NCT02008760

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P75+ for phase_1 quality-of-life

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

1.1 years

First QC Date

December 7, 2013

Last Update Submit

December 10, 2013

Conditions

Quality of LifePain

Keywords

painquality of lifeADLDOLO testcomplianceD3

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • compliance in %

    february 2013-february 2014

  • changes at D3 levels

    february 2013-february 2014

Study Arms (2)

vegetable oil with betacarotene

PLACEBO COMPARATOR

4 capsules vegetable oil with betacarotene

krill and vitamin D3

ACTIVE COMPARATOR

krill and vitamin D3. (72 mg), four capsules daily

Dietary Supplement: Omega Krill with D3

Interventions

Omega Krill with D3DIETARY_SUPPLEMENT
krill and vitamin D3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year +
  • can read and understand danish

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospitalet Valdemar

Ringsted, 4100, Denmark

Location

MeSH Terms

Conditions

PainPatient Compliance

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Henrik Nielsen, C physician

    Hospitalet Valdemar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2013

First Posted

December 11, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

DK(1)