Effects of Aquamin F on Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Aquamin F
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Osteoarthritis, Clinical trial, Aquamin F, Glucosamine
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
WOMAC scores (pain, stiffness, mobility, total score)
6 Minute Walking Distances
Active and passive range of motion (goniometer measurements)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00452101
Brief Title
Effects of Aquamin F on Osteoarthritis of the Knee
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Marigot Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Osteoarthritis, Clinical trial, Aquamin F, Glucosamine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aquamin F
Primary Outcome Measure Information:
Title
WOMAC scores (pain, stiffness, mobility, total score)
Title
6 Minute Walking Distances
Title
Active and passive range of motion (goniometer measurements)
Secondary Outcome Measure Information:
Title
DXA scans for bone mineral density
Title
CRP levels
Title
Lipid profiles
Title
Rescue medication diary measurements
Title
The safety/toxicology measurements included a Chemistry Profile (including serum calcium)
Title
Complete Blood Counts
Title
Adverse Events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John L Zenk, MD
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
18279523
Citation
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.
Results Reference
derived
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Effects of Aquamin F on Osteoarthritis of the Knee
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