Sunlight Exposure and Vitamin D in Children | NCT01477827

Studies
Sunlight Exposure and Vitamin D in Children

NCT01477827

Sponsor

University of Manchester

Status

Completed

Last Update Posted

Jan 16, 2013Estimated

Enrollment

125Actual

Phase

Not provided

Conditions

Healthy Schoolchildren

Interventions

None - observational study

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Nov 18, 2011

First Submission Date that Met QC Criteria

Nov 18, 2011

First Posted Date

Nov 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2013

Last Update Posted Date

Jan 16, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lesley Rhodes, Professor of Experimental Dermatology, University of ManchesterPrincipal Investigator

Lead Sponsor

University of ManchesterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy volunteers		Healthy adolescents aged 12-15 years	Other: None - observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
None - observational study	Other		Healthy volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum concentration of 25-hydroxyvitamin D		Approximately every 3 months

Secondary Outcomes

Measure	Description	Time Frame
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.	Approx every 3 months
Dietary intake of vitamin D

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy school children aged 12-15 years
White Caucasian
Male or female

Exclusion Criteria:

History of photosensitivity disorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Schoolchildren in Greater Manchester

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lesley Rhodes, MBBS MD FRCP	University of Manchester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Salford Royal NHS Foundation Trust		Manchester		M6 8HD	United Kingdom