ISRCTN ISRCTN72674753
DOI https://doi.org/10.1186/ISRCTN72674753
IRAS number 235670
Secondary identifying numbers 36225
Submission date
13/08/2018
Registration date
05/09/2018
Last edited
09/09/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
We get most of our vitamin D through exposure to ultraviolet (UV) in sunlight and a small amount from our diet. When skin exposed to sunlight, a molecule called 7-DHC is converted to vitamin D which then enters the bloodstream. The aim of this study is to see if there is a difference between young and older adults in how much Vitamin D their skin is able to produce in response to sunlight.

Who can participate?
Healthy White Caucasian volunteers in two age groups, young (18-40 years) and aged (65-89 years)

What does the study involve?
Volunteers receive a single UV exposure, equivalent to 15 minutes of sunlight exposure in Manchester at midday in June. Skin area exposed reflects casual summer clothing (T shirt and shorts) with lower legs, arms, hands, neck and face exposed. A 10 x 10cm square is cut out of the shorts to allow exposure of an upper buttock area for a skin sample. This work is done between November and February when there is low UV and people have the lowest vitamin D levels. Blood samples are taken before UV exposure and 24 hours and 1 week after UV exposure. Skin samples from the previously protected upper buttock are taken from an unexposed area of skin and from the exposed area of skin immediately after UV exposure. Further samples are taken from the exposed area of skin at 24 hours after UV exposure. Skin and blood samples are tested for vitamin D and related molecules.

What are the possible benefits and risks of participating?
The findings will address a significant knowledge gap - whether the ability to synthesise Vitamin D in skin changes with age. Participants will be informed not to expect individual benefit from participation in the study. Some discomfort may be felt when taking blood and skin samples.

Where is the study run from?
Salford Royal NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
October 2017 to September 2021

Who is funding the study?
Biotechnology and Biological Sciences Research Council (UK)

Who is the main contact?
Professor Lesley Rhodes, lesley.e.rhodes@manchester.ac.uk

Contact information

Mrs Lesley Rhodes
Scientific

Photobiology Unit
Dermatology Centre
Salford Royal Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

Phone +44 (0)161 206 1150
Email lesley.e.rhodes@manchester.ac.uk
Prof Lesley Rhodes
Public

Photobiology Unit
Dermatology Centre
Salford Royal Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

Phone +44 (0)161 206 1150
Email lesley.e.rhodes@manchester.ac.uk
Ms Octavia Borecka
Scientific

-
Manchester
-
United Kingdom

ORCiD logoORCID ID 0000-0003-4446-9989
Email octavia.borecka@gmail.com

Study information

Study designNon-randomised; Interventional; Design type: Clinical Laboratory Study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeOther
Participant information sheet ISRCTN72674753_PIS_25Jul18.pdf
Scientific titleAge-related ability to synthesise vitamin D in the skin on exposure to sunlight
Study acronymAGE_D
Study hypothesisDo the skin levels of 7-dehydrocholesterol (DHC) differ in skin of younger and older adults when assessed under carefully controlled protocols, and is the ability of skin to synthesise Vitamin D following ultraviolet radiation exposure, under conditions similar to natural sunlight, different in younger and older adults?
Ethics approval(s)North West - Greater Manchester West Research Ethics Committee, 25/07/2018, ref: 18NW0493
ConditionVitamin D deficiency
InterventionThis is a trial of low-level UVR exposures in a comparative study of human volunteers in 2 age groups, young (18-40 years) and aged (65-89 years). Volunteers will be matched for other attributes including skin type and UV dose administered. Biopsy and blood sampling procedures will be identical. All visits and procedures will be undertaken in the Photobiology Unit, Salford Royal NHS Foundation Trust. Volunteers will receive a single UV exposure, equivalent to 15 minutes of sunlight exposure in Manchester at midday in June. Skin area exposed will reflect casual summer clothing (T shirt and shorts) with lower legs, arms, hands, neck and face exposed (~35% skin surface area). A 10 x 10cm square will be cut out of the short to allow exposure of an upper buttock area for post-UV biopsy. This work will be done between November and February when there is negligible ambient UV and subjects are at their lowest vitamin D status.

Blood samples will be taken pre-UV, and at 24 hours and 1 week post-UV. Skin biopsies from previously protected upper buttock will be taken from an unexposed area of skin and from the exposed area of skin immediately post-UV exposure. Further biopsies will be taken from the exposed area of skin at 24 hours post-UV. Skin samples will be analysed for 7-DHC, pre-vitamin D and vitamin D. Skin biopsy samples will undergo extraction, chromatographic separation, and quantification using tandem mass spectrometry to measure epidermal and dermal content of 7-DHC, pre-vitamin D and related molecules; similar techniques will provide for 25(OH)D analysis of blood samples.

Volunteers will complete a daily diet diary for 1 week and lifestyle questionnaire, as used in previous studies by our group, to assess their dietary sources of vitamin D and general daylight exposure behaviour. Outcomes can be set in context of data from our existing studies of large numbers of younger and older adults showing annual cycles in vitamin D status. Findings will address a significant knowledge gap - whether the ability to synthesise Vitamin D in human skin changes with age.
Intervention typeOther
Primary outcome measureSkin level of 7-DHC measured by tandem mass spectrometry at baseline and 24 hours post-UVR intervention
Secondary outcome measures1. Skin level of pre-vitamin D and vitamin D measured by tandem mass spectrometry at baseline and 24 hours post-UVR intervention
2. Serum 25-hydroxyvitamin D measured by tandem mass spectrometry at baseline and 1 week post-UVR intervention
3. Daily dietary vitamin D intake assessed by diet diary over 1 week
Overall study start date01/10/2017
Overall study end date30/09/2021

Eligibility

Participant type(s)Healthy volunteer
Age groupMixed
Lower age limit18 Years
Upper age limit89 Years
SexBoth
Target number of participantsPlanned Sample Size: 24; UK Sample Size: 24
Total final enrolment25
Participant inclusion criteria1. Healthy, ambulant human volunteers
2. Male and female
3. Aged 18-40 or 65-89 years
4. White Caucasian (sun-reactive skin types I-III)
Participant exclusion criteria1. History of photosensitivity disorder or skin cancer
2. Taking photoactive or bone active therapies
3. Sunbathing/sunny holiday/sunbed use in past 3 months
4. Taking vitamin D doses > 200 IU (5 µg)
5. Taking anti-coagulation medicines including Aspirin, Clopidogrel and Warfarin or Propranolol
Recruitment start date01/10/2018
Recruitment end date30/03/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Salford Royal Hospital
Photobiology Unit
Stott Lane
Salford
M6 8HD
United Kingdom

Sponsor information

The University of Manchester
University/education

Faculty of Biology, Medicine and Health
1.21a Simon Building
Manchester
M13 9PL
England
United Kingdom

Phone +44 (0)161 275 5436
Email FBMHethics@manchester.ac.uk
ROR logo "ROR" https://ror.org/027m9bs27

Funders

Funder type

Research council

Biotechnology and Biological Sciences Research Council; Grant Codes: BB/M011208/1
Government organisation / National government
Alternative name(s)
UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
Location
United Kingdom

Results and Publications

Intention to publish date30/09/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planOutcomes will be communicated to the research community through publication in high-impact open access general and specialist journals within one year of the study end-date. Findings will be communicated to wider audiences via relevant charities and societies promoting research and public education, including the BBSRC (funder). Communication of findings to UK government bodies formulating health policy and guidance relating to vitamin D acquisition will be expedited through the investigatory team’s several active roles on relevant public health and medical committees.
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from the Principal Investigator Prof. Lesley Rhodes (Lesley.e.rhodes@manchester.ac.uk). Data will be available following primary publication of study results. Consent for data sharing will be obtained from participants and all shared data will be fully anonymised.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 25/07/2018 05/09/2018 No Yes
Protocol file version v1 23/03/2018 05/09/2018 No No
Other publications analysis of behaviours influencing vitamin D intake 24/03/2021 13/08/2021 Yes No
Statistical Analysis Plan 18/07/2023 No No
Results article 12/04/2024 09/09/2024 Yes No

Additional files

ISRCTN72674753_PIS_25Jul18.pdf
Uploaded 05/09/2018
ISRCTN72674753_PROTOCOL_v1_23Mar18.pdf
Uploaded 05/09/2018
ISRCTN72674753_SAP.pdf

Editorial Notes

09/09/2024: Publication reference added.
12/03/2024: The following changes were made to the trial record:
1. The IRAS number was added.
2. The intention to publish date was changed from 30/09/2023 to 30/09/2024.
18/07/2023: SAP file uploaded.
12/09/2022: The following changes have been made:
1. The intention to publish date has been changed from 30/09/2022 to 30/09/2023.
2. A scientific contact has been added.
18/10/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/09/2020 to 30/09/2021.
2. The intention to publish date was changed from 30/09/2021 to 30/09/2022.
3. The plain English summary was updated to reflect these changes.
13/08/2021: Internal review.
03/06/2021: The scientific contact has been changed.
24/05/2021: The following changes have been made:
1. A public contact has been added and the plain English summary updated accordingly.
2. Publication reference added.
05/04/2019: Final enrolment number added.
28/03/2019: The condition has been changed from "Specialty: Dermatology, Primary sub-specialty: Dermatology; UKCRC code/ Disease: Metabolic and Endocrine/ Other nutritional deficiencies" to "Vitamin D deficiency" following a request from the NIHR. The condition category has been changed from 'Skin and Connective Tissue Diseases' to 'Nutritional, Metabolic, Endocrine'.
05/09/2018: Uploaded protocol Version 1, 23 March 2018 (not peer reviewed).