Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee
Phase 1
Completed
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Drug: Placebo (maltodextran)
- Registration Number
- NCT00755482
- Lead Sponsor
- Marigot Ltd.
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo (maltodextran) Subjects were given a maltodextran placebo 1 Aquamin F Subjects were given Aquamin F
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Minnesota Applied Research Center
🇺🇸Edina, Minnesota, United States