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

NCT00755482 | Completed Phase 1

• 1 other identifier: MARC005-080
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Subjects were given Aquamin F

Drug: Aquamin F

2

PLACEBO COMPARATOR

Subjects were given a maltodextran placebo

Drug: Placebo (maltodextran)

Interventions

Aquamin F DRUG

1

Placebo (maltodextran) DRUG

2

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marigot Ltd.: lead

Study Sites (1)

Minnesota Applied Research Center

Edina, Minnesota, 55345, United States

Location

Related Publications (2)

• 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.

  PMID: 18279523 BACKGROUND

• 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.

  PMID: 19187557 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 18, 2008
• First Posted: September 19, 2008
• Study Start: January 1, 2006
• Study Completion: September 1, 2006
• Last Updated: September 19, 2008

Record last verified: 2008-09

Locations

US (1)