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A Study to Determine if Aquamin Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01321281
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Andrea Doolan, University College Cork

Brief Summary:

Osteoarthritis (OA) is the most common kind of arthritis and primarily affects the large, weight bearing joints (including the knees, lower back, hips, neck and the feet) and the joints in the hands. OA results from the breakdown of cartilage in joints, leading to joint pain and damage. It affects about 8 million people in the United Kingdom and nearly 27 million people in the United States, most of whom are over the age of 45.

This study aim to determine if Aquamin (as AquaCal and AquaPT) affects molecules of inflammation in the blood of osteoarthritis and healthy subjects.

Condition or disease Intervention/treatment Phase
Osteoarthritis Dietary Supplement: AquaCal Dietary Supplement: AquaPT Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Randomised, Placebo Controlled Study to Determine if Aquamin (as AquaCal and AquaPT) Modulates Inflammatory Biomarkers in the Blood of Osteoarthritis and Healthy Subjects
Study Start Date : March 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: AquaCal
Osteoarthritis and healthy volunteers
Dietary Supplement: AquaCal

AquaCal and AquaPT are produced by Marigot Ltd according to EU and FDA requirements.

The daily dose of 4 capsules of AquaCal provide 800mg calcium, (the EU RDA for calcium) and 74 mgs Magnesium (EU RDA 375mg).

Active Comparator: AquaPT
Dietary Supplement: AquaPT

AquaCal and AquaPT are produced by Marigot Ltd according to EU and FDA requirements.

The daily dose of 4 capsules of AquaPT provides 720mg calcium, 200mgs green tea (polyphenols) and 50 mgs pine bark extract.

Primary Outcome Measures :
  1. Cytokines [ Time Frame: Baseline (wk 0) & wk 6 ]
    Plasma cytokine concentrations (including TNFα, IL-β, NFκB, COX2 & IL-6)

Secondary Outcome Measures :
  1. WOMAC Questionnaire [ Time Frame: Wk0 & Wk6 ]
    Western Ontario and McMaster Universities Arthritis Index

  2. Full Blood Count [ Time Frame: Wk0 & Wk6 ]
    Haemaglobin, white cell count, platelet count, haematocrit, differential white count

  3. Chemistry Profile [ Time Frame: Wk0 & Wk6 ]
    Including Sodium, Potassium, Chloride, Urea, Creatinine, Protein, Albumin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

To be considered eligible for enrollment into the study, subjects must;

  • Be able to give written informed consent.
  • Be female and between 18 and 65 years of age.
  • Be a non-pregnant female.
  • Be in generally good health as determined by the investigator.
  • Osteoarthritis patients must have a clinical diagnosis of moderate to severe osteoarthritis.

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the below criteria;

  • Are less than 18 and greater than 65 years of age.
  • Are pregnant females.
  • Are currently taking probiotics or vitamin supplements, or have taken them in the past 14 days.
  • Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic or any condition which contraindicates, in the investigators judgment, entry to the study).
  • Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include non-steroidal anti-inflammatory drugs (NSAIDs), steroids and vitamin.
  • Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
  • Subjects may not be receiving treatment involving experimental drugs.
  • If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
  • Have a malignant disease or any concomitant end-stage organ disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01321281

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Cork University Hospital
Cork, Ireland
Sponsors and Collaborators
Andrea Doolan
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Principal Investigator: Timothy Dinan University College Cork
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Responsible Party: Andrea Doolan, Human Studies Manager, University College Cork Identifier: NCT01321281    
Other Study ID Numbers: APC026-Marigot
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Keywords provided by Andrea Doolan, University College Cork:
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases