Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee

NCT ID: NCT00755482

Last Updated: 2008-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-09-30

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.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; Clinical trial; Aquamin F; NSAID

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Subjects were given Aquamin F

Group Type: ACTIVE_COMPARATOR

Aquamin F

Intervention Type: DRUG

2

Subjects were given a maltodextran placebo

Group Type: PLACEBO_COMPARATOR

Placebo (maltodextran)

Intervention Type: DRUG

Interventions

Aquamin F

Intervention Type: DRUG

Placebo (maltodextran)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marigot Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Marigot Ltd

Locations

Minnesota Applied Research Center

Edina, Minnesota, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18279523 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19187557 (View on PubMed)

Other Identifiers

MARC005-080

Identifier Type: -

Identifier Source: org_study_id