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

December 10, 2013 updated by: Hospitalet Valdemar

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Ringsted, Denmark, 4100
        • Hospitalet Valdemar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 year +
  • can read and understand danish

Exclusion Criteria:

  • shellfish allergy
  • intake of anticoagulants and vitamin D
  • pacemaker
  • participating other studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: vegetable oil with betacarotene
4 capsules vegetable oil with betacarotene
Active Comparator: krill and vitamin D3
krill and vitamin D3. (72 mg), four capsules daily
Dietary supplement: Omega Krill with D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ADL function on a scale 0-11
Time Frame: february 2013-february 2014
february 2013-february 2014
pain on a scale 0-100 mm
Time Frame: february 2013-february 2014
february 2013-february 2014
Quality of life on a scale 0-100
Time Frame: february 2013-february 2014
february 2013-february 2014

Secondary Outcome Measures

Outcome Measure
Time Frame
compliance in %
Time Frame: february 2013-february 2014
february 2013-february 2014
changes at D3 levels
Time Frame: february 2013-february 2014
february 2013-february 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospitalet Valdemar

Investigators

  • Principal Investigator: Henrik Nielsen, C physician, Hospitalet Valdemar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

December 7, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SJ-327

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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