Anemia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo Controlled Pilot Trial of Oral Salsalate in the Treatment of the Subset of Unexplained Anemia in Elderly Patients With Elevated Interleukin-6
The purpose of this study is to determine whether treatment of unexplained anemia in older adults and elevated inflammatory markers with oral salsalate can improve hemoglobin levels and improve physical activity and quality of life.
There is well-defined morbidity and mortality associated with anemia in the elderly and the
increasing proportion of elderly adults underscores the population's attributable risk of
anemia. As a potentially modifiable factor, an urgent need exists to delineate the impact of
anemia correction in the elderly. The Partnership for Anemia: Clinical and Translational
Trials in the Elderly (PACTTE) consortium has been created to focus on treatment strategies
for anemia in elderly patients. The data presented in this protocol provides a compelling
rationale to evaluate the impact of an anti-inflammatory (Salsalate) in older anemic adults
with elevated serum iL-6 levels.
Subjects will be 65 years or older adults with unexplained anemia and a elevated serum iL-6
≥ 1.0 pg/mL.
Subjects will receive 750mg of salsalate or matching placebo (one pill) twice a day (am and
pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a
day (am and pm) if the 750mg dose was tolerated for a further 5 months (for a total of 6
months)
The primary endpoint is to assess whether salsalate improves hemoglobin levels from baseline
to 6 month visit.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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