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Completed

NCT Number: NCT01718925

25-hydroxyvitamin D and Fatigue: The VITALITY Study

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.

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Key information

Conditions

Irritable Bowel Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Colonic Diseases Colonic Diseases, Functional Connective Tissue Diseases Diabetes Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Gastroenteritis Gastrointestinal Diseases Glucose Metabolism Disorders Immune System Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fatigue

    Time frame: 2 years

    Fatigue and the impact of vitamin d levels

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 1, 2012
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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