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NAPS: Niacin for Parkinson's Disease
(1) To examine the blood, urine and spinal fluid of persons with Parkinson's to look for evidence of inflammation and; (2) whether 18 months of vitamin B3(niacin or niacinamide) supplementation may reduce the inflammation and/or improve PD motor and non-motor symptoms.
Number of people affected by Parkinson's disease is increasing each year. Vitamin B3 (Niacin/Niacinamide) supplement can be used to slow the progression of PD. Inflammation plays a central role in Parkinson's disease (PD) pathology as evidenced by the presence of microglia in the substantia nigra in post-mortem samples as well as activated microglia and cytokines in clinical and animal studies. The use of non-aspirin non-steroidal anti-inflammatory drugs was found to reduce the risk of PD. The investigators recently identified an anti-inflammatory receptor GPR109A that is upregulated in PD. Niacin has a high affinity for this receptor, suggesting that it (niacin) may play an important role in reducing inflammation in PD. The investigators also found that individuals with PD have a chronic niacin deficiency. In a three month trial at Augusta University (the investigators' affiliate) the investigators demonstrated that niacin was helpful for PD patients in reducing inflammatory macrophages and boosting the anti-inflammatory macrophages in blood. In this VA-funded study, the investigators will determine the effect of 18 months over-the-counter (OTC) niacin or niacinamide supplementation on inflammation (as assessed in the blood and spinal fluid) and severity of the PD symptoms.
Age
35 - No limit years
Sex
ALL
Healthy Volunteers
No
Charlie Norwood VA Medical Center, Augusta, GA
Augusta, Georgia, United States
Start Date
January 1, 2020
Primary Completion Date
November 1, 2023
Completion Date
November 1, 2023
Last Updated
March 4, 2025
7
ACTUAL participants
Niacin
DIETARY_SUPPLEMENT
Niacinamide
DIETARY_SUPPLEMENT
Placebo
OTHER
Lead Sponsor
VA Office of Research and Development
NCT07310264
NCT02119611
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07216976