Chronic Fatigue Following Acute Epstein-Barr Virus Infection in Adolescents

Completed

• Conditions: Fatigue Syndrome, Chronic; Epstein-Barr Virus Infections

• Registration Number: NCT02335437
• Lead Sponsor: University Hospital, Akershus

Brief Summary

Chronic fatigue syndrome (CFS) is characterized by unexplained, disabling and long lasting fatigue, as well as pain, impaired memory, sleep difficulties and other symptoms. Epstein-Barr virus (EBV) infection might precipitate CFS. In this study, 200 adolescents undergoing acute EBV infection will be followed prospectively, and also compared with a group of healthy controls. The aim is twofold:

* To identify factors that predispose to chronic fatigue among adolescents with acute EBV infection

* To compare pathophysiological features of patients with acute EBV infection with a group of healthy controls.

Possible risk factors for chronic fatigue 6 months after EBV-infection includes:

* Severity of the initial infection

* Immune responses characteristics

* Characteristics of the neuroendocrine stress response

* Cognitive functioning

* Emotional disturbances

* Genetics/ epigenetics of candidate genes

* Certain personality traits

* Critical life events

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-09
• Study Start: 2015-03
• Primary Completion: 2016-12
• Status Verified: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• Age ≥ 12 years and < 20 years
• Serological confirmation of acute EBV infection
• Lives in one of the following Norwegian counties: Oslo, Akershus, Buskerud, Østfold, Vestfold

Exclusion Criteria

• Medical treatment for another disease (hormonal conterception and antibiotics against tonsillitis/pharyngitis are accepted)
• Pregnancy
• Debut of illness > 6 weeks ago

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue	6 monhts	Chalder fatigue questionnaire, total score
Steps per day	6 monhts	Mean number of steps/day across 7 consecutive days, measured by accelerometer (ActivePal)

Secondary Outcome Measures

Name	Time	Method
Bodily symptoms	6 monhts	Assessed by different questionnaires
Pain threshold	6 monhts	Assessed by pressure algometry
Autonomic cardiovascular control	6 monhts	Assessed by noninvasive, continuous recordings of heart rate, blood pressures and stroke volume during supine rest.
Cognitive function	6 monhts	Assessed by the instruments WISC-IV, D-KEFS, HVLT-R and WASI.
Functional disability	6 monhts	Assessed by the FDI inventory
Neuroendocrine markers	6 monhts	In particular blood and urine measurements of catecholamines and the HPA axis
Immune markers	6 monhts	In particular blood measurements of cytokines
Quality of life	6 monhts	Assessed by the PedsQL inventory

Trial Locations

Locations (1)

Dept. of Pediatrics, Akershus University Hospital; 🇳🇴 Lørenskog, Akershus, Norway