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25-hydroxyvitamin D and Fatigue: The VITALITY Study

Vitamin D, Fatigue and Patient Reported Outcome (PRO) in Chronic Somatic and Functional Disorders.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01718925
Enrollment
614
Registered
2012-11-01
Start date
2012-10-31
Completion date
2014-12-31
Last updated
2015-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Inflammatory Bowel Disease, Irritable Bowel Syndrome, Rheumatoid Arthritis

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Karolinska Institutet
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
Oslo University Hospital
CollaboratorOTHER
Alesund Hospital
CollaboratorOTHER
Helse Stavanger HF
CollaboratorOTHER_GOV
Sykehuset Telemark
CollaboratorOTHER_GOV
Sykehuset Innlandet HF
CollaboratorOTHER
Ostfold University College
CollaboratorOTHER
Ostfold Hospital Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fatigue2 yearsFatigue and the impact of vitamin d levels

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026