Effects of Aquamin F on Osteoarthritis of the Knee

March 22, 2007 updated by: Marigot Ltd.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

70

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
WOMAC scores (pain, stiffness, mobility, total score)
6 Minute Walking Distances
Active and passive range of motion (goniometer measurements)

Secondary Outcome Measures

Outcome Measure
Adverse Events
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marigot Ltd.

Investigators

  • Study Chair: John L Zenk, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

March 22, 2007

First Submitted That Met QC Criteria

March 22, 2007

First Posted (Estimate)

March 26, 2007

Study Record Updates

Last Update Posted (Estimate)

March 26, 2007

Last Update Submitted That Met QC Criteria

March 22, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARC005-065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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