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

NCT ID: NCT02008760

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Quality of Life Pain

Keywords

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pain quality of life ADL DOLO test compliance D3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vegetable oil with betacarotene

4 capsules vegetable oil with betacarotene

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

krill and vitamin D3

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

Group Type ACTIVE_COMPARATOR

Omega Krill with D3

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Omega Krill with D3

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 18 year +
* can read and understand danish

Exclusion Criteria

* shellfish allergy
* intake of anticoagulants and vitamin D
* pacemaker
* participating other studies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospitalet Valdemar

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henrik Nielsen, C physician

Role: PRINCIPAL_INVESTIGATOR

Hospitalet Valdemar

Locations

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Hospitalet Valdemar

Ringsted, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SJ-327

Identifier Type: -

Identifier Source: org_study_id