Knee Related Walking LimitationsPhase 4NCT01927848
Improving Gait in Persons With Knee Related Mobility Limitations by Rosenoids® Food Supplement: a Randomized Double-blind Placebo-controlled Trial
A Phase 4 study testing Rosehip in people with Knee Related Walking Limitations, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
Knee related mobility limitations are the leading cause of disability in the western world. It is a very expensive and debilitating condition when the cost of lost productivity and personal assistance is considered. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Related Walking Limitations
- What is being tested?
- Rosehip
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2013to Oct 2014
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged above 40
- Self-reported knee-related walking disability
- In general good health, in the opinion of the Investigator, based on medical history and physical examination and, if necessary, laboratory values. Laboratory tests are prescribed by the Investigator at the screening visit.
- A body mass index (BMI) of ≤35 kg/m2
- Speaks, reads and writes Danish language
Who cannot join
- Usage of Rosehip nutritional supplements within the last 3 months
- History of symptoms of autoimmune disorders.
- Planned surgical procedure during the duration of the study
- History, diagnosis, or signs and symptoms of clinically significant neurological disease
- Alcohol or drug abuse within the last 5 years
- History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
- Subjects with regional pain syndromes suggestive of lumbar compressions with radiculopathy or at risk of developing radiculopathy.
- Any other condition, which in the opinion of the Investigator, would put the subject at increased safety risk or otherwise make the subject unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Knee related mobility limitations are the leading cause of disability in the western world. It is a very expensive and debilitating condition when the cost of lost productivity and personal assistance is considered.
In recent years there has been a growing interest in alternative medicine and many individuals seek such treatments. Rosehip, that is sold as a nutritional supplement, has been particular popular, and has been shown effective in relieiving pain - albeit the evidence is scarce.
The purpose of this study is to evaluate the efficacy of specialized rosehip powder nutritional additives (Rosenoids®) on knee joint function during walking in subjects with knee-related walking limitations.
- Conditions
- Knee Related Walking Limitations
- Being tested
- Rosehip, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosehipDietary supplement
Rosehip powder made from the fleshy orange walls (hypanthiums) of Rosehips with the achenes (seeds) removed, from the wild growing species Dog Rose (Rosa canina L.), in addition to vitamin C as sodium ascorbate. The active ingredient complex is Rosenoids®, Vitamin C, flavonoids, carotens, triterpene acids, and galactolipids. Rosenoids® is the registered name for the bioactive complex isolated from the rose-hip (Rosa canina) used in RH01. It is being supplied as capsules containing 750 mg of the Rosehip powder and 26.7 mg vitamin C.
PlaceboDietary supplement
The placebo used in this study will be identical to the Rosehip capsules in both appearance and taste, except that it will not contain the active Rosehip powder ingredient Rosenoids® or vitamin C.
| Study group | Role | What they receive |
|---|---|---|
| Rosehip | Experimental | Dosage: 3 capsules once daily with meals (daily dose: 2.25 g powder). Receives: Dietary Supplement: Rosehip |
| Placebo | Placebo comparator | Dosage: 3 capsules once daily with meals Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee joint biomechanics during walking
3-D kinematic gait data is obtained using a 6-camera Motion Analysis System sampling at 100 Hz capturing positions and movements of reflective markers placed on the skin and arranged in the Plug-in-Gait configuration. Ground reaction forces and moments are obtained with two 6-channel force platforms (Advanced Mechanical Technologies, Inc., Newton, MA, USA) operating at 1500 Hz synchronized with the camera system. Specialized software is used to generate lower extremity angular kinematic and kinetic data using inverse dynamics.
Measured: 12 weeks
Secondary outcomes (7)
Circulating levels of C-reactive protein (blood samples)
Measured: 12 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
A questionnaire with suggestive leading questions, assessing adverse events at large - not necessarily adverse effects in a generic framework using options based on standards applied previously is used.
Measured: week 12
Physician global assessment of patient disease
Physician's global assessment of overall health at clinical visits is scored on a 100 mm visual analogue scale (VAS)
Measured: week 12
Self-reported status of the participants' knee and associated problems
Knee Osteoarthritis and Injury Outcome Score (KOOS)
Measured: week 12
Self-reported health and well-being
Self-reported questionnaire.
Measured: week 12
Circulating levels of Alanine AminoTransferase (blood samples)
Measured: 12 weeks
Circulating levels of Alkaline Phosphatase (blood samples)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee Related Walking LimitationsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Marius Henriksen, PhD, Principal investigator, Parker Institute, Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927848
- Sponsor's protocol ID
- 127
- Status last verified
- Jan 2015
- First submitted
- 16 Aug 2013
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ginnerup-Nielsen E, Christensen R, Bliddal H, Zangger G, Hansen L, Henriksen M. Improved gait in persons with knee related mobility limitations by a rosehip food supplement: A randomized, double-blind, placebo-controlled trial. Gait Posture. 2015 Sep;42(3):340-7. doi: 10.1016/j.gaitpost.2015.07.001. Epub 2015 Jul 19.
PubMed 26234471
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Gait in Persons With Knee Related Mobility Limitations by Rosenoids® Food Supplement: a Randomized Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01927848
- Acronym / sponsor ID
- 127
- Conditions
- Knee Related Walking Limitations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 23 Aug 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.
Knee related mobility limitations are the leading cause of disability in the western world. It is a very expensive and debilitating condition when the cost of lost productivity and personal assistance is considered.
In recent years there has been a growing interest in alternative medicine and many individuals seek such treatments. Rosehip, that is sold as a nutritional supplement, has been particular popular, and has been shown effective in relieiving pain - albeit the evidence is scarce.
The purpose of this study is to evaluate the efficacy of specialized rosehip powder nutritional additives (Rosenoids®) on knee joint function during walking in subjects with knee-related walking limitations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosehip | Experimental | Dietary Supplement: RosehipDosage: 3 capsules once daily with meals (daily dose: 2.25 g powder). |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDosage: 3 capsules once daily with meals |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged above 40
- Self-reported knee-related walking disability
- In general good health, in the opinion of the Investigator, based on medical history and physical examination and, if necessary, laboratory values. Laboratory tests are prescribed by the Investigator at the screening visit.
- A body mass index (BMI) of ≤35 kg/m2
- Speaks, reads and writes Danish language
Key exclusion criteria (8 listed)
- Usage of Rosehip nutritional supplements within the last 3 months
- History of symptoms of autoimmune disorders.
- Planned surgical procedure during the duration of the study
- History, diagnosis, or signs and symptoms of clinically significant neurological disease
- Alcohol or drug abuse within the last 5 years
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 |
|---|---|---|
| RosehipRosehip powder made from the fleshy orange walls (hypanthiums) of Rosehips with the achenes (seeds) removed, from the wild growing species Dog Rose (Rosa canina L.), in addition to vitamin C as sodium ascorbate. The active ingredient complex is Rosenoids®, Vitamin C, flavonoids, carotens, triterpene acids, and galactolipids. Rosenoids® is the registered name for the bioactive complex isolated from the rose-hip (Rosa canina) used in RH01. It is being supplied as capsules containing 750 mg of the Rosehip powder and 26.7 mg vitamin C. | Dietary supplement | Rosehip |
| PlaceboThe placebo used in this study will be identical to the Rosehip capsules in both appearance and taste, except that it will not contain the active Rosehip powder ingredient Rosenoids® or vitamin C. | Dietary supplement | Placebo |
Primary outcome
Knee joint biomechanics during walking
Time frame: 12 weeks
3-D kinematic gait data is obtained using a 6-camera Motion Analysis System sampling at 100 Hz capturing positions and movements of reflective markers placed on the skin and arranged in the Plug-in-Gait configuration. Ground reaction forces and moments are obtained with two 6-channel force platforms (Advanced Mechanical Technologies, Inc., Newton, MA, USA) operating at 1500 Hz synchronized with the camera system. Specialized software is used to generate lower extremity angular kinematic and kinetic data using inverse dynamics.
7 secondary outcomes
Circulating levels of C-reactive protein (blood samples)
Time frame: 12 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: week 12
Physician global assessment of patient disease
Time frame: week 12
Self-reported status of the participants' knee and associated problems
Time frame: week 12
Self-reported health and well-being
Time frame: week 12
Circulating levels of Alanine AminoTransferase (blood samples)
Time frame: 12 weeks
Circulating levels of Alkaline Phosphatase (blood samples)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
- Derived from this study: PubMed 26234471Ginnerup-Nielsen E, Christensen R, Bliddal H, Zangger G, Hansen L, Henriksen M. Improved gait in persons with knee related mobility limitations by a rosehip food supplement: A randomized, double-blind, placebo-controlled trial. Gait Posture. 2015 Sep;42(3):340-7. doi: 10.1016/j.gaitpost.2015.07.001. Epub 2015 Jul 19.
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.
Marius Henriksen, PhD principal investigator
Parker Institute, Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosehip in people with Knee Related Walking Limitations, run by Frederiksberg University Hospital 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 15 Jan 2015. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee joint biomechanics during walking (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01927848, which also lists 1 linked publication.
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 15 Jan 2015.