Recruiting
Phase 3

Galectin-3

Sponsor:

Massachusetts General Hospital

Code:

NCT02800629

Conditions

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Modified Citrus Pectin

Placebo

Study Details

Brief summary:

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.

Conditions

Osteoarthritis

Study ID

NCT02800629

Start date

Jul, 2016

Status verified date

Mar, 2018

Completion date

Jun, 2018

Anticipated

Primary completion date

May, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Modified Citrus Pectin

MCP versus placebo

Placebo

Primary outcome measure

  • WOMAC-Knee [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Yousif Hanna

6177267938

Ana Fernandes

6177267938

Locations

MGH

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Seth Brownmiller

617-726-7938

Ana Fernandes

6177267938

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 23, 2018

Last verified

Mar, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2018-03-23.