Effects of Aquamin F on Osteoarthritis of the Knee

Osteoarthritis of the Knee Clinical Trial

Official title:

Randomized, Placebo Controlled Trial: Effects of Aquamin F Alone or in Combination With Glucosamine Sulfate on Joint Mobility and Pain in Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452101
• Other study ID #: MARC005-065
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 22, 2007
• Last updated: March 22, 2007
• Start date: January 2006
• Est. completion date: December 2006

Study information

• Verified date: March 2007
• 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 alone or in combination with glucosamine sulfate versus placebo on symptoms of joint pain, stiffness and immobility in subjects with painful osteoarthritis of the knee. The following hypotheses were tested:

(Hypothesis 1) After 12 weeks of treatment, subjects taking Aquamin F alone or in combination with glucosamine sulfate will have significantly less joint pain, stiffness and immobility compared to subjects taking glucosamine sulfate alone or placebo alone.

(Hypothesis 2) No significant differences will be seen for adverse events between the subjects taking Aquamin F, glucosamine sulfate, Aquamin F + glucosamine sulfate or placebo.

Description:

Method: Subjects were randomized to receive 12 weeks of Glucosamine sulfate vs Aquamin F vs Placebo vs Aquamin F + Glucosamine sulfate while controlling for pain with acetaminophen. Subjects were then followed for blood chemistry measurements only over an additional 12-week period specifically to assess blood calcium levels post treatment. All participants were subjected to the same diet and exercise regimen and measurements included: WOMAC scores (pain, stiffness, mobility, total score), 6 Minute Walking Distances, active and passive range of motion measurements, DXA scans, blood chemistry, hematology, CRP levels and lipid profiles as well as rescue medication diary measurements and adverse event assessments. An independent statistician analyzed the data using independent t-tests and ANCOVA for between-group comparisons and matched-pair t-tests for within-group comparisons of patients included in ITT-LOCF and completer analyses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 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 Rheumatology17, 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 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 clinic evaluations every four weeks.

• Subjects who are willing to stop taking calcium supplements, if any, and to restrict consumption of high calcium foods to 600 mg (two dairy serving) 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 unauthorized supplements or participating in any other clinical trial or experimental treatment during this trial

• Subjects with normal gastrointestinal digestion and absorption.

Exclusion Criteria

• Subjects suffering from 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:

• Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) within 48 hours prior to study enrollment.

• Intramuscular or systemic corticosteroid injection within 4 weeks prior to study enrollment.

• Intra-articular corticosteroid injection within 2 months prior to study enrollment.

• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marigot Ltd.

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)
Secondary	DXA scans for bone mineral density
Secondary	CRP levels
Secondary	Lipid profiles
Secondary	Rescue medication diary measurements
Secondary	The safety/toxicology measurements included a Chemistry Profile (including serum calcium)
Secondary	Complete Blood Counts
Secondary	Adverse Events