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

Osteoarthritis of the Knee Clinical Trial

Official title:

Randomised, Placebo Controlled Trial to Examine the Effect of Aquamin F on NSAID Dose Reduction in Subjects With Osteoarthritis of the Knee.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00755482
• Other study ID #: MARC005-080
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 18, 2008
• Last updated: September 18, 2008
• Start date: January 2006
• Est. completion date: September 2006

Study information

• Verified date: September 2008
• Source: Marigot Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Aquamin F

• Placebo (maltodextran)

Locations

Country	Name	City	State
United States	Minnesota Applied Research Center	Edina	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Marigot Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC scores (pain, stiffness, mobility, total score)
Primary	6 minute walking distances
Primary	Active and Passive range of motion (goniometer measurements)
Primary	NSAID usage
Primary	Rescue medication (acetaminophen) usage
Secondary	DXA scans for bone mineral density
Secondary	CRP levels
Secondary	Lipid profiles
Secondary	the safety/toxicology measurements including a chemistry profile (including serum calcium)
Secondary	complete blood counts
Secondary	adverse events