NCT06067477

Brief Summary

The aim of this study is to perform a double-blind, randomised, dose-response trial of vitamin D3 supplementation in United Kingdom (UK)-dwelling adults of white European, South Asian, and black African/Caribbean ethnicity to investigate the distribution of dietary intakes needed to maintain adequate vitamin D status in winter, as indicated by serum 25(OH)D concentrations at ranges of \>25 to 50 nmol/L. In addition, this study will investigate the effect of vitamin D3 supplementation on immune health, muscular strength, and overall health.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

September 20, 2023

Last Update Submit

May 7, 2024

Conditions

Vitamin D DeficiencyImmune HealthMuscle Function

Outcome Measures

Primary Outcomes (1)

  • Concentration of serum 25(OH)D (nmol/L)

    A blood sample will be analysed using liquid chromatography tandem mass spectroscopy (LC-MS). Dose-response change in serum 25(OH)D will be measured in nmol/L.

    Baseline and 12 weeks

Secondary Outcomes (21)

  • Anthropometric measurements - weight (kg)

    Baseline and 12 weeks

  • Anthropometric measurements - height (m)

    Baseline and 12 weeks

  • Anthropometric measurements - height (cm)

    Baseline and 12 weeks

  • Anthropometric measurements - waist circumference (cm)

    Baseline and 12 weeks

  • Anthropometric measurements - hip circumference (cm)

    Baseline and 12 weeks

  • +16 more secondary outcomes

Study Arms (3)

Vitamin D Supplement 400 IU

ACTIVE COMPARATOR

400 IU (10 µg) of Vitamin D3

Dietary Supplement: Vitamin D Supplement

Vitamin D Supplement 1000 IU

ACTIVE COMPARATOR

1000 IU (25 µg) of Vitamin D3

Dietary Supplement: Vitamin D Supplement

Vitamin D Supplement 2000 IU

ACTIVE COMPARATOR

2000 IU (50 µg) of Vitamin D3

Dietary Supplement: Vitamin D Supplement

Interventions

Vitamin D SupplementDIETARY_SUPPLEMENT

Vitamin D Supplement

Vitamin D Supplement 1000 IUVitamin D Supplement 2000 IUVitamin D Supplement 400 IU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • British white European, black African/Caribbean, or South Asian (self-reported)
  • Living in England for \>2 months
  • Aged \>18 years
  • No significant health issues
  • English or Urdu speaker

You may not qualify if:

  • Medical condition or history which might impact study measurements (e.g., ischaemic heart disease, type 1 and type 2 diabetes, thyroid disease, osteoporosis, haematological disease, malignancy)
  • Medications known to affect vitamin D metabolism (i.e., hormone replacement therapy, anti-oestrogens treatment, antiepileptic drugs, and breast cancer treatment)
  • Pregnant or planning pregnancy during the study period
  • Regular use of sun beds
  • Having a sun holiday one month prior to commencing study or plans for a sun holiday within the study period. A sun holiday is generally defined as a holiday in a sunny resort outside of the UK. The researchers will assess this on a case-by-case basis depending on the time of year and expected weather conditions
  • Reported participation in another clinical trial occurring simultaneously
  • Previous intolerance or allergic reaction to vitamin D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health and Medical Sciences

Guildford, GU2 7XH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Abigail Bournot

    University of Surrey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Bournot, PhD

CONTACT

01483689222a.bournot@surrey.ac.uk

Susan Lanham-New

CONTACT

01483686476s.lanham-new@surrey.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Recruited participants will be randomised to take 400,1000, or 2000 IU for 12 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2023

First Posted

October 5, 2023

Study Start

November 1, 2023

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)