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25-hydroxyvitamin D and Fatigue: The VITALITY Study

This study has been completed.
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 14, 2015
Last verified: October 2015
  Purpose

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.


Condition
Irritable Bowel Syndrome
Inflammatory Bowel Disease
Diabetes
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Vitamin D, Fatigue and Patient Reported Outcome (PRO) in Chronic Somatic and Functional Disorders.

Resource links provided by NLM:


Further study details as provided by Ostfold Hospital Trust:

Primary Outcome Measures:
  • Fatigue [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Fatigue and the impact of vitamin d levels


Enrollment: 614
Study Start Date: October 2012
Study Completion Date: December 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718925

Sponsors and Collaborators
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
Investigators
Principal Investigator: Lars-Petter Jelsness-Jørgensen, PhD Ostfold Hospital Trust
  More Information

Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT01718925     History of Changes
Other Study ID Numbers: 3256 
Study First Received: October 29, 2012
Last Updated: October 14, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Fatigue
Irritable Bowel Syndrome
Inflammatory Bowel Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on December 05, 2016