Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Subjects were given Aquamin F |
|
| 2 | Placebo Comparator | Subjects were given a maltodextran placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aquamin F | Drug |
| ||
| Placebo (maltodextran) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| DXA scans for bone mineral density | ||
| CRP levels | ||
| Lipid profiles |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minnesota Applied Research Center | Edina | Minnesota | 55345 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18279523 | Background | 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. | |
| 19187557 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| the safety/toxicology measurements including a chemistry profile (including serum calcium) |
| complete blood counts |
| adverse events |