Vitamin D in School Children

NCT05018988 | Unknown

• 1 other identifier: DVinCHI_UU2019
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vitamin D; Deficiency; vitamin D3; supplementation; Cholecalciferol; school children; paediatric; 25(OH)D; hypovitaminosis D; postural balance; cognitive function

Outcome Measures

Primary Outcomes (1)

• Plasma 25-hydroxy vitamin D concentration

  Measured by LC/MS

  Change over 12 weeks

Secondary Outcomes (4)

• Muscle strength

  Change over 12 weeks

• Postural balance

  Change over 12 weeks

• Postural balance

  Change over 12 weeks

• Cognitive function

  Change over 12 weeks

Study Arms (2)

Oral vitamin D3 spray

EXPERIMENTAL

10µg/day for 12 weeks (BetterYou ltd.)

Dietary Supplement: Oral vitamin D spray

Placebo Comparator

PLACEBO COMPARATOR

Xylitol (BetterYou ltd.)

Dietary Supplement: Placebo

Interventions

Oral vitamin D spray DIETARY_SUPPLEMENT

1 spray (10µg) /day for 12 weeks

Also known as: vitamin D3

Oral vitamin D3 spray

Placebo DIETARY_SUPPLEMENT

1 spray / day for 12 weeks

Also known as: Xylitol

Placebo Comparator

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ulster: lead
• Queen Margaret University, Nutrition and Biological Sciences, Musselburgh, Scotland, UK: collaborator
• Better You ltd., Unit 24 Shortwood Court, Shortwood Business Park, Dearne Valley Parkway, Barnsley, S74 9LH, Registered Company No: 05541287: collaborator

Study Sites (1)

Human Intervention Studies Unit, Ulster University

Coleraine, Londonderry, BT52 1SA, United Kingdom

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency; Musculoskeletal Diseases; Lymphoma, Follicular

Interventions

Cholecalciferol; Xylitol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Central Study Contacts

Pamela J Magee

CONTACT

+44 28 7012 4360; pj.magee@ulster.ac.uk

Emeir McSorley

CONTACT

+4402870123543; em.mcsorley@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded to participant and researcher
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Observational study followed double blinded randomised control trial

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: November 1, 2019
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

GB (1)