Healthy SchoolchildrenNCT01477827
Sunlight Exposure and Vitamin D in Children
An observational study of Healthy Schoolchildren, 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 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 Schoolchildren
- What is being tested?
- None - observational study
- How many people
- 125 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Jul 2012
- 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 in Greater Manchester
Who may be able to join
- Healthy school children aged 12-15 years
- White Caucasian
- Male or female
Who cannot join
- History of photosensitivity disorder
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salford Royal NHS Foundation Trust
Manchester, M6 8HD
About this study
Official title: Sunlight Exposure and Vitamin D Status of Children in the UK
The purpose of this study is to examine the amount of sunlight exposure and vitamin D status of adolescent schoolchildren in each season throughout the year.
- Conditions
- Healthy Schoolchildren
- Being tested
- None - observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None - observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy adolescents aged 12-15 years Receives: Other: None - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of 25-hydroxyvitamin D
Measured: Approximately every 3 months
Secondary outcomes (2)
Amount of 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.
Measured: Approx every 3 months
Dietary intake of vitamin D
Intake of foods containing vitamin D is recorded for a one week period and the average daily intake determined.
Measured: Approximately every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startJun 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SchoolchildrenStudies 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
- 125 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, MBBS MD FRCP, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477827
- Sponsor's protocol ID
- Bupa Protocol 1
- Status last verified
- Jan 2013
- First submitted
- 18 Nov 2011
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sunlight Exposure and Vitamin D Status of Children in the UK
- ClinicalTrials.gov ID
- NCT01477827
- Acronym / sponsor ID
- Bupa Protocol 1
- Conditions
- Healthy Schoolchildren
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Nov 2011 (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 in each season throughout the year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: None - observational studyHealthy adolescents aged 12-15 years |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Schoolchildren in Greater Manchester
Key inclusion criteria (3 listed)
- Healthy school children aged 12-15 years
- White Caucasian
- Male or female
Key exclusion criteria (1 listed)
- History of photosensitivity disorder
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 |
|---|---|---|
| None - observational study | Other | Healthy volunteers |
Primary outcome
Serum concentration of 25-hydroxyvitamin D
Time frame: Approximately every 3 months
2 secondary outcomes
Amount of sunlight exposure received
Time frame: Approx every 3 months
Dietary intake of vitamin D
Time frame: Approximately every 3 months
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 16 Jan 2013.
Related trials for Healthy Schoolchildren
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Recruiting
Multidimensional Intervention in Mexican Schoolchildren
Childhood Obesity, Pediatric Obesity
Enrolling by invitation
Educational VR Game Intervention to Enhance Hygiene Practices in Primary School Children
Healthy Participants
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, MBBS MD FRCP 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 Schoolchildren, 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 3 inclusion and 1 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 16 Jan 2013. 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?
Serum concentration of 25-hydroxyvitamin D (time frame: Approximately every 3 months). 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 16 Jan 2013.