25-hydroxyvitamin D and Fatigue: The VITALITY Study

NCT ID: NCT01718925

Last Updated: 2015-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

614 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome Inflammatory Bowel Disease Diabetes Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Inflammatory Bowel Disease

Ulcerative Colitis and Crohns's disease patients will be recruited from sqeduled outpatient follow-up

No interventions assigned to this group

Irritable Bowel Syndrome

Irritable Bowel patients will be recruited from sqeduled outpatient follow-up

No interventions assigned to this group

Rheumatoid Arthritis

Rheumatoid Arthritis patients will be recruited from sqeduled outpatient follow-up

No interventions assigned to this group

Diabetes Mellitus

Diabetes mellitus patients will be recruited from sqeduled outpatient follow-up

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Alesund Hospital

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

Ostfold University College

OTHER

Sponsor Role collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars-Petter Jelsness-Jørgensen, PhD

Role: PRINCIPAL_INVESTIGATOR

Ostfold Hospital Trust

Other Identifiers

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3256

Identifier Type: -

Identifier Source: org_study_id

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