Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

Diagnosis of sarcoidosis, confirmed by histology or cytology
Age 18-60 years
No affected organ requiring high dose immunosuppressive therapy
...
Diagnosis of sarcoidosis, confirmed by histology or cytology
Age 18-60 years
No affected organ requiring high dose immunosuppressive therapy
Short Form - 36 subscale physical functioning score < 70 points

Exclusion Criterias

Obesity (BMI > 30)
Pregnancy of lactation
Diagnosis of glaucoma, osteoporosis, history of fractures
...
Obesity (BMI > 30)
Pregnancy of lactation
Diagnosis of glaucoma, osteoporosis, history of fractures
Current use of carbamazepin, fenytoin, rifampicin
History of gastric ulcera in the past 12 months
Allergy to corticosteroids
Current use of Non Steroidal Anti Inflammatory Drug without co-prescription of Proton Pump Inhibitor

Summary

Conditions
Sarcoidosis
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

The orphan disease sarcoidosis causes a major reduction in quality of life and loss of work productivity, especially in young adults. Most patients are diagnosed between the age of 20-40 years. In sarcoidosis, multiple organs are affected by inflammation; the cause of the disease is unknown and no c...

The orphan disease sarcoidosis causes a major reduction in quality of life and loss of work productivity, especially in young adults. Most patients are diagnosed between the age of 20-40 years. In sarcoidosis, multiple organs are affected by inflammation; the cause of the disease is unknown and no curative medication exists. Sarcoidosis invalidates the lives of most patient for many years. Although curative (pharmaco) therapy is not on hand, immunosuppressive drugs may control the symptoms of the disease. These symptoms are caused by the inflammation in multiple organs, foremost the lungs and the lymphoid system. However, 90% of the sarcoidosis patients receives no immunosuppressive medication at all during the first months after diagnosis, even though the immune system is then highly activated and patients suffer from severe complaints like malaise, fatigue and pain. This wait-and-see policy is common international practice, but scientific grounds and official guidelines are lacking. This project examines whether low grade suppression of the initial inflammatory process of sarcoidosis by intervention with low-dose dexamethasone therapy achieves significant alleviation of (sub-)acute symptoms, improvement in quality of life, increase in work productivity, and whether this intervention prevents disease progression and reduces total health-care costs.

Inclusion Criterias

Diagnosis of sarcoidosis, confirmed by histology or cytology
Age 18-60 years
No affected organ requiring high dose immunosuppressive therapy
...
Diagnosis of sarcoidosis, confirmed by histology or cytology
Age 18-60 years
No affected organ requiring high dose immunosuppressive therapy
Short Form - 36 subscale physical functioning score < 70 points

Exclusion Criterias

Obesity (BMI > 30)
Pregnancy of lactation
Diagnosis of glaucoma, osteoporosis, history of fractures
...
Obesity (BMI > 30)
Pregnancy of lactation
Diagnosis of glaucoma, osteoporosis, history of fractures
Current use of carbamazepin, fenytoin, rifampicin
History of gastric ulcera in the past 12 months
Allergy to corticosteroids
Current use of Non Steroidal Anti Inflammatory Drug without co-prescription of Proton Pump Inhibitor

Locations

Nieuwegein, 3430 EM
Nieuwegein, 3430 EM

Tracking Information

NCT #
NCT01920919
Collaborators
Not Provided
Investigators
Not Provided