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

NCT01321281 | Completed Phase 2 DMC

• 1 other identifier: APC026-Marigot
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Cytokines

  Plasma cytokine concentrations (including TNFα, IL-β, NFκB, COX2 \& IL-6)

  Baseline (wk 0) & wk 6

Secondary Outcomes (3)

• WOMAC Questionnaire

  Wk0 & Wk6

• Full Blood Count

  Wk0 & Wk6

• Chemistry Profile

  Wk0 & Wk6

Study Arms (2)

AquaCal

EXPERIMENTAL

Osteoarthritis and healthy volunteers

Dietary Supplement: AquaCal

AquaPT

ACTIVE COMPARATOR

Osteoarthritis

Dietary Supplement: AquaPT

Interventions

AquaCal DIETARY_SUPPLEMENT

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).

AquaCal

AquaPT DIETARY_SUPPLEMENT

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.

AquaPT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrea Doolan: lead

Study Sites (1)

Cork University Hospital

Cork, Ireland

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Timothy Dinan

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Human Studies Manager

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 23, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

IE (1)