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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 11
Healthy Volunteers: t
View:

• Healthy children aged 4-11 years attending school in Northern Ireland.

Locations
Other Locations
United Kingdom
Human Intervention Studies Unit, Ulster University
RECRUITING
Coleraine
Contact Information
Primary
Pamela J Magee
pj.magee@ulster.ac.uk
+44 28 7012 4360
Backup
Emeir McSorley
em.mcsorley@ulster.ac.uk
+4402870123543
Time Frame
Start Date: 2019-11-01
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 118
Treatments
Experimental: Oral vitamin D3 spray
10µg/day for 12 weeks (BetterYou ltd.)
Placebo_comparator: Placebo Comparator
Xylitol (BetterYou ltd.)
Related Therapeutic Areas
Sponsors
Collaborators: Better You ltd., Unit 24 Shortwood Court, Shortwood Business Park, Dearne Valley Parkway, Barnsley, S74 9LH, Registered Company No: 05541287, Queen Margaret University, Nutrition and Biological Sciences, Musselburgh, Scotland, UK
Leads: University of Ulster

This content was sourced from clinicaltrials.gov