- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05802433
The Genetic Effects on Vitamin D Supplementation
Effects of VDR rs7311856, GC rs2282679 and CYP2R1 rs2060793 Variants on Vitamin D Status: A Randomised Control Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yiannis Mavrommatis
- Phone Number: 020 8240 4000
- Email: yiannis.mavrommatis@stmarys.ac.uk
Study Locations
-
-
Lobdon
-
London, Lobdon, United Kingdom, TW1 4SX
- Recruiting
- St Mary's University Twickenham
-
Contact:
- Yiannis Mavrommatis
- Phone Number: 020 8240 4000
- Email: yiannis.mavrommatis@stmarys.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adults
- female and male
- 18-65 years
- completion of physical activity readiness questionnaire (PAR-Q).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control (Low risk genotype)
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.
|
10µg vitamin D3 supplement per day for 90 days
|
Experimental: Intervention (Medium risk genotype)
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.
|
10µg vitamin D3 supplement per day for 90 days
|
Experimental: Intervention (High risk genotype)
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.
|
10µg vitamin D3 supplement per day for 90 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vitamin D concentration
Time Frame: 90 days
|
Effect between genetic variations and vitamin D concentration
|
90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yiannis Mavrommatis, St. Mary's University, Twickenham
Publications and helpful links
General 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.
- National 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMU_ETHICS_2022-23_004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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