25-hydroxyvitamin D and Fatigue: The VITALITY Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by Ostfold Hospital Trust
Sponsor:
Collaborators:
Karolinska Institutet
Aarhus University Hospital
Oslo University Hospital
Alesund Hospital
Helse Stavanger HF
Sykehuset Telemark
Sykehuset Innlandet HF
Ostfold University College, Fredrikstad, Norway
Information provided by (Responsible Party):
Ostfold Hospital Trust
ClinicalTrials.gov Identifier:
NCT01718925
First received: October 29, 2012
Last updated: October 31, 2012
Last verified: October 2012

October 29, 2012
October 31, 2012
October 2012
June 2014   (final data collection date for primary outcome measure)
Fatigue [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Fatigue and the impact of vitamin d levels
Same as current
Complete list of historical versions of study NCT01718925 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
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Non-Probability Sample

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.

  • Irritable Bowel Syndrome
  • Inflammatory Bowel Disease
  • Diabetes
  • Rheumatoid Arthritis
Not Provided
  • Inflammatory Bowel Disease
    Ulcerative Colitis and Crohns's disease patients will be recruited from sqeduled outpatient follow-up
  • Irritable Bowel Syndrome
    Irritable Bowel patients will be recruited from sqeduled outpatient follow-up
  • Rheumatoid Arthritis
    Rheumatoid Arthritis patients will be recruited from sqeduled outpatient follow-up
  • Diabetes Mellitus
    Diabetes mellitus patients will be recruited from sqeduled outpatient follow-up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1100
January 2015
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Lars-Petter Jelsness-Jorgensen, Ph.D lars.p.jelsness-jorgensen@hiof.no
Not Provided
 
NCT01718925
3256
No
Ostfold Hospital Trust
Ostfold Hospital Trust
  • Karolinska Institutet
  • Aarhus University Hospital
  • Oslo University Hospital
  • Alesund Hospital
  • Helse Stavanger HF
  • Sykehuset Telemark
  • Sykehuset Innlandet HF
  • Ostfold University College, Fredrikstad, Norway
Principal Investigator: Lars-Petter Jelsness-Jørgensen, PhD Ostfold Hospital Trust
Ostfold Hospital Trust
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP