25-hydroxyvitamin D and Fatigue: The VITALITY Study

Completed

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

• Registration Number: NCT01718925
• Lead Sponsor: Ostfold Hospital Trust

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-01
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue	2 years	Fatigue and the impact of vitamin d levels