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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

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

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

NCT ID

NCT00452101

First Posted

March 22, 2007

Last Updated

March 22, 2007

Sponsor

Marigot Ltd.

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

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

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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