Osteoarthritis of the KneePhase 1/2NCT00452101
Effects of Aquamin F on Osteoarthritis of the Knee
A Phase 1/2 study testing Aquamin F in people with Osteoarthritis of the Knee, run by Marigot Ltd..
Trial summary
The objective of this trial is to evaluate the effect of Aquamin F alone or in combination with glucosamine sulfate versus placebo on symptoms of joint pain, stiffness and immobility in subjects with painful 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
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 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 Rheumatology17, 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 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.
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- Subjects whose schedules permit clinic evaluations every four weeks.
- Subjects who are willing to stop taking calcium supplements, if any, and to restrict consumption of high calcium foods to 600 mg (two dairy serving) 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 unauthorized 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 suffering from 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:
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- Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) within 48 hours prior to study enrollment.
- Intramuscular or systemic corticosteroid injection within 4 weeks prior to study enrollment.
- Intra-articular corticosteroid injection within 2 months prior to study enrollment.
- Intra-articular hyaluronic acid injection within 4 months prior to study enrollment.
About this study
Official title: Randomized, Placebo Controlled Trial: Effects of Aquamin F Alone or in Combination With Glucosamine Sulfate on Joint Mobility and Pain in Osteoarthritis of the Knee
The objective of this trial is to evaluate the effect of Aquamin F alone or in combination with glucosamine sulfate versus placebo on symptoms of joint pain, stiffness and immobility in subjects with painful osteoarthritis of the knee. The following hypotheses were tested:
(Hypothesis 1) After 12 weeks of treatment, subjects taking Aquamin F alone or in combination with glucosamine sulfate will have significantly less joint pain, stiffness and immobility compared to subjects taking glucosamine sulfate alone or placebo alone.
(Hypothesis 2) No significant differences will be seen for adverse events between the subjects taking Aquamin F, glucosamine sulfate, Aquamin F + glucosamine sulfate or placebo.
Read the detailed description
Method: Subjects were randomized to receive 12 weeks of Glucosamine sulfate vs Aquamin F vs Placebo vs Aquamin F + Glucosamine sulfate while controlling for pain with acetaminophen. Subjects were then followed for blood chemistry measurements only over an additional 12-week period specifically to assess blood calcium levels post treatment. All participants were subjected to the same diet and exercise regimen and measurements included: WOMAC scores (pain, stiffness, mobility, total score), 6 Minute Walking Distances, active and passive range of motion measurements, DXA scans, blood chemistry, hematology, CRP levels and lipid profiles as well as rescue medication diary measurements and adverse event assessments. An independent statistician analyzed the data using independent t-tests and ANCOVA for between-group comparisons and matched-pair t-tests for within-group comparisons of patients included in ITT-LOCF and completer analyses.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Aquamin F
- Keywords
- Osteoarthritis, Clinical trial, Aquamin F, Glucosamine
- 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
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)
Secondary outcomes (7)
DXA scans for bone mineral density
CRP levels
Lipid profiles
Rescue medication diary measurements
The safety/toxicology measurements included 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 posted26 Mar 2007 (estimated)
- Study startJan 2006
- Study completionDec 2006
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 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
- 70 participants
Sponsor and investigators
- Lead sponsor
- Marigot Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John L Zenk, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452101
- Sponsor's protocol ID
- MARC005-065
- Status last verified
- Mar 2007
- First submitted
- 22 Mar 2007
- Last updated
- 26 Mar 2007
- 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 18279523
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo Controlled Trial: Effects of Aquamin F Alone or in Combination With Glucosamine Sulfate on Joint Mobility and Pain in Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00452101
- Acronym / sponsor ID
- MARC005-065
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, Clinical trial, Aquamin F, Glucosamine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Marigot Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 26 Mar 2007 (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 alone or in combination with glucosamine sulfate versus placebo on symptoms of joint pain, stiffness and immobility in subjects with painful osteoarthritis of the knee. The following hypotheses were tested:
(Hypothesis 1) After 12 weeks of treatment, subjects taking Aquamin F alone or in combination with glucosamine sulfate will have significantly less joint pain, stiffness and immobility compared to subjects taking glucosamine sulfate alone or placebo alone.
(Hypothesis 2) No significant differences will be seen for adverse events between the subjects taking Aquamin F, glucosamine sulfate, Aquamin F + glucosamine sulfate or placebo.
Detailed description
Method: Subjects were randomized to receive 12 weeks of Glucosamine sulfate vs Aquamin F vs Placebo vs Aquamin F + Glucosamine sulfate while controlling for pain with acetaminophen. Subjects were then followed for blood chemistry measurements only over an additional 12-week period specifically to assess blood calcium levels post treatment. All participants were subjected to the same diet and exercise regimen and measurements included: WOMAC scores (pain, stiffness, mobility, total score), 6 Minute Walking Distances, active and passive range of motion measurements, DXA scans, blood chemistry, hematology, CRP levels and lipid profiles as well as rescue medication diary measurements and adverse event assessments. An independent statistician analyzed the data using independent t-tests and ANCOVA for between-group comparisons and matched-pair t-tests for within-group comparisons of patients included in ITT-LOCF and completer analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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 Rheumatology17, 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 with screening WOMAC Osteoarthritis Index total score (transformed score) of not more than 75.
Key exclusion criteria (10 listed)
- Subjects suffering from 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 | – |
Primary outcome
WOMAC scores (pain, stiffness, mobility, total score)
6 Minute Walking Distances
Active and passive range of motion (goniometer measurements)
7 secondary outcomes
DXA scans for bone mineral density
CRP levels
Lipid profiles
Rescue medication diary measurements
The safety/toxicology measurements included 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 26 Mar 2007.
- Derived from this study: 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.
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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.
John L Zenk, MD study chair
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..
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 12 inclusion and 10 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 26 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 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?
On the ClinicalTrials.gov record for NCT00452101, 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 26 Mar 2007.