Clinical trial · Interventional
Vitamin D in School Children
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Delay, Mild | — | UNRESOLVED | — |
| Musculoskeletal Diseases | — | UNRESOLVED | — |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral vitamin D spray | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oral vitamin D3 spray
- description
- 10µg/day for 12 weeks (BetterYou ltd.)
- interventionNames
- Dietary Supplement: Oral vitamin D spray
- type
- PLACEBO_COMPARATOR
- label
- Placebo Comparator
- description
- Xylitol (BetterYou ltd.)
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
- Plasma 25-hydroxy vitamin D concentration
- timeFrame
- Change over 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 11 Years
Show eligibility criteria text
Inclusion Criteria: * Healthy children aged 4-11 years attending school in Northern Ireland. Exclusion Criteria: * 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.
References
Publications (1)
- DERIVEDRoyle 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. PMID 41887286