Condition or disease | Intervention/treatment | Phase |
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Parkinson's Disease | Dietary Supplement: Niacin Dietary Supplement: Niacinamide Other: Placebo | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | There are three arms, niacin, niacinamide and placebo. They are double blind and randomized. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Only Pharmacists keep the log of the drug dispensed. Everyone else is blinded. |
Primary Purpose: | Health Services Research |
Official Title: | NAPS: Niacin for Parkinsons Disease |
Actual Study Start Date : | January 1, 2020 |
Estimated Primary Completion Date : | November 1, 2023 |
Estimated Study Completion Date : | April 1, 2024 |
Arm | Intervention/treatment |
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Active Comparator: 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
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Dietary Supplement: Niacin
100mg tablets twice daily
Other Name: Vitamin B3, Nicotinic acid
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Active Comparator: 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
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Dietary Supplement: Niacinamide
100mg tablets twice daily
Other Name: Vitamin B3, Nicotinamide
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Placebo Comparator: Group 3 ? Placebo Wait-listed Arm
Oral placebo twice daily x 18- months with assessments @ baseline, 6 month, 12 month and 18 months
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Other: Placebo
Placebo tablet
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Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
PD features include the presence of at least two of the four cardinal clinical manifestations of the disease, which are:
Exclusion Criteria:
Subjects will be excluded if they had previous brain surgery or other severe neurological problems
All subjects must be without evidence of dementia
Significant cardiac, pulmonary, hepatic, gastrointestinal, renal disease, or uncontrolled/advanced diabetes are also exclusionary factors, e.g.:
Contact: Chandramohan Wakade, MBBS | (706) 733-0188 ext 2378 | Chandramohan.Wakade@va.gov | |
Contact: John C Morgan, MD | (706) 733-0188 | john.morgan@va.gov |
United States, Georgia | |
Charlie Norwood VA Medical Center, Augusta, GA | Recruiting |
Augusta, Georgia, United States, 30904 | |
Contact: Thomas J Hartney, MD 706-733-0188 ext 2510 Tom.Hartney@va.gov | |
Contact: Christopher Rogers (706) 733-188 ext 2508 Christopher.Rogers7@va.gov | |
Principal Investigator: Chandramohan Wakade, MBBS |
Principal Investigator: | Chandramohan Wakade, MBBS | Charlie Norwood VA Medical Center, Augusta, GA |
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | January 16, 2019 | ||||||||||||||||||
First Posted Date ICMJE | January 18, 2019 | ||||||||||||||||||
Last Update Posted Date | April 19, 2021 | ||||||||||||||||||
Actual Study Start Date ICMJE | January 1, 2020 | ||||||||||||||||||
Estimated Primary Completion Date | November 1, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Niacin for Parkinsons Disease | ||||||||||||||||||
Official Title ICMJE | NAPS: Niacin for Parkinsons Disease | ||||||||||||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: There are three arms, niacin, niacinamide and placebo. They are double blind and randomized. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Only Pharmacists keep the log of the drug dispensed. Everyone else is blinded. Primary Purpose: Health Services Research
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Condition ICMJE | Parkinson's Disease | ||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||||
Estimated Enrollment ICMJE |
100 | ||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
Estimated Study Completion Date ICMJE | April 1, 2024 | ||||||||||||||||||
Estimated Primary Completion Date | November 1, 2023 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 35 Years and older (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT03808961 | ||||||||||||||||||
Other Study ID Numbers ICMJE | NURE-013-18S | ||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | VA Office of Research and Development | ||||||||||||||||||
Study Sponsor ICMJE | VA Office of Research and Development | ||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | VA Office of Research and Development | ||||||||||||||||||
Verification Date | April 2021 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |