improvement in health outcomes including anthropometric measurements, musculoskeletal outcomes, markers of inflammation, nutritional status and bone turnover, lipid profiles, cognitive function, and handgrip strength.
Detailed description
The main objectives of this study are to determine prevalence of vitamin D status in 4-11-year-old children and to investigate if 10µg/day maintains vitamin D status in this population. This study will focus on children aged 4-11 years old residing in Northern Ireland. This 2-phase study will incorporate an observational phase and intervention phase to determine prevalence and status, respectively. The expected time under study will be 12 weeks and the number of visits will be limited to two per participant. Where participants are from the same home, randomisation to the same treatment group will occur. Results will be controlled for season.
Vitamin D deficiency is prevalent across the global population including those who reside above 37° North. In addition to a lack of rich dietary sources of vitamin D, residing at this latitude restricts exposure to sunlight due to the zenith angle of the sun. Although vitamin D deficiency is rife in the general population there are certain categories who are at additional risk of vitamin D deficiency including pregnant women, elderly, and institutionalized populations. One population group where there is still a paucity of studies, and a lack of clear guidelines are children. Recent evidence suggests that vitamin D has potential to provide extra skeletal health benefits.
Assessments to be undertaken in this study include anthropometric, handgrip, balance, cognitive function. These assessments will be followed by a 20ml blood draw completed by a trained researcher who is trained in phlebotomy. Additionally, parents will be asked to complete a validated vitamin D food frequency questionnaire and four-day weighed diet diary for their offspring. This study will determine if the recommended supplementation regimen results in the intervention population reporting a sufficient vitamin D status. Blood samples will be analysed for 25(OH)D, serum parathyroid hormone (PTH), serum C-reactive protein (CRP), serum HbA1c (glycated haemoglobin), markers of bone turnover, markers of inflammation, full blood count, lipid profile, and markers of nutritional status. Circulating 25(OH)D will be assessed via liquid chromatography- mass spectrometry (HPLC \& MS).
Sample size was calculated using G*Power software available at QMU (G*Power) by entering the planned statistical analysis method (i.e. t-test or ANOVA), desired effect size (0.5), and experimental design (i.e. two groups with two outcomes). Phase one (observational study) with an effect size of 0.15 requires a total population of 200. Phase two (intervention study) with an effect size of 0.15 requires a total population of 118 (59 in each arm) including a dropout rate of 20%. A total population of 55 is required for Food frequency validation including a 10% dropout rate and for the vitamin D knowledge questionnaire with an effect size of 0.8 a total population of 70 is required.
The planned statistical analysis will be conducted in IBM SPSS and with intention to treat. Results from phase one will be analysed using descriptive statistics. A regression model will be used to determine prediction models for circulating 25(OH)D and the reported secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Observational study followed double blinded randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Oral vitamin D3 spray | Experimental | Dietary Supplement: Oral vitamin D spray10µg/day for 12 weeks (BetterYou ltd.) |
| Placebo Comparator | Placebo comparator | Dietary Supplement: PlaceboXylitol (BetterYou ltd.) |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children aged 4-11 years attending school in Northern Ireland.
Key exclusion criteria (4 listed)
- Any children on long-term prescription medication; and/or diagnosed with a long-term or exacerbated health condition or disease (does not exclude children with minor or mild health conditions).
- Those previously taking a vitamin D supplement and those not willing to abstain from starting vitamin D supplements.
- Those using home sun beds.
- Those who are planning a family holiday to a sunny country (latitudes below 37°N) during the duration of the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral vitamin D sprayAlso: vitamin D31 spray (10µg) /day for 12 weeks | Dietary supplement | Oral vitamin D3 spray |
| PlaceboAlso: Xylitol1 spray / day for 12 weeks | Dietary supplement | Placebo Comparator |
Primary outcome
Plasma 25-hydroxy vitamin D concentration
Time frame: Change over 12 weeks
Measured by LC/MS
4 secondary outcomes
Muscle strength
Time frame: Change over 12 weeks
Postural balance
Time frame: Change over 12 weeks
Postural balance
Time frame: Change over 12 weeks
Cognitive function
Time frame: Change over 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 41887286Royle E, Glatt DU, McSorley EM, Pourshahidi K, Armstrong DJ, Grimley L, Slevin MM, Henry CO, McMullan JE, Iniesta RR, McCluskey JT, Gleeson N, Magee PJ. The Effect of Vitamin D3 Supplementation on Vitamin D Status and Associated Health Outcomes in Children: A Randomized Controlled Trial. J Nutr. 2026 Aug;156(8):101493. doi: 10.1016/j.tjnut.2026.101493. Epub 2026 Mar 24.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral vitamin D spray in people with Vitamin D Deficiency and Musculoskeletal Diseases, run by University of Ulster 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pamela J Magee (+44 28 7012 4360, pj.magee@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma 25-hydroxy vitamin D concentration (time frame: Change over 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018988, which also lists 1 linked publication.
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 24 Aug 2021.