1 To evaluate the feasibility to measure cortisol levels in hair in healthy children and children with asthma who use inhaled corticosteroids2 To evaluate differences in cortisol levels in hair in healthy children and children with asthma who useā¦
ID
Source
Brief title
Condition
- Adrenal gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cortisol levels in hair samples
Secondary outcome
Correlation between salivary cortisol levels and cortisol levels in hair samples
Association between cortisol levels (in saliva and hair) and symptomscore and
lungfunction
Background summary
Children with asthma have significant lower salivary cortisol levels than their
healthy counterparts. Measurement of cortisol levels in saliva is attractive
since it is non-invasive. Time of saliva collection, medication, food, stress
and infection may affect cortisol levels in saliva. Recently it has been
demonstrated in adults that longitudinal cortisol levels can be measured in
hair. In children this has never been studied. We want to evaluate the
feasibility of cortisol measurement in hair samples in children and also to
determine whether cortisol levels in hair give better insight in the effect of
chronic inhaled corticosteroid use on the pituitary-adrenal axis.
Study objective
1 To evaluate the feasibility to measure cortisol levels in hair in healthy
children and children with asthma who use inhaled corticosteroids
2 To evaluate differences in cortisol levels in hair in healthy children and
children with asthma who use inhaled corticosteroids
3 To evaluate the correlation between single measurement of salivary cortisol
levels and cortisol levels in healthy children and children with asthma who use
inhaled corticosteroids
Study design
Observational
Study burden and risks
The investigator will visit the children at home to collect a hair sample and
give information about the collection of a saliva . The children with asthma
will also perform lungfunction. This visit will take approximately 30 minutes.
The next morning the children will chew on a cotton wool swab for 1 to 2
minutes and mail this saliva sample to the hospital. There are no visits to the
hospital.
We don not expect any risks for the participants
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Henri Dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
Inclusion criteria
Healthy children: prepubertal (6-12 years), no use of steroids or medication with a potential effect on steroidmetabolism;Children with asthma: prepubertal (6-12 years), stable asthma (no additional use of medication in previous three months, no use of systemic steroids in previous three months, normal lungfunction (FEV1 >90% of predicted value)
Exclusion criteria
Informed consent not obtained
If the child and/or parents refuses to participate or cooperate during the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL43231.099.13 |