Clinical trial NCT01718925: 25-hydroxyvitamin D and Fatigue: The VITALITY Study
Official title: Vitamin D, Fatigue and Patient Reported Outcome (PRO) in Chronic Somatic and Functional Disorders.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Inflammatory Bowel Disease
Diabetes
Rheumatoid Arthritis
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Aarhus University Hospital
name: Oslo University Hospital
name: Alesund Hospital
name: Helse Stavanger HF
name: Sykehuset Telemark
name: Sykehuset Innlandet HF
name: Ostfold University College
First posted: 2012-11-01
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an established diagnose of IBD, DIA, IBS or RA is eligible for inclusion in this study. Patients must be over 18 years of age. Disease activity will be measured using the SCCAI for ulcerative colitis, SCDAI for Crohn's disease, DAS-28 for rheumatoid arthritis. In Dia and IBD objective activity measures, such as calprotectin in stools and HbA1C, will be collected.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Fatigue
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ostfold Hospital Trust
name: Lars-Petter Jelsness-Jørgensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: