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Clinical Trials/NCT02008760
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

Sponsor
Hospitalet Valdemar
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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