Investigating Vitamin D Levels 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
This study is testing if giving daily vitamin D supplements to school children aged 4-11 in Northern Ireland can improve their health and help with vitamin D deficiency.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 4 Years to 11 Years |
| Sex | All |
| Sponsor | University of Ulster Academic / other |
| Locations | 1 site (Coleraine, Londonderry) |
| Trial ID | NCT05018988 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the prevalence of vitamin D deficiency among school children aged 4-11 years in Northern Ireland and to evaluate the effectiveness of a daily supplementation of 10µg of vitamin D3 over a 12-week period. It will involve an observational phase to determine baseline vitamin D status followed by an intervention phase to monitor changes in health outcomes related to vitamin D levels. Participants will undergo assessments including blood draws, anthropometric measurements, and cognitive function tests to gather comprehensive data on the impact of vitamin D supplementation.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy school children aged 4-11 years residing in Northern Ireland.
Not a fit: Children on long-term prescription medication or with significant health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes in children by addressing vitamin D deficiency and its associated health risks.
How similar studies have performed: While there is limited research specifically on children, previous studies in adults have shown positive outcomes with vitamin D supplementation, suggesting potential for success in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Coleraine, Londonderry
- Human Intervention Studies Unit, Ulster University — Coleraine, Londonderry, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Pamela J Magee
- Email: pj.magee@ulster.ac.uk
- Phone: +44 28 7012 4360
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.