25-hydroxyvitamin D and Fatigue: The VITALITY Study

Diabetes Clinical Trial

Official title:

Vitamin D, Fatigue and Patient Reported Outcome (PRO) in Chronic Somatic and Functional Disorders.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718925
• Other study ID #: 3256
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: October 14, 2015
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 614
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Diabetes
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	Aarhus University Hospital, Alesund Hospital, Helse Stavanger HF, Karolinska Institutet, Oslo University Hospital, Ostfold University College, Fredrikstad, Norway, Sykehuset Innlandet HF, Sykehuset Telemark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Fatigue and the impact of vitamin d levels	2 years	No