Clinical trial NCT00755482: Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee
Official title: Randomised, Placebo Controlled Trial to Examine the Effect of Aquamin F on NSAID Dose Reduction in Subjects With Osteoarthritis of the Knee.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
Clinical trial
Aquamin F
NSAID
Lead sponsor: Marigot Ltd.
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 29
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: WOMAC scores (pain, stiffness, mobility, total score)
measure: 6 minute walking distances
measure: Active and Passive range of motion (goniometer measurements)
measure: NSAID usage
measure: Rescue medication (acetaminophen) usage
Secondary outcomes:
measure: DXA scans for bone mineral density
measure: CRP levels
measure: Lipid profiles
measure: the safety/toxicology measurements including a chemistry profile (including serum calcium)
measure: complete blood counts
measure: adverse events
Other outcomes:
Locations:
city: Edina
country: United States
facility: Minnesota Applied Research Center
state: Minnesota
Study officials:
References:
citation: 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.
citation: Frestedt 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.