Healthy VolunteersNCT01623414
Sunlight Exposure and Vitamin D Status of Children of South Asian Ethnicity Living in the UK
An observational study of Healthy Volunteers, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The purpose of this study is to examine the amount of sunlight exposure and vitamin D status of adolescent schoolchildren of South Asian ethnicity in each season throughout the year. Read more about this study
- Who is it for?
- Ages 12 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 131 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2012to Oct 2014
- Phase
- Observational
- 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 12 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Schoolchildren of South Asian ethnicity in Greater Manchester
Who may be able to join
- Healthy schoolchildren aged 12-15 years
- Sun-reactive skin type V (naturally brown skin)
- South Asian ethnicity
- Male or female
Who cannot join
- History of photosensitivity disorder
- Non-ambulant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salford Royal NHS Foundation Trust
Manchester, M6 8HD
About this study
The purpose of this study is to examine the amount of sunlight exposure and vitamin D status of adolescent schoolchildren of South Asian ethnicity in each season throughout the year.
- Conditions
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy schoolchildren | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum concentration of 25-hydroxyvitamin D
Serum vitamin D will be assessed every 3 months over a period of 1 year
Measured: 1 year
Secondary outcomes (2)
Change in sunlight exposure received
Exposure to sunlight over 7 consecutive days is measured using polysulphone badges with one badge for weekdays and a second badge for the weekend. Exposure is assessed every 3 months for 1 year.
Measured: 1 year
Change in dietary intake of vitamin D
Intake of foods containing vitamin D is recorded for a one week period once every 3 months over a period of 1 year and the average daily intake determined.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lesley Rhodes, University of Manchester
- Investigators
- Lesley Rhodes, MD FRCP(UK), Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623414
- Sponsor's protocol ID
- AMR-1950
- Status last verified
- Feb 2015
- First submitted
- 13 Jun 2012
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sunlight Exposure and Vitamin D Status of Children of South Asian Ethnicity Living in the UK
- ClinicalTrials.gov ID
- NCT01623414
- Acronym / sponsor ID
- AMR-1950
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Jun 2012 (estimated)
- 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 purpose of this study is to examine the amount of sunlight exposure and vitamin D status of adolescent schoolchildren of South Asian ethnicity in each season throughout the year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy schoolchildren | – | – |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Schoolchildren of South Asian ethnicity in Greater Manchester
Key inclusion criteria (4 listed)
- Healthy schoolchildren aged 12-15 years
- Sun-reactive skin type V (naturally brown skin)
- South Asian ethnicity
- Male or female
Key exclusion criteria (2 listed)
- History of photosensitivity disorder
- Non-ambulant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in serum concentration of 25-hydroxyvitamin D
Time frame: 1 year
Serum vitamin D will be assessed every 3 months over a period of 1 year
2 secondary outcomes
Change in sunlight exposure received
Time frame: 1 year
Change in dietary intake of vitamin D
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
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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.
Lesley Rhodes, MD FRCP(UK) principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by University of Manchester 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 2 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: finished, as of the sponsor's last update on 5 Feb 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum concentration of 25-hydroxyvitamin D (time frame: 1 year). 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 5 Feb 2015.