CompletedNCT03108547Updated Apr 11, 2017

Hair Cortisol and Testosterone Levels in Patients With Sarcoidosis

An observational study in Sarcoidosis, sponsored by Erasmus Medical Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-11.

Sponsored by Erasmus Medical Center · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 32
Ages: 18 Years and older
Sex: All

Study summary

The investigators studied whether scalp hair cortisol and testosterone levels differed between sarcoidosis patients both with and without fatigue and healthy controls.

Read the detailed description

Rationale: Fatigue is a common symptom in patients with sarcoidosis and has great impact on quality of life. Several aspects in the pathogenesis of sarcoidosis and co-morbidities accompanying sarcoidosis could contribute to fatigue. However, until now the etiology of fatigue in sarcoidosis is unknown. Measurements of steroid hormones in scalp hair could possibly be directional in elucidating the underlying mechanism and could also be used as a screening and follow up tool in interventional studies.

Objective: A pilot to investigate whether cortisol and testosterone levels measured in hair differ between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue and healthy subjects.

Study design: A prospective observational study, using hair samples of sarcoidosis patients with and without fatigue, compared to an already existing age matched healthy control group.

Study population: Adult sarcoidosis patients at the outpatient clinic of the pulmonary department of the Erasmus MC, Rotterdam Main study parameters/endpoints: Cortisol and testosterone levels in scalp hair, correlation with Fatigue Assessment Scale.

Conditions studied

Sarcoidosis

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Keywords

Sarcoidosis
Scalp hair cortisol and testosterone
Fatigue
Biomarker
Psychological distress

In context

Sarcoidosis

285 studies on the registry are indexed under Sarcoidosis; 58 are open to participants now.

This study's enrollment of 32 is below the median of 124 across 109 observational studies indexed under Sarcoidosis.

Browse Sarcoidosis studies →

Lead sponsor

Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.

Browse Erasmus Medical Center studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Sampling method: Probability sample

Study population

Diagnosis of sarcoidosis based on consistent clinical features/BAL fluid analysis/ PA according to the latest ATS/ERS/WASOG statement on sarcoidosis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age of at least 18 years
Diagnosis of sarcoidosis based on consistent clinical features/BAL fluid analysis/ PA according to the latest ATS/ERS/WASOG statement on sarcoidosis
Able to speak, read and write in Dutch
Presence of sarcoidosis related fatigue, defined as a ≥ 22 score on the Fatigue Assessment Scale
Other causes of fatigue are excluded or contributing comorbidities are optimally treated (e.g. OSAS, hypothyroidism or anemia)

Exclusion criteria

Exclusion Criteria:

Unable to understand questionnaires (intellectual impaired or language barrier)
Hair length \< 1 cm
Use of systemic and/ or inhalation steroids in the last year
Use of methylphenidate (Ritalin) \< 1 month before the study

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 32 participants (actual)
Patient registry: No
Biospecimen retention: Samples without dna

Groups and cohorts

Sarcoidosis - fatigued
Men and women with sarcoidosis and a score of ≥ 22 on the Fatigue Assessment Scale. A small hair sample will be cut and the participants will be asked to complete questionnaires on fatigue, anxiety, depression, stress and quality of life.
Other: Determination of scalp hair steroids
Sarcoidosis - non-fatigued
Men and women with sarcoidosis and a score of \< 22 on the Fatigue Assessment Scale. A small hair sample will be cut and the participants will be asked to complete questionnaires on fatigue, anxiety, depression, stress and quality of life.
Other: Determination of scalp hair steroids
Healthy controls
Hair steroid values of a previously collected normal values study in adults will be used as healthy controls
Other: Determination of scalp hair steroids

Interventions

OtherDetermination of scalp hair steroids

What researchers measure

Primary outcomes

Scalp hair cortisol differences between sarcoidosis patients with and without fatigue and healthy controls
Differences between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue, and healthy controls
Time frame: 1 month

Secondary outcomes

Scalp hair testosterone differences between sarcoidosis patients with and without fatigue and healthy controls
Differences between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue, and healthy controls
Time frame: 1 month
Scalp hair cortisone differences between sarcoidosis patients with and without fatigue and healthy controls
Differences between patients with sarcoidosis related fatigue, sarcoidosis patients without fatigue, and healthy controls
Time frame: 1 month
Fatigue Assessment Scale (FAS)
A short validated questionnaire to assess fatigue in sarcoidosis, and its relation to scalp hair steroids
Time frame: 1 day
King's Sarcoidosis Questionnaire (KSQ)
A validated questionnaire to assess sarcoidosis-related health status, and its relation to scalp hair steroids
Time frame: 1 day
EuroQol-5D-5L (EQ-5D-5L)
A validated generic questionnaire to assess general health status, and its relation to scalp hair steroids
Time frame: 1 day
Short Form-36 (SF-36)
A validated generic questionnaire to assess health-related quality of life, and its relation to scalp hair steroids
Time frame: 1 day
Perceived Stress Scale
A validated questionnaire to assess perception of stress, and its relation to scalp hair steroids
Time frame: 1 day
Hospital Anxiety and Depression Scale
A validated questionnaire to identify presence of depression and anxiety, and their relation to scalp hair steroids
Time frame: 1 day
% predicted forced vital capacity (FVC)
To assess the relationship between scalp hair steroids and FVC
Time frame: 1 day
% predicted diffusion capacity of carbon monoxide (DLCO)
To assess the relationship between scalp hair steroids and DLCO
Time frame: 1 day
6-minute walk distance test (6MWT)
To assess the relationship between scalp hair steroids and 6MWT
Time frame: 1 day
Waist circumference
To assess the relationship between scalp hair steroids and waist circumference
Time frame: 1 day
Body Mass Index (BMI)
To assess the relationship between scalp hair steroids and BMI
Time frame: 1 day

Study locations

No study locations are listed for this record.

References and documents

Publications

van Manen MJG, Wester VL, van Rossum EFC, van den Toorn LM, Dorst KY, de Rijke YB, Wijsenbeek MS. Scalp hair cortisol and testosterone levels in patients with sarcoidosis. PLoS One. 2019 Jun 14;14(6):e0215763. doi: 10.1371/journal.pone.0215763. eCollection 2019. PubMed 31199799 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2014 to primary completion in Jan 2015, 6 months.

Of 62 non-industry observational studies under Sarcoidosis, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 163. This study's 6 months is below that.

Counting every sponsor, half of 62 studies reached it within 52 months; a quarter within 22 and three quarters within 163.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 31, 2017
First posted: Apr 11, 2017
StartActual: Jun 13, 2014
Primary completionActual: Jan 5, 2015
CompletionActual: Jan 5, 2015
Last update: Apr 11, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03108547
Lead sponsor: Erasmus Medical Center
Responsible party: Marlies Wijsenbeek (Principal Investigator, Erasmus Medical Center) — Principal investigator
First posted: Apr 11, 2017
Start date: Jun 13, 2014
Primary completion: Jan 5, 2015
Completion: Jan 5, 2015
Last update: Apr 11, 2017

Study contacts

M. S. Wijsenbeek, MD, PhD

principal investigator · Erasmus University Medical Center, Rotterdam, the Netherlands

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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