NCT02008760UnknownPhase 1
Survey of Chronic Pain Patients' Self-rated Quality of Life, ADL Function and Pain Before and After Intervention With Omega 3 Fatty Acids From Krill With Vitamin D3
Hospitalet Valdemar2 sites in 1 country55 target enrollmentStarted: February 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 55
- Locations
- 2
- Primary Endpoint
- ADL function on a scale 0-11
Study Overview
Brief Summary
The aim of this project is investigation of patients' with chronic pain self-rated quality of life, ADL function and level of pain before and after 3 months of intervention with N-3 fatty acids from krill in combination with vitamin D3. Furthermore, the compliance of the patients and the effect of the intervention on the patients' vitamin D status and cardiovascular risk factors are studied.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 year +
- •can read and understand danish
Exclusion Criteria
- •shellfish allergy
- •intake of anticoagulants and vitamin D
- •pacemaker
- •participating other studies
Outcomes
Primary Outcomes
ADL function on a scale 0-11
Time Frame: february 2013-february 2014
pain on a scale 0-100 mm
Time Frame: february 2013-february 2014
Quality of life on a scale 0-100
Time Frame: february 2013-february 2014
Secondary Outcomes
- compliance in %(february 2013-february 2014)
- changes at D3 levels(february 2013-february 2014)
Investigators
Study Sites (2)
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