NCT01623414

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

1.1 years

First QC Date

June 13, 2012

Last Update Submit

February 4, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in serum concentration of 25-hydroxyvitamin D

    Serum vitamin D will be assessed every 3 months over a period of 1 year

    1 year

Secondary Outcomes (2)

  • Change in sunlight exposure received

    1 year

  • Change in dietary intake of vitamin D

    1 year

Study Arms (1)

Healthy schoolchildren

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Schoolchildren of South Asian ethnicity in Greater Manchester

You may qualify if:

  • Healthy schoolchildren aged 12-15 years
  • Sun-reactive skin type V (naturally brown skin)
  • South Asian ethnicity
  • Male or female

You may not qualify if:

  • History of photosensitivity disorder
  • Non-ambulant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salford Royal NHS Foundation Trust

Manchester, M6 8HD, United Kingdom

Location

Study Officials

  • Lesley Rhodes, MD FRCP(UK)

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Experimental Dermatology

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 20, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2014

Last Updated

February 5, 2015

Record last verified: 2015-02

Locations