25-hydroxyvitamin D and Fatigue: The VITALITY Study

NCT01718925 | Completed

• 1 other identifier: 3256
• Study Type: observational
• Target: 614
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Disease; Diabetes; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Fatigue and the impact of vitamin d levels

  2 years

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• informed consent,
• over 18 years of age

You may not qualify if:

• dementia,
• cognitive disorders,
• not able to comply with the study procedures,
• on active vitamin D treatment

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Karolinska Institutet: collaborator
• Aarhus University Hospital: collaborator
• Oslo University Hospital: collaborator
• Alesund Hospital: collaborator
• Helse Stavanger HF: collaborator
• Sykehuset Telemark: collaborator
• Sykehuset Innlandet HF: collaborator
• Ostfold University College: collaborator

MeSH Terms

Conditions

Irritable Bowel Syndrome; Inflammatory Bowel Diseases; Diabetes Mellitus; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lars-Petter Jelsness-Jørgensen, PhD

  Ostfold Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 1, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 15, 2015

Record last verified: 2015-10