Condition category
Respiratory
Date applied
24/03/2016
Date assigned
31/03/2016
Last edited
30/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Asthma is a long-term condition which affects the airways. It can affect people of any age, however in usually is first spotted during childhood. When a person is suffering from asthma, the bronchi (tubes which carry air in and out of the lungs) can become narrowed or swollen (inflammation). This can cause a range of distressing symptoms such as wheezing, chest tightness and breathlessness. In recent years, a number of studies have shown that there may be a link between the level of vitamin D in the blood and how severe asthma symptoms are in children. Vitamin D is an essential vitamin which our bodies produce when sunlight shines on the skin. The aim of this study is to evaluate the vitamin D levels in children with asthma and healthy control group in order to find out whether there is a relationship between vitamin D levels and asthma.

Who can participate?
Children aged between 7 and 17 with asthma and healthy children of the same age.

What does the study involve?
Children with asthma have a sample of blood taken so that it can be used to test the level of vitamin D in the blood, as well as levels of allergen-spesific IgE (a chemical marker for asthma). These participants also have their lung function tested through a breathing test, which is repeated three times so the most accurate result can be obtained. This involves taking a deep breath in and then blowing into a tube attached to a machine as hard as possible to measure how well the lungs are functioning. Healthy children have a sample of blood taken so that it can be tested for vitamin D levels. The vitamin D levels are then compared between the groups in order to find out if there is a link to asthma. In addition, the severity of asthma symptoms in the asthmatic children are compared to their vitamin D levels.

What are the possible benefits and risks of participating?
Participants who are found to have low levels of vitamin D will benefit from receiving a referral to a specialist in order to treat them. There are no notable risks involved with taking part in the study.

Where is the study run from?
Sisli Hamidiye Etfal Research and Training Hospital (Turkey)

When is the study starting and how long is it expected to run for?
September 2011 to June 2013

Who is funding the study?
Sisli Hamidiye Etfal Research and Training Hospital (Turkey)

Who is the main contact?
Dr Sebnem Ozdogan
Etfal.EtikKurul@sislietfal.gov.tr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sebnem Ozdogan

ORCID ID

Contact details

Sisli Hamidiye Etfal Research and Training Hospital Ethic Committee
Halaskargazi Cad
Etfal Sok. Sisli-Istanbul/Turkey
Istanbul
34371
Turkey
+90 212 3735000 6565
Etfal.EtikKurul@sislietfal.gov.tr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

527

Study information

Scientific title

Association between vitamin D levels and pulmonary function parameters in children with asthma

Acronym

Study hypothesis

There is a correlation between serum vitamin D levels and pulmonary function in children with asthma.

Ethics approval

Ethics Committee of Sisli Hamidiye Etfal Research and Training Hospital, 19/11/2012, ref: 527

Study design

Single-centre case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Asthma

Intervention

A total of 71 patients between 7 and 17 years of age with diagnosis of asthma will be included in the study as patient group. A total of 77 healthy children who presents for routine physical in pediatrics will be included as a control group.

Asthma group: The investigator will inform the patients and their families about the study. In the first visit: Demographic information such as age, gender, history of hospitalization for asthma attack in the previous year, the parental history of asthma, will be recorded. Each participant’s body weight and height will be measured. Blood samples will be obtained from the asthma group to measure serum total IgE levels, allergen-spesific IgE levels (using an inhalant phadiotop panel) and vitamin D levels (If total IgE and allergen specific IgE were measured before, we will use the previous records). Pulmonary function tests will be obtained by a pediatric pulmonologist.

Control group: The investigator will inform the children and their families about the study. After obtaining demograghics, only vitamin D levels will be measured.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Vitamin D levels are measured using blood testing at the study visit
2. Pulmonary function (in asthma patients only) is measured using blood testing for serum total IgE levels at the study visit and correlated to vitamin D levels

Secondary outcome measures

Association between vitamin D levels and asthma clinical features (in asthma patients only) are measured through serum vitamin D testing and pulmonary function tests (spirometry) completed by a by a pediatric pulmonologist at the study visit.

Overall trial start date

30/09/2011

Overall trial end date

30/06/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Patient inclusion criteria:
1. Aged between 7 and 17 years
2. Asthma diagnosis
3. Followed at the pediatric outpatient pulmonology clinics between December 2012 and March 2013

Healthy controls inclusion criteria:
1. Aged between 7 and 17 years
2. Healthy

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

148

Participant exclusion criteria

1. Patients with chronic diseases other than asthma (renal, hepatic, endocrine, metabolic, or neurological disorders)
2. Those taking vitamin D supplements, anti-epileptic drugs or systemic steroids=

Recruitment start date

01/11/2012

Recruitment end date

20/03/2013

Locations

Countries of recruitment

Turkmenistan

Trial participating centre

Sisli Hamidiye Etfal Research and Training Hospital
Istanbul
34742
Turkey

Sponsor information

Organisation

Sisli Hamidiye Etfal Research and Training Hospital

Sponsor details

Halaskargazi cad. etfal sok.
Sisli-Istanbul
34371
Turkey
+90 2123735000
ozdogan65@hotmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Sisli Hamidiye Etfal Research and Training Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

30/04/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes