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

NCT ID: NCT03808961

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2023-11-01

Brief 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

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1 - Niacin Arm

Oral 100 mg fixed dose twice daily x 18-months (200 mg total / day) with assessments @ baseline, 6 month, 12 month and 18 months

Group Type: ACTIVE_COMPARATOR

Niacin

Intervention Type: DIETARY_SUPPLEMENT

100mg tablets twice daily

Group 2 - Niacinamide Arm

Oral 100 mg fixed dose twice daily (200 mg total / day) x 18-months with assessments @ baseline, 6 month, 12 month and 18 months

Group Type: ACTIVE_COMPARATOR

Niacinamide

Intervention Type: DIETARY_SUPPLEMENT

100mg tablets twice daily

Group 3 - Placebo Wait-listed Arm

Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo tablet twice daily

Interventions

Niacin

100mg tablets twice daily

Intervention Type: DIETARY_SUPPLEMENT

Niacinamide

100mg tablets twice daily

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo tablet twice daily

Intervention Type: OTHER

Other Intervention Names

Vitamin B3, Nicotinic acid; Vitamin B3, Nicotinamide

Eligibility Criteria

Inclusion Criteria

• PD subjects will be adult men and women diagnosed with idiopathic mild to moderately severe PD
• The majority of PD subjects are expected to be > 60 years old
• Disease severity is defined as modified Hoehn & Yahr Stages I-IV (while "On")
• PD is defined according to the UK Brain Bank Criteria made at least six months prior to recruitment to the study
• PD features include the presence of at least two of the four cardinal clinical manifestations of the disease, which are:

• tremor
• rigidity
• bradykinesia
• disturbances of posture or gait, without any other known or suspected cause of Parkinsonism
• Subjects should be stabilized on PD medication for at least 3 months before enrollment into the study
• Subjects' PD drug prescriptions will not be altered nor withheld during the study
• The patient will have signed informed consent

Exclusion Criteria

• Subjects will be excluded if they present with significant cognitive deficits
• A MMSE score of 25 is considered substantial global cognitive impairment
• Subjects will be excluded if they had previous brain surgery or other severe neurological problems

• intracerebral hemorrhage
• traumatic brain injury
• central nervous system malignancy
• active central nervous system (CNS) infection
• significant stroke
• Alzheimer disease or any type of implanted stimulator including but not limited to Deep Brain Stimulator (DBS) or pacemaker
• All subjects must be without evidence of dementia

• defined as a score > 24 the Mini-Mental State Examination and able to understand test instructions
• Subjects must not have functional blindness (inability to participate in gait and visuomotor assessments) or lower limb amputation higher than the forefoot or any orthopedic problem that precludes performance of physical tests
• Subjects must not have known allergy to vitamin B3
• Significant cardiac, pulmonary, hepatic, gastrointestinal, renal disease, or uncontrolled/advanced diabetes are also exclusionary factors, e.g.:

• New York Heart Association Class III or IV congestive heart failure
• endocarditis
• pulmonary insufficiency symptomatic at rest or with mild physical exertion
• acute or chronic hepatitis
• renal failure requiring dialysis
• second and third degree atrioventricular (AV) block
• sick sinus syndrome
• Subjects will be excluded if they are taking B3 but will be included if they are taking B complex that has very low dose B3 (25 mg) which has minimal effects on GPR109A (based on our unpublished observation)
• Overall, the investigators will exercise clinical judgment to exclude a subject from the study if, in the investigators' opinion, that a patient presents with a set of comorbidities which renders unsuitability for the study

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chandramohan Wakade, MBBS

Role: PRINCIPAL_INVESTIGATOR

Charlie Norwood VA Medical Center, Augusta, GA

Locations

Charlie Norwood VA Medical Center, Augusta, GA

Augusta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NURE-013-18S

Identifier Type: -

Identifier Source: org_study_id