Blocking Extracellular Galectin-3 in Patients With Osteoarthritis

Mass General Brigham

Status and phase: Unknown; Phase 3

Conditions: Osteoarthritis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Modified Citrus Pectin

Study type: Interventional

Funder types: Other

Identifiers

NCT02800629

2016P001077

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Modified Citrus Pectin

Control

Placebo Comparator group

Description:

Patients will be given placebo twice daily for 12 weeks, and have their change in knee pain as measured by survey instruments assessed

Treatment:

Dietary Supplement: Placebo