Clinical Trials Directory

Trials / Terminated

TerminatedNCT03808961

Low Dose Niacin (Vitamin B3) for Parkinson's Disease

NAPS: Niacin for Parkinson's Disease

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
7 (actual)
Sponsor
VA Office of Research and Development · Federal
Sex
All
Age
35 Years
Healthy volunteers
Not accepted

Summary

(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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTNiacin100mg tablets twice daily
DIETARY_SUPPLEMENTNiacinamide100mg tablets twice daily
OTHERPlaceboPlacebo tablet twice daily

Timeline

Start date
2020-01-01
Primary completion
2023-11-01
Completion
2023-11-01
First posted
2019-01-18
Last updated
2025-03-04
Results posted
2025-03-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03808961. Inclusion in this directory is not an endorsement.