Vitamin D DeficiencyNCT05802433
The Genetic Effects on Vitamin D Supplementation
A study testing Vitamin D3 supplement in people with Vitamin D Deficiency, run by St. Mary's University, Twickenham at 1 site in United Kingdom.
Trial summary
Vitamin D is essential for skeletal growth and bone health, deficiency causes rickets and osteomalacia. In the UK 29% of adults have vitamin D deficiency. It is recommended all adults take 10µg vitamin D supplement daily. Genetic variations could alter vitamin D status by affecting vitamin D metabolism. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D3 supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 May 2022to 5 Oct 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- female and male
- 18-65 years
- completion of physical activity readiness questionnaire (PAR-Q).
Who cannot join
- Below 18 years
- above 65 years
- individuals taking medications that could interact with vitamin D status
- Individuals regularly taking daily Vitamin D supplementation during the 3 months before the intervention start date
- major dietary changes in vitamin D intake during the intervention period
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Mary's University Twickenham
London, Lobdon, TW1 4SX
Yiannis Mavrommatis, 020 8240 4000, yiannis.mavrommatis@stmarys.ac.uk
About this study
Official title: Effects of VDR rs7311856, GC rs2282679 and CYP2R1 rs2060793 Variants on Vitamin D Status: A Randomised Control Trial
Vitamin D is essential for skeletal growth and bone health, deficiency causes rickets and osteomalacia. In the UK 29% of adults have vitamin D deficiency. It is recommended all adults take 10µg vitamin D supplement daily. Genetic variations could alter vitamin D status by affecting vitamin D metabolism. Systematic reviews found variations in VDR, GC and CYP2R1 genes are associated with vitamin D deficiency. This study aims to assess the effects between vitamin D supplementation and variations in VDR, GC and CYP2R1 genes on vitamin D status.
Read the detailed description
The study design is a quantitative, randomised control trial measuring vitamin D concentrations in blood serum. All participants will be given the recommended 10µg daily dose of vitamin D supplementation. Participants will be grouped based on their genotype for each gene, as either low, medium or high-risk genotypes. The low-risk group will act as a control and the medium and high-risk groups will act as the intervention groups.
Participants will attend St Mary's University's applied science laboratory twice. During their first visit participants will provide a 2ml capillary blood sample. Blood samples are collected using lancets to prick participants' ear lobes. The serum is extracted from the blood samples, serum is stored at -80c until analysis. Participants will be given 90 10µg vitamin D supplements and instructed to take one per day for 90 days. Participants will also be instructed to not make any major changes to their habitual diet. During the second visit participants will provide 1 ml of saliva sample into the Collection Pot and a second 2ml sample of blood. Serum samples will be analysed for vitamin D concentrations using 25(OH) Vitamin D ELISA kit. DNA will be extracted from the saliva samples using PSP SalivaGene DNA Kit following the manufacturer's protocol. DNA will be genotyped for variations in the VDR, GC and CYP2R1 genes. Data will be assessed to determine if variations in these genes influenced the effectiveness of vitamin D supplementation.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D3 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 D3 supplementDietary supplement
10µg vitamin D3 supplement per day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Control (Low risk genotype) | Experimental | Participants with no genetic variation in their VDR, GC and CYP2R1 genes that would increase their risk of vitamin D deficiency. Participants will be given 10µg vitamin D supplements for 90 days. This group is a control against the medium and high-risk intervention groups. Receives: Dietary Supplement: Vitamin D3 supplement |
| Intervention (Medium risk genotype) | Experimental | Participants with genetic variation in their VDR, GC and CYP2R1 genes that moderately increase their risk of vitamin D deficiency. Participants will be given 10µg vitamin D supplements for 90 days. This group will be compared against the low-risk control group to determine the effect of genetic variations on vitamin D status. Receives: Dietary Supplement: Vitamin D3 supplement |
| Intervention (High risk genotype) | Experimental | Participants with genetic variation in their VDR, GC and CYP2R1 genes that increase their risk of vitamin D deficiency. Participants will be given 10µg vitamin D supplements for 90 days. This group will be compared against the low-risk control group to determine the effect of genetic variations on vitamin D status. Receives: Dietary Supplement: Vitamin D3 supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin D concentration
Effect between genetic variations and vitamin D concentration
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start16 May 2022
- Primary completion25 Aug 2023 (estimated)
- Study completion5 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are grouped based on their genetic risk of vitamin D deficiency, all participants are given 10µg vitamin D supplements for 90 days
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Mary's University, Twickenham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yiannis Mavrommatis, Principal investigator, St. Mary's University, Twickenham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802433
- Sponsor's protocol ID
- SMU_ETHICS_2022-23_004
- Status last verified
- Mar 2023
- First submitted
- 14 Sep 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krasniqi E, Boshnjaku A, Wagner KH, Wessner B. Association between Polymorphisms in Vitamin D Pathway-Related Genes, Vitamin D Status, Muscle Mass and Function: A Systematic Review. Nutrients. 2021 Sep 4;13(9):3109. doi: 10.3390/nu13093109.
PubMed 34578986National Health Service (NHS) (2020) Vitamin D. Available at: https://www.nhs.uk/conditions/vitamins-and-minerals/vitamin-d/
National Institute for Health and Care Excellence (NICE) (2017) Vitamin D: supplement use in specific population groups. Available at: https://www.nice.org.uk/guidance/ph56/
Public Health England (PHE) (2019) National Diet and Nutrition Survey: Years 1 to 9 of the Rolling Programme (2008/2009 - 2016/2017): Time trend and income analyses. Available at: https://assets.publishing.service.gov.uk/
Sepulveda-Villegas M, Elizondo-Montemayor L, Trevino V. Identification and analysis of 35 genes associated with vitamin D deficiency: A systematic review to identify genetic variants. J Steroid Biochem Mol Biol. 2020 Feb;196:105516. doi: 10.1016/j.jsbmb.2019.105516. Epub 2019 Oct 31.
PubMed 31678109
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of VDR rs7311856, GC rs2282679 and CYP2R1 rs2060793 Variants on Vitamin D Status: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05802433
- Acronym / sponsor ID
- SMU_ETHICS_2022-23_004
- Conditions
- Vitamin D Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- St. Mary's University, TwickenhamUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 25 Aug 2023 (estimated)
- Study completion
- 5 Oct 2023 (estimated)
- First posted
- 6 Apr 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.
Vitamin D is essential for skeletal growth and bone health, deficiency causes rickets and osteomalacia. In the UK 29% of adults have vitamin D deficiency. It is recommended all adults take 10µg vitamin D supplement daily. Genetic variations could alter vitamin D status by affecting vitamin D metabolism. Systematic reviews found variations in VDR, GC and CYP2R1 genes are associated with vitamin D deficiency. This study aims to assess the effects between vitamin D supplementation and variations in VDR, GC and CYP2R1 genes on vitamin D status.
Detailed description
The study design is a quantitative, randomised control trial measuring vitamin D concentrations in blood serum. All participants will be given the recommended 10µg daily dose of vitamin D supplementation. Participants will be grouped based on their genotype for each gene, as either low, medium or high-risk genotypes. The low-risk group will act as a control and the medium and high-risk groups will act as the intervention groups.
Participants will attend St Mary's University's applied science laboratory twice. During their first visit participants will provide a 2ml capillary blood sample. Blood samples are collected using lancets to prick participants' ear lobes. The serum is extracted from the blood samples, serum is stored at -80c until analysis. Participants will be given 90 10µg vitamin D supplements and instructed to take one per day for 90 days. Participants will also be instructed to not make any major changes to their habitual diet. During the second visit participants will provide 1 ml of saliva sample into the Collection Pot and a second 2ml sample of blood. Serum samples will be analysed for vitamin D concentrations using 25(OH) Vitamin D ELISA kit. DNA will be extracted from the saliva samples using PSP SalivaGene DNA Kit following the manufacturer's protocol. DNA will be genotyped for variations in the VDR, GC and CYP2R1 genes. Data will be assessed to determine if variations in these genes influenced the effectiveness of vitamin D supplementation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants are grouped based on their genetic risk of vitamin D deficiency, all participants are given 10µg vitamin D supplements for 90 days
| Arm | Type | Receives |
|---|---|---|
| Control (Low risk genotype) | Experimental | Dietary Supplement: Vitamin D3 supplementParticipants with no genetic variation in their VDR, GC and CYP2R1 genes that would increase their risk of vitamin D deficiency. Participants will be given 10µg vitamin D supplements for 90 days. This group is a control against the medium and high-risk intervention groups. |
| Intervention (Medium risk genotype) | Experimental | Dietary Supplement: Vitamin D3 supplementParticipants with genetic variation in their VDR, GC and CYP2R1 genes that moderately increase their risk of vitamin D deficiency. Participants will be given 10µg vitamin D supplements for 90 days. This group will be compared against the low-risk control group to determine the effect of genetic variations on vitamin D status. |
| Intervention (High risk genotype) | Experimental | Dietary Supplement: Vitamin D3 supplementParticipants with genetic variation in their VDR, GC and CYP2R1 genes that increase their risk of vitamin D deficiency. Participants will be given 10µg vitamin D supplements for 90 days. This group will be compared against the low-risk control group to determine the effect of genetic variations on vitamin D status. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults
- female and male
- 18-65 years
- completion of physical activity readiness questionnaire (PAR-Q).
Key exclusion criteria (5 listed)
- Below 18 years
- above 65 years
- individuals taking medications that could interact with vitamin D status
- Individuals regularly taking daily Vitamin D supplementation during the 3 months before the intervention start date
- major dietary changes in vitamin D intake during the intervention period
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 D3 supplement10µg vitamin D3 supplement per day for 90 days | Dietary supplement | Control (Low risk genotype), Intervention (High risk genotype), Intervention (Medium risk genotype) |
Primary outcome
vitamin D concentration
Time frame: 90 days
Effect between genetic variations and vitamin D concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 34578986Krasniqi E, Boshnjaku A, Wagner KH, Wessner B. Association between Polymorphisms in Vitamin D Pathway-Related Genes, Vitamin D Status, Muscle Mass and Function: A Systematic Review. Nutrients. 2021 Sep 4;13(9):3109. doi: 10.3390/nu13093109.
- BackgroundNational Health Service (NHS) (2020) Vitamin D. Available at: https://www.nhs.uk/conditions/vitamins-and-minerals/vitamin-d/
- BackgroundNational Institute for Health and Care Excellence (NICE) (2017) Vitamin D: supplement use in specific population groups. Available at: https://www.nice.org.uk/guidance/ph56/
- BackgroundPublic Health England (PHE) (2019) National Diet and Nutrition Survey: Years 1 to 9 of the Rolling Programme (2008/2009 - 2016/2017): Time trend and income analyses. Available at: https://assets.publishing.service.gov.uk/
- Background: PubMed 31678109Sepulveda-Villegas M, Elizondo-Montemayor L, Trevino V. Identification and analysis of 35 genes associated with vitamin D deficiency: A systematic review to identify genetic variants. J Steroid Biochem Mol Biol. 2020 Feb;196:105516. doi: 10.1016/j.jsbmb.2019.105516. Epub 2019 Oct 31.
- 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.
Yiannis Mavrommatis principal investigator
St. Mary's University, Twickenham
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 D3 supplement in people with Vitamin D Deficiency, run by St. Mary's University, Twickenham 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 4 inclusion and 5 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 6 Apr 2023. 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 Yiannis Mavrommatis (020 8240 4000, yiannis.mavrommatis@stmarys.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vitamin D concentration (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802433, which also lists 5 linked publications.
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 6 Apr 2023.