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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Niacin | 100mg tablets twice daily |
| DIETARY_SUPPLEMENT | Niacinamide | 100mg tablets twice daily |
| OTHER | Placebo | Placebo 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.