Quality of LifePhase 1NCT02008760
QOL, ADL and Pain Before and After Intervention With N3 From Krill With D3.
A Phase 1 study testing Omega Krill with D3 in people with Quality of Life and Pain, run by Hospitalet Valdemar at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Pain
- What is being tested?
- Omega Krill with D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 year +
- can read and understand danish
Who cannot join
- shellfish allergy
- intake of anticoagulants and vitamin D
- pacemaker
- participating other studies
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Quality of Life, Pain
- Being tested
- Omega Krill with D3
- Keywords
- pain, quality of life, ADL, DOLO test, compliance, D3
- Medical subject headings
- Pain, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega Krill with D3Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Omega Krill with D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADL function on a scale 0-11
Measured: february 2013-february 2014
pain on a scale 0-100 mm
Measured: february 2013-february 2014
Quality of life on a scale 0-100
Measured: february 2013-february 2014
Secondary outcomes (2)
compliance in %
Measured: february 2013-february 2014
changes at D3 levels
Measured: february 2013-february 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospitalet Valdemar
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henrik Nielsen, C physician, Principal investigator, Hospitalet Valdemar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008760
- Sponsor's protocol ID
- SJ-327
- Status last verified
- Dec 2013
- First submitted
- 7 Dec 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02008760
- Acronym / sponsor ID
- SJ-327
- Conditions
- Quality of Life, Pain
- Keywords
- pain, quality of life, ADL, DOLO test, compliance, D3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hospitalet ValdemarIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vegetable oil with betacarotene | Placebo comparator | –4 capsules vegetable oil with betacarotene |
| krill and vitamin D3 | Active comparator | Dietary Supplement: Omega Krill with D3krill and vitamin D3. (72 mg), four capsules daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 year +
- can read and understand danish
Key exclusion criteria (4 listed)
- shellfish allergy
- intake of anticoagulants and vitamin D
- pacemaker
- participating other studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega Krill with D3 | Dietary supplement | krill and vitamin D3 |
Primary outcome
ADL function on a scale 0-11
Time frame: february 2013-february 2014
pain on a scale 0-100 mm
Time frame: february 2013-february 2014
Quality of life on a scale 0-100
Time frame: february 2013-february 2014
2 secondary outcomes
compliance in %
Time frame: february 2013-february 2014
changes at D3 levels
Time frame: february 2013-february 2014
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Nielsen, C physician principal investigator
Hospitalet Valdemar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omega Krill with D3 in people with Quality of Life and Pain, run by Hospitalet Valdemar at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADL function on a scale 0-11 (time frame: february 2013-february 2014). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.