Sickle Cell Disease Clinical Trial
Official title:
N-Acetylcysteine in Patients With Sickle Cell Disease - Reducing the Incidence of Daily Life Pain
The primary aim of this study is to evaluate the effect of the drug N-Acetylcysteine on the
frequency of pain in daily life in patients with Sickle Cell Disease (SCD).
Pain is an invalidating hallmark of this disease and has a considerable impact on the
Quality of Life of patients and the medical health care system. Oxidative stress is
hypothesized to play a central role in its pathophysiology. In pilot studies the
administration of N-Acetylcysteine (NAC) resulted in a reduction of oxidative stress.
Moreover, administration of NAC seemed to decrease hospitalization for painful crises in a
small pilot study in patients with SCD.
This study will be performed as a multicenter, randomized, controlled trial where patients
will be treated with either NAC or placebo for a period of 6 months. The investigators
expect that NAC can reduce the frequency of pain in patients with SCD, thereby improving
their quality of life and participation in society.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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