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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Rheumatoid Arthritis; Irritable Bowel Syndrome; Inflammatory Bowel Disease

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.

• Study Type: Observational
• Enrollment (Actual): 614

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Fatigue and the impact of vitamin d levels	2 years

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: Karolinska Institutet; Oslo University Hospital; Aarhus University Hospital; Helse Stavanger HF; Sykehuset Innlandet HF; Alesund Hospital; Sykehuset Telemark; Ostfold University College
• Investigators: Principal Investigator: Lars-Petter Jelsness-Jørgensen, PhD, Ostfold Hospital Trust

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Estimate): October 15, 2015
• Last Update Submitted That Met QC Criteria: October 14, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome; Inflammatory Bowel Diseases
• Other Study ID Numbers: 3256