Osteoarthritis of the KneePhase 1/2NCT00755482
Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee
A Phase 1/2 study testing Aquamin F in people with Osteoarthritis of the Knee, run by Marigot Ltd. at 1 site in United States.
Trial summary
The objective of this trial is to evaluate the effect of Aquamin F versus placebo on NSAID (non-steroidal anti-inflammatory drug) dose reduction in subjects with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Aquamin F
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2006
- Phase
- Phase 1/2
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 35 to 75, male or female
- Subjects diagnosed with symptomatic moderate to severe osteoarthritis of the knee according to the modified criteria of the American College of Rheumatology 17,18
- Subjects who present with osteoarthritis of the knee as judged by symptoms and disabilities detectable through published, validated questionnaires or previous diagnosis by a physician
- subjects who are symptomatic with daily or near daily pain and stiffness from osteoarthritis
- subjects who are taking non-steroidal anti-inflammatory drugs (NSAIDs) prior to study enrollment
- subjects who are willing to stop NSAIDS and use acetaminophen for pain management during the trial
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- subjects with screening WOMAC osteoarthritis index total score (transformed score) of not more than 75
- subjects with ability to comprehend and complete the questionnaires and forms
- subjects whose schedules permit clinical evaluations every four weeks
- subjects who are willing to stop taking calcium supplements, if any and to restrict consumption of high calcium food to 600mg (two dairy servings) per day
- subjects with a high probability of compliance with study procedures and test article consumption
- subjects willing and able to follow protocol guidelines and schedules and complete diaries
- subjects who are likely to abstain from taking unathorized supplements or participating in any other clinical trial or experimental treatment during this trial
- subjects with normal gastrointestinal digestion and absorption
Who cannot join
- subjects who have a history of inflammatory arthritis, gout, pseudogout, Paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or HIV infection
- subjects who are non-ambulatory or bedridden due to osteoarthritis
- subjects who are dependent on prescription drugs to control pain
- subjects on any other clinical trial or experimental treatment in the past 3 months
- subjects who are pregnant, lactating or at risk of becoming pregnant
- subjects who have received : intramuscular corticosteroid injection or systemic corticosteroid administration within 4 weeks prior to study enrollment, intra-articular corticosteroid injection within 2 months prior to study enrollment or intra-articular hyaluronic acid injection within 4 months prior to study enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Minnesota Applied Research Center
Edina, Minnesota, 55345
About this study
Official title: Randomised, Placebo Controlled Trial to Examine the Effect of Aquamin F on NSAID Dose Reduction in Subjects With Osteoarthritis of the Knee.
The objective of this trial is to evaluate the effect of Aquamin F versus placebo on NSAID (non-steroidal anti-inflammatory drug) dose reduction in subjects with osteoarthritis of the knee.
Hypothesis 1: After 12 weeks of treatment, subjects taking Aquamin F will use significantly less NSAID medications for symptoms of osteoarthritis versus placebo alone.
Hypothesis 2: No significant differences will be seen for adverse events between the subjects taking Aquamin F or placebo.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Aquamin F, Placebo (maltodextran)
- Keywords
- Osteoarthritis, Clinical trial, Aquamin F, NSAID
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquamin FDrug
Placebo (maltodextran)Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subjects were given Aquamin F Receives: Drug: Aquamin F |
| 2 | Placebo comparator | Subjects were given a maltodextran placebo Receives: Drug: Placebo (maltodextran) |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC scores (pain, stiffness, mobility, total score)
6 minute walking distances
Active and Passive range of motion (goniometer measurements)
NSAID usage
Rescue medication (acetaminophen) usage
Secondary outcomes (6)
DXA scans for bone mineral density
CRP levels
Lipid profiles
the safety/toxicology measurements including a chemistry profile (including serum calcium)
complete blood counts
adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startJan 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the KneeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marigot Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755482
- Sponsor's protocol ID
- MARC005-080
- Status last verified
- Sep 2008
- First submitted
- 18 Sep 2008
- Last updated
- 19 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Frestedt JL, Walsh M, Kuskowski MA, Zenk JL. A natural mineral supplement provides relief from knee osteoarthritis symptoms: a randomized controlled pilot trial. Nutr J. 2008 Feb 17;7:9. doi: 10.1186/1475-2891-7-9.
PubMed 18279523Frestedt JL, Kuskowski MA, Zenk JL. A natural seaweed derived mineral supplement (Aquamin F) for knee osteoarthritis: a randomised, placebo controlled pilot study. Nutr J. 2009 Feb 2;8:7. doi: 10.1186/1475-2891-8-7.
PubMed 19187557
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Placebo Controlled Trial to Examine the Effect of Aquamin F on NSAID Dose Reduction in Subjects With Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT00755482
- Acronym / sponsor ID
- MARC005-080
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, Clinical trial, Aquamin F, NSAID
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Marigot Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Sep 2006 (actual)
- First posted
- 19 Sep 2008 (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 objective of this trial is to evaluate the effect of Aquamin F versus placebo on NSAID (non-steroidal anti-inflammatory drug) dose reduction in subjects with osteoarthritis of the knee.
Hypothesis 1: After 12 weeks of treatment, subjects taking Aquamin F will use significantly less NSAID medications for symptoms of osteoarthritis versus placebo alone.
Hypothesis 2: No significant differences will be seen for adverse events between the subjects taking Aquamin F or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Aquamin FSubjects were given Aquamin F |
| 2 | Placebo comparator | Drug: Placebo (maltodextran)Subjects were given a maltodextran placebo |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects aged 35 to 75, male or female
- Subjects diagnosed with symptomatic moderate to severe osteoarthritis of the knee according to the modified criteria of the American College of Rheumatology 17,18
- Subjects who present with osteoarthritis of the knee as judged by symptoms and disabilities detectable through published, validated questionnaires or previous diagnosis by a physician
- subjects who are symptomatic with daily or near daily pain and stiffness from osteoarthritis
- subjects who are taking non-steroidal anti-inflammatory drugs (NSAIDs) prior to study enrollment
Key exclusion criteria (6 listed)
- subjects who have a history of inflammatory arthritis, gout, pseudogout, Paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or HIV infection
- subjects who are non-ambulatory or bedridden due to osteoarthritis
- subjects who are dependent on prescription drugs to control pain
- subjects on any other clinical trial or experimental treatment in the past 3 months
- subjects who are pregnant, lactating or at risk of becoming pregnant
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 |
|---|---|---|
| Aquamin F | Drug | 1 |
| Placebo (maltodextran) | Drug | 2 |
Primary outcome
WOMAC scores (pain, stiffness, mobility, total score)
6 minute walking distances
Active and Passive range of motion (goniometer measurements)
NSAID usage
Rescue medication (acetaminophen) usage
6 secondary outcomes
DXA scans for bone mineral density
CRP levels
Lipid profiles
the safety/toxicology measurements including a chemistry profile (including serum calcium)
complete blood counts
adverse events
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 19 Sep 2008.
- Background: PubMed 18279523Frestedt JL, Walsh M, Kuskowski MA, Zenk JL. A natural mineral supplement provides relief from knee osteoarthritis symptoms: a randomized controlled pilot trial. Nutr J. 2008 Feb 17;7:9. doi: 10.1186/1475-2891-7-9.
- Derived from this study: PubMed 19187557Frestedt JL, Kuskowski MA, Zenk JL. A natural seaweed derived mineral supplement (Aquamin F) for knee osteoarthritis: a randomised, placebo controlled pilot study. Nutr J. 2009 Feb 2;8:7. doi: 10.1186/1475-2891-8-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Aquamin F in people with Osteoarthritis of the Knee, run by Marigot Ltd. at 1 site in United States.
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 14 inclusion and 6 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 19 Sep 2008. 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 United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
WOMAC scores (pain, stiffness, mobility, total score). The study lists 5 primary outcomes in all. 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 NCT00755482, which also lists 2 linked publications.
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 19 Sep 2008.