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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01718925
Other study ID # 3256
Secondary ID
Status Completed
Phase N/A
First received October 29, 2012
Last updated October 14, 2015
Start date October 2012
Est. completion date December 2014

Study information

Verified date October 2015
Source Ostfold Hospital Trust
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

The burden of chronic disease is continuing to rise. Even though patients may be in remission or have quiescent disease, several studies have confirmed that symptoms, such as e.g., fatigue, is troublesome.

The primary aim of this study is to investigate whether or not there might be an association between levels of vitamin D and the subjective experience of fatigue in conditions, such as inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel syndrome.

Secondary aims is to study both the co-occurence and influence of pain, depression and anxiety.


Description:

The burden of chronic disease is continuing to rise. Even though patients may be in remission or have quiescent disease, several studies have confirmed that symptoms, such as e.g., fatigue, is troublesome.Previous studies have confirmed that vitamin D deficiency is associated with both Crohn's disease and Rheumatoid Arthritis. Since Vitamin D is associated with both onset of chronic disease and energy, we aim in this study to assess its impact on fatigue in various chronic diseases.

The primary aim of this study is to investigate whether or not there might be an association between levels of vitamin D and the subjective experience of fatigue in conditions, such as inflammatory bowel disease, diabetes mellitus, rheumatoid arthritis and irritable bowel syndrome.

Secondary aims is to study both the co-occurence and influence of pain, depression and anxiety.


Recruitment information / eligibility

Status Completed
Enrollment 614
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- informed consent,

- over 18 years of age

Exclusion Criteria:

- dementia,

- cognitive disorders,

- not able to comply with the study procedures,

- on active vitamin D treatment

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Locations

Country Name City State
n/a

Sponsors (9)

Lead Sponsor Collaborator
Ostfold Hospital Trust Aarhus University Hospital, Alesund Hospital, Helse Stavanger HF, Karolinska Institutet, Oslo University Hospital, Ostfold University College, Fredrikstad, Norway, Sykehuset Innlandet HF, Sykehuset Telemark

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue Fatigue and the impact of vitamin d levels 2 years No
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