QOL, ADL and Pain Before and After Intervention With N3 From Krill With D3.

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02008760
• Other study ID #: SJ-327
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: December 7, 2013
• Last updated: December 10, 2013
• Start date: February 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2013
• Source: Hospitalet Valdemar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 55
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 year +

• can read and understand danish

Exclusion Criteria:

• shellfish allergy

• intake of anticoagulants and vitamin D

• pacemaker

• participating other studies

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Quality of Life

Intervention

Dietary Supplement:
• Omega Krill with D3

Locations

Country	Name	City	State
Denmark	Hospitalet Valdemar	Ringsted

Sponsors (1)

Lead Sponsor	Collaborator
Hospitalet Valdemar

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADL function on a scale 0-11		february 2013-february 2014	No
Primary	pain on a scale 0-100 mm		february 2013-february 2014	No
Primary	Quality of life on a scale 0-100		february 2013-february 2014	No
Secondary	compliance in %		february 2013-february 2014	No
Secondary	changes at D3 levels		february 2013-february 2014	No