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Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)

NCT01201759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-06-10

Study results available
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Summary

The overall study objectives are to examine whether:

1. Persons with spinal cord injury (SCI) having elevated body mass are at greater cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and vascular inflammation than persons with SCI having 'normal' body mass, and
2. An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.

Conditions

  • Spinal Cord Injury

Interventions

DRUG

Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days

Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2

DRUG

Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.

Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Mark S Nash, PhD · University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01201759 on ClinicalTrials.gov