Effects of Aquamin F on Osteoarthritis of the Knee
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- WOMAC scores (pain, stiffness, mobility, total score)
- 6 Minute Walking Distances
- Active and passive range of motion (goniometer measurements)
- DXA scans for bone mineral density
- CRP levels
- Lipid profiles
- Rescue medication diary measurements
- The safety/toxicology measurements included a Chemistry Profile (including serum calcium)
- Complete Blood Counts
- Adverse Events
|Study Start Date:||January 2006|
|Study Completion Date:||December 2006|
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.