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.
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. Recruited participants will be randomised to take 400, 1000, or 2000 IU for 12 weeks. Fasting blood samples collected at baseline and 12 weeks will measure biochemical markers of vitamin D status (serum 25(OH)D, calcium, parathyroid hormone, albumin), lipid profile, ferritin, micronutrient status, and immune and inflammatory biomarkers. Muscular strength will be measured using sit-to-stand and grip strength tests. Questionnaires, food diaries, and dosimeters will be used to gather data on lifestyle, physical activity, dietary intake, and sun exposure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
114
Vitamin D Supplement
Faculty of Health and Medical Sciences
Guildford, United Kingdom
RECRUITINGConcentration 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.
Time frame: Baseline and 12 weeks
Anthropometric measurements - weight (kg)
Weight (kg)
Time frame: Baseline and 12 weeks
Anthropometric measurements - height (m)
Height (m)
Time frame: Baseline and 12 weeks
Anthropometric measurements - height (cm)
Height (cm)
Time frame: Baseline and 12 weeks
Anthropometric measurements - waist circumference (cm)
Waist circumference measurement (cm)
Time frame: Baseline and 12 weeks
Anthropometric measurements - hip circumference (cm)
Hip circumference measurement (cm)
Time frame: Baseline and 12 weeks
Concentration of serum calcium (nmol/L)
Measure dose-response change in serum calcium measured in nmol/L
Time frame: Baseline and 12 weeks
Concentration of plasma parathyroid hormone (PTH) (pg/mL)
Measure dose-response change in plasma parathyroid hormone (PTH) measured in pg/mL
Time frame: Baseline and 12 weeks
Concentration of serum albumin (g/L)
Measure dose-response change in serum albumin measured in g/L
Time frame: Baseline and 12 weeks
Concentration of C-Reactive Protein (CRP) (mg/L)
Measure dose-response change in CRP measured in mg/L
Time frame: Baseline and 12 weeks
Complete blood count
Measure change in complete blood count
Time frame: Baseline and 12 weeks
Change in immune parameters
Measure change in gene expression in white blood cells
Time frame: Baseline and 12 weeks
Number of participants with Acute Respiratory Tract Infections (ARTIs)
Measure the frequency of ARTIs using a validated questionnaire
Time frame: 12 weeks
Muscular strength using a handgrip strength test (kg)
Muscular strength measured using a dynamometer (measured to the nearest 0.1kg). The participant will squeeze the dynamometer with maximum effort for 5 seconds.
Time frame: Baseline and 12 weeks
Muscular strength and endurance using a sit-to-stand test
Number of sit to stands in 30 seconds
Time frame: Baseline and 12 weeks
Blood analytes - micronutrient status
Measure dose-response change in micronutrient status from blood samples
Time frame: Baseline and 12 weeks
Blood analytes - lipid profile (mg/dL)
Measure change in lipid profile from blood samples measured in mg/dL
Time frame: Baseline and 12 weeks
Vitamin D consumption from diet
Vitamin D intake will be measured through a 4-day food diary which participants will fill out for 4 day at home before and after the study.
Time frame: Baseline and 12 weeks
Physical activity questionnaire
Assess level of physical activity using an International Physical Activity Questionnaire (short form)
Time frame: Baseline
Sun exposure behaviour questionnaire
Measures amount of time spent in the sun (often, occasionally, never) and what parts of the body are exposed (head, hands, arms, legs, torso) over summer, spring, autumn and winter. Also questions any summer holidays abroad, in what month, what country was visited, number of hours of sun per day and what body parts were exposed (head, hands, arms, legs, torso)
Time frame: Baseline
Ultraviolet B radiation (UVB) sun exposure
Sun exposure will be measured by a dosimeter, which measures UVB exposure. Participants wear this like a badge for 4 days before and after the study.
Time frame: Baseline and 12 weeks
Lifestyle questionnaire
Measures: \- Skin type (Fitzpatrick scale) Questions: Questions what ethnicity they identify with, Holidays abroad, Education, Origin, Health, Pregnancy, Sun behaviours (what body parts are usually exposed to the sun, clothing, sun bathing, sunscreen use, sun bed use), Smoking, Drinking, Recreational drug use, Knowledge around vitamin D, supplement use, Milk, egg, oily fish and liver consumption
Time frame: Baseline
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