NCT00452101

Effects of Aquamin F on Osteoarthritis of the Knee

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (planned)
• Sponsor: Marigot Ltd. · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Aquamin F

Timeline

• Start date: 2006-01-01
• Completion: 2006-12-01
• First posted: 2007-03-26
• Last updated: 2007-03-26