Vitamin D in School Children (NCT05018988) | Clinical Trial Compass
UnknownNot Applicable
Vitamin D in School Children
United Kingdom118 participantsStarted 2019-11-01
Plain-language 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. 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.
Who can participate
Age range
4 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.