Vitamin D DeficiencyNCT06067477
Estimation of the Dietary Requirement for Vitamin D in Ethnic Groups
A study testing Vitamin D Supplement in people with Vitamin D Deficiency and Immune Health, run by University of Surrey at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Immune Health, Muscle Function
- What is being tested?
- Vitamin D Supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Faculty of Health and Medical Sciences
Guildford, GU2 7XH
Abigail Bournot, PhD, 01483689222, a.bournot@surrey.ac.uk
Susan Lanham-New, 01483686476, s.lanham-new@surrey.ac.uk
About this study
Official title: Estimation of the Dietary Requirement for Vitamin D in Ethnic Groups: a Double-blind, Randomised, Dose-response Trial
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.
Read the detailed description
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.
- Conditions
- Vitamin D Deficiency, Immune Health, Muscle Function
- Being tested
- Vitamin D Supplement
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D SupplementDietary supplement
Vitamin D Supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Supplement 400 IU | Active comparator | 400 IU (10 µg) of Vitamin D3 Receives: Dietary Supplement: Vitamin D Supplement |
| Vitamin D Supplement 1000 IU | Active comparator | 1000 IU (25 µg) of Vitamin D3 Receives: Dietary Supplement: Vitamin D Supplement |
| Vitamin D Supplement 2000 IU | Active comparator | 2000 IU (50 µg) of Vitamin D3 Receives: Dietary Supplement: Vitamin D Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (21)
Anthropometric measurements - weight (kg)
Weight (kg)
Measured: Baseline and 12 weeks
Anthropometric measurements - height (m)
Height (m)
Measured: Baseline and 12 weeks
Anthropometric measurements - height (cm)
Height (cm)
Measured: Baseline and 12 weeks
Anthropometric measurements - waist circumference (cm)
Waist circumference measurement (cm)
Measured: Baseline and 12 weeks
Anthropometric measurements - hip circumference (cm)
Hip circumference measurement (cm)
Measured: Baseline and 12 weeks
Concentration of serum calcium (nmol/L)
Measure dose-response change in serum calcium measured in nmol/L
Measured: 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
Measured: Baseline and 12 weeks
Concentration of serum albumin (g/L)
Measure dose-response change in serum albumin measured in g/L
Measured: Baseline and 12 weeks
Concentration of C-Reactive Protein (CRP) (mg/L)
Measure dose-response change in CRP measured in mg/L
Measured: Baseline and 12 weeks
Complete blood count
Measure change in complete blood count
Measured: Baseline and 12 weeks
Change in immune parameters
Measure change in gene expression in white blood cells
Measured: Baseline and 12 weeks
Number of participants with Acute Respiratory Tract Infections (ARTIs)
Measure the frequency of ARTIs using a validated questionnaire
Measured: 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.
Measured: Baseline and 12 weeks
Muscular strength and endurance using a sit-to-stand test
Number of sit to stands in 30 seconds
Measured: Baseline and 12 weeks
Blood analytes - micronutrient status
Measure dose-response change in micronutrient status from blood samples
Measured: Baseline and 12 weeks
Blood analytes - lipid profile (mg/dL)
Measure change in lipid profile from blood samples measured in mg/dL
Measured: 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.
Measured: Baseline and 12 weeks
Physical activity questionnaire
Assess level of physical activity using an International Physical Activity Questionnaire (short form)
Measured: 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)
Measured: 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.
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Nov 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Recruited participants will be randomised to take 400,1000, or 2000 IU for 12 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading
- Responsible party
- Sponsor
- Investigators
- Abigail Bournot, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067477
- Sponsor's protocol ID
- FHMS 22-23 194 EGA
- Status last verified
- May 2024
- First submitted
- 20 Sep 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Dietary Requirement for Vitamin D in Ethnic Groups: a Double-blind, Randomised, Dose-response Trial
- ClinicalTrials.gov ID
- NCT06067477
- Acronym / sponsor ID
- FHMS 22-23 194 EGA
- Conditions
- Vitamin D Deficiency, Immune Health, Muscle Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- University of Reading
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Recruited participants will be randomised to take 400,1000, or 2000 IU for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Supplement 400 IU | Active comparator | Dietary Supplement: Vitamin D Supplement400 IU (10 µg) of Vitamin D3 |
| Vitamin D Supplement 1000 IU | Active comparator | Dietary Supplement: Vitamin D Supplement1000 IU (25 µg) of Vitamin D3 |
| Vitamin D Supplement 2000 IU | Active comparator | Dietary Supplement: Vitamin D Supplement2000 IU (50 µg) of Vitamin D3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D SupplementVitamin D Supplement | Dietary supplement | Vitamin D Supplement 1000 IU, Vitamin D Supplement 2000 IU, Vitamin D Supplement 400 IU |
Primary outcome
Concentration of serum 25(OH)D (nmol/L)
Time frame: Baseline and 12 weeks
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.
21 secondary outcomes
Anthropometric measurements - weight (kg)
Time frame: Baseline and 12 weeks
Anthropometric measurements - height (m)
Time frame: Baseline and 12 weeks
Anthropometric measurements - height (cm)
Time frame: Baseline and 12 weeks
Anthropometric measurements - waist circumference (cm)
Time frame: Baseline and 12 weeks
Anthropometric measurements - hip circumference (cm)
Time frame: Baseline and 12 weeks
Concentration of serum calcium (nmol/L)
Time frame: Baseline and 12 weeks
Concentration of plasma parathyroid hormone (PTH) (pg/mL)
Time frame: Baseline and 12 weeks
Concentration of serum albumin (g/L)
Time frame: Baseline and 12 weeks
Concentration of C-Reactive Protein (CRP) (mg/L)
Time frame: Baseline and 12 weeks
Complete blood count
Time frame: Baseline and 12 weeks
Change in immune parameters
Time frame: Baseline and 12 weeks
Number of participants with Acute Respiratory Tract Infections (ARTIs)
Time frame: 12 weeks
Muscular strength using a handgrip strength test (kg)
Time frame: Baseline and 12 weeks
Muscular strength and endurance using a sit-to-stand test
Time frame: Baseline and 12 weeks
Blood analytes - micronutrient status
Time frame: Baseline and 12 weeks
Blood analytes - lipid profile (mg/dL)
Time frame: Baseline and 12 weeks
Vitamin D consumption from diet
Time frame: Baseline and 12 weeks
Physical activity questionnaire
Time frame: Baseline
Sun exposure behaviour questionnaire
Time frame: Baseline
Ultraviolet B radiation (UVB) sun exposure
Time frame: Baseline and 12 weeks
Lifestyle questionnaire
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abigail Bournot principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D Supplement in people with Vitamin D Deficiency and Immune Health, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abigail Bournot, PhD (01483689222, a.bournot@surrey.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of serum 25(OH)D (nmol/L) (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.