Purpose

The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3 inhibition with MCP to placebo for the treatment of knee osteoarthritis.

Condition

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Knee pain in at least one knee for more than half the days in the month prior to screening 2. X-rays showing evidence of knee osteoarthritis by Kellgren and Lawrence Score two or three, with definite osteophytes and possible or definite joint space narrowing, consistent with mild to moderate knee osteoarthritis. If both knees are affected, patients would choose the more severe knee for outcomes assessments. 3. Willingness to maintain stable analgesic regimen throughout the study period

Exclusion Criteria

  1. Diagnosis of fibromyalgia 2. Presence of an underlying inflammatory disease in the affected knee, including Rheumatoid Arthritis, Psoriatic Arthritis, Gout, Pseudogout, or other inflammatory disease. 3. Patients who cannot give consent will be excluded, as will patients who cannot speak, read and understand English, as we will not have translated documents, consent forms, and surveys for them. 4. While this supplement is considered very safe and low risk, patients with underlying significant cytopenia (white blood cell count less than 4.0, hemoglobin less than 10, or platelets less than 100), or with impaired renal function (glomerular filtration rate less than 60) or elevated liver enzymes will be excluded as well.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, double blind clinical trial
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Intervention
Patients will be given Modified Citrus Pectin twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed
  • Dietary Supplement: Modified Citrus Pectin
    MCP versus placebo
Placebo Comparator
Control
Patients will be given placebo twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed
  • Dietary Supplement: Placebo

Recruiting Locations

MGH
Boston, Massachusetts 02114
Contact:
Seth Brownmiller
617-726-7938

More Details

Status
Unknown status
Sponsor
Massachusetts General Hospital

Study Contact

Yousif Hanna
6177267938

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.