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

Phase 1

• Conditions: Pain; Quality of Life
• Interventions: Dietary Supplement: Omega Krill with D3

• Registration Number: NCT02008760
• Lead Sponsor: Hospitalet Valdemar

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-12
• Study First Submitted: 2013-12-07
• Study First Submitted QC: 2013-12-10
• Last Update Submitted: 2013-12-10
• Study First Posted: 2013-12-11
• Last Update Posted: 2013-12-11
• Primary Completion: 2014-03
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
krill and vitamin D3	Omega Krill with D3	krill and vitamin D3. (72 mg), four capsules daily

Primary Outcome Measures

Name	Time	Method
ADL function on a scale 0-11	february 2013-february 2014
pain on a scale 0-100 mm	february 2013-february 2014
Quality of life on a scale 0-100	february 2013-february 2014

Secondary Outcome Measures

Name	Time	Method
compliance in %	february 2013-february 2014
changes at D3 levels	february 2013-february 2014

Trial Locations

Locations (1)

Hospitalet Valdemar; 🇩🇰 Ringsted, Denmark