The Genetic Effects on Vitamin D Supplementation

NCT05802433 | Unknown

• 1 other identifier: SMU_ETHICS_2022-23_004
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• vitamin D concentration

  Effect between genetic variations and vitamin D concentration

  90 days

Study Arms (3)

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.

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.

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.

Dietary Supplement: Vitamin D3 supplement

Interventions

Vitamin D3 supplement DIETARY_SUPPLEMENT

10µg vitamin D3 supplement per day for 90 days

Control (Low risk genotype); Intervention (High risk genotype); Intervention (Medium risk genotype)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults
• female and male
• years
• completion of physical activity readiness questionnaire (PAR-Q).

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Mary's University, Twickenham: lead

Study Sites (1)

St Mary's University Twickenham

London, Lobdon, TW1 4SX, United Kingdom

RECRUITING

Related Publications (5)

• 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.

  PMID: 34578986 BACKGROUND

• National Health Service (NHS) (2020) Vitamin D. Available at: https://www.nhs.uk/conditions/vitamins-and-minerals/vitamin-d/

  BACKGROUND

• 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/

  BACKGROUND

• 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/

  BACKGROUND

• 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.

  PMID: 31678109 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Yiannis Mavrommatis

  St. Mary's University, Twickenham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiannis Mavrommatis

CONTACT

020 8240 4000; yiannis.mavrommatis@stmarys.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are not informed of their genetic variations until completion of the trial
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are grouped based on their genetic risk of vitamin D deficiency, all participants are given 10µg vitamin D supplements for 90 days

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: April 6, 2023
• Study Start: May 16, 2022
• Primary Completion: August 25, 2023
• Study Completion: October 5, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)