Irritable Bowel SyndromeNCT01718925
25-hydroxyvitamin D and Fatigue: The VITALITY Study
An observational study of Irritable Bowel Syndrome and Inflammatory Bowel Disease, run by Ostfold Hospital Trust.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Inflammatory Bowel Disease, Diabetes
- How many people
- 614 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- informed consent,
- over 18 years of age
Who cannot join
- dementia,
- cognitive disorders,
- not able to comply with the study procedures,
- on active vitamin D treatment
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Irritable Bowel Syndrome, Inflammatory Bowel Diseases, Diabetes Mellitus, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Fatigue and the impact of vitamin d levels
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostfold Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Aarhus University Hospital, Oslo University Hospital, Alesund Hospital, Helse Stavanger HF, Sykehuset Telemark, Sykehuset Innlandet HF, Ostfold University College
- Responsible party
- Sponsor
- Investigators
- Lars-Petter Jelsness-Jørgensen, PhD, Principal investigator, Ostfold Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718925
- Sponsor's protocol ID
- 3256
- Status last verified
- Oct 2015
- First submitted
- 29 Oct 2012
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D, Fatigue and Patient Reported Outcome (PRO) in Chronic Somatic and Functional Disorders.
- ClinicalTrials.gov ID
- NCT01718925
- Acronym / sponsor ID
- 3256
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Ostfold Hospital TrustUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Aarhus University Hospital, Oslo University Hospital, Alesund Hospital, Helse Stavanger HF, Sykehuset Telemark, Sykehuset Innlandet HF, Ostfold University College
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- informed consent,
- over 18 years of age
Key exclusion criteria (4 listed)
- dementia,
- cognitive disorders,
- not able to comply with the study procedures,
- on active vitamin D treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue
Time frame: 2 years
Fatigue and the impact of vitamin d levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars-Petter Jelsness-Jørgensen, PhD principal investigator
Ostfold Hospital Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome and Inflammatory Bowel Disease, run by Ostfold Hospital Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.