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Vitamin D in School Children

NCT05018988 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2021-08-24

No results posted yet for this study

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.

Conditions

  • Vitamin D Deficiency
  • Musculoskeletal Diseases
  • Cognitive Delay, Mild

Interventions

DIETARY_SUPPLEMENT

Oral vitamin D spray

1 spray (10µg) /day for 12 weeks

DIETARY_SUPPLEMENT

Placebo

1 spray / day for 12 weeks

Sponsors & Collaborators

  • Queen Margaret University, Nutrition and Biological Sciences, Musselburgh, Scotland, UK

    collaborator UNKNOWN

  • Better You ltd., Unit 24 Shortwood Court, Shortwood Business Park, Dearne Valley Parkway, Barnsley, S74 9LH, Registered Company No: 05541287

    collaborator UNKNOWN

  • University of Ulster

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2025-10-30
Completion
2025-10-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05018988 on ClinicalTrials.gov