An interventional study of niacin and placebo in Parkinson's Disease, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2021-11-17.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
Inflammation plays a central role in Parkinson's disease. The use of anti-inflammatory drugs was found to reduce the risk of PD . Niacin may play an important role in reducing inflammation in PD. The investigators also found that individuals with PD have a chronic niacin deficiency .
The purposes of this study are to (1) examine the blood, urine and spinal fluid of persons with Parkinson's to look for evidence of inflammation and; (2) whether 6 months of vitamin B3 supplements may reduce the inflammation and/or improve symptoms.
Inflammation plays a central role in Parkinson's disease (PD) pathology [1] as evidenced by the presence of microglia in the substantia nigra in post-mortem samples [2] as well as activated microglia and cytokines in clinical and animal studies [3]. The use of non-aspirin non-steroidal anti-inflammatory drugs was found to reduce the risk of PD [4]. The investigators recently identified an anti-inflammatory receptor GPR109A that is upregulated in PD [5]. 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 [5]. Using seed funding from the local PD chapter, the investigators obtained pilot data which suggested that restoring the deficiency via over-the-counter (OTC) supplementation reduced inflammation and decreased the severity of the disease symptoms [6]. In this VA-funded study, the investigators will determine the effect of 6 months' OTC niacin supplementation on inflammation (as assessed in the blood and spinal fluid) and severity of the PD symptoms.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 47 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
PD subjects will be adult men and women diagnosed with idiopathic mild to moderately severe PD defined as modified Hoehn \& Yahr Stages I-III (while "On").
Exclusion Criteria:
Subjects will be excluded if they had previous brain surgery or other severe neurological problems
Significant cardiac, pulmonary, hepatic, gastrointestinal, or renal disease
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Niacin 250 mg is compared to placebo tablet.
Dietary Supplement: niacin
placebo
Other: placebo
Niacin or nicotinic acid 250 mg tablets
Also known as: vitamin B3
placebo tablet
Unified Parkinson's Disease Rating Scale (UPDRS) Change
This is the Unified Parkinson's disease rating scale assessment. The investigators assess I, II, III and V components of the UPDRS. UPDRS 3 is motor skills. Higher scores mean worse outcome. A 0 is minimum and 120 is the maximum.
Time frame: at the recruitment and after 6 months
REM Sleep Pattern
This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the rapid eye movement (REM) sleep as a percentage.
Time frame: baseline and after 6 months
Deep Sleep
This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the deep sleep percentage.
Time frame: At baseline and after 6 months
Light Sleep
This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the light sleep percentage.
Time frame: baseline and 6 months
Sleep Time - Awake
This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the awake time during night sleep percentage.
Time frame: at baseline and 6 months
Mini-Mental State Examination (MMSE) Change
It captures mental status and awareness of time, place and surrounding. A zero is minimum and 30 is maximum. Higher score indicates better cognition.
Time frame: at baseline and after 6 months of treatment
Stroop Test Change
It captures understanding of color and its description within a certain time frame when letters and colors do not match. There are only two choices to pick from and the correct choices should be made to proceed to the next one. Correct choices are given one point and incorrect choices delete one point. Maximum number of correct choices per unit time are recorded. Three initial trials are given to understand the test. No minimum or maximum values. Higher numbers indicate better cognition.
Time frame: at the baseline and after 6 months of intervention
Fatigue Severity Scale
Fatigue was rated from 0-7 in a fatigue questionnaire. A 0 being the least and 7 being the highest level of fatigue.
Time frame: at baseline and after 6 months
Cerebrospinal Fluid Changes - Interleukin 6 (IL6)
IL-6 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.
Time frame: at baseline and after 6 months
Cerebrospinal Fluid Changes - Interleukin 10 (IL-10)
IL-10 will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.
Time frame: at baseline and after 6 months
Niacin Metabolite in Urine - Niacin
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels
Time frame: at baseline and after 6 months
Niacin Metabolites in Urine - NAM Nicotinamide
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels
Time frame: at baseline and 6 months
Niacin Changes in Plasma - Niacin
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels.
Time frame: baseline and 6 months
Niacin Changes in Plasma - NUA Nicotinuric Acid
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels
Time frame: at baseline and 6 months
Cerebrospinal Fluid Changes - Interleukin 8 (IL8)
IL-8 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.
Time frame: at baseline and after 6 months
Niacin Metabolite in Urine - Nicotinuric Acid NUA
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels
Time frame: at baseline and after 6 months
CSF Fluid Changes - Interleukin 1B (IL-1B)
IL-1beta levels were tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.
Time frame: at baseline and 6 months
Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta)
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MIP-1 beta here.
Time frame: at baseline and after 6 months
Macrophage Changes
The blood is tested to report G-protein coupled receptor 109A (GPR109A) levels in macrophages in M1 and M2 populations.
Time frame: at baseline and after 6 months
Niacin Metabolite Changes in Plasma - Nicotinamide (NAM)
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels.
Time frame: at baseline and after 6 months
CSF Changes in Interferon Gamma (IF-gamma)
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of IF-gamma beta here.
Time frame: at baseline and after 6 months
CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha)
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of TNF-alpha here.
Time frame: at baseline and after 6 months
Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10)
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of IP-10 here.
Time frame: at baseline and after 6 months
Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4)
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MCP4 here.
Time frame: at baseline and after 6 months
Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MIP1-alpha here.
Time frame: at baseline and after 6 months
Plasma Cytokines - IF Gamma
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IF-gamma here.
Time frame: at baseline and after 6 months
Plasma Cytokines - IL-10
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-10 here.
Time frame: at baseline and after 6 months
Plasma Cytokines - IL1-B
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-1B here.
Time frame: at baseline and after 6 months
Plasma Cytokines - IL-6
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-6 here.
Time frame: at baseline and after 6 months
Plasma Cytokines - IL-8
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-8 here.
Time frame: at baseline and after 6 Months
Plasma Cytokines - TNF-alpha
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of TNF-alpha here.
Time frame: at baseline and after 6 months
Plasma Cytokines - IP-10
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IP-10 here.
Time frame: at baseline and after 6 months
Plasma Cytokines - MCP-4
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MCP-4 here.
Time frame: at baseline and after 6 months
Plasma Cytokines - MIP1-alpha
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MIP1-alpha here.
Time frame: at baseline and after 6 months
Plasma Cytokines - MIP1-beta
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MIP1-beta here.
Time frame: at baseline and after 6 months
Plasma Levels - Serotonin
Plasma serotonin levels
Time frame: at baseline and after 6 months
| Milestone | Niacin | Placebo |
|---|---|---|
| Started | 21 | 26 |
| Completed | 18 | 21 |
| Not completed | 3 | 5 |
| Withdrew: Withdrawal by subject | 3 | 5 |
This is the Unified Parkinson's disease rating scale assessment. The investigators assess I, II, III and V components of the UPDRS. UPDRS 3 is motor skills. Higher scores mean worse outcome. A 0 is minimum and 120 is the maximum.
| units on a scale | Niacin | Placebo |
|---|---|---|
| baseline | 21.25 ± 15.8 | 22.4 ± 11.8 |
| 6 months | 20.8 ± 12.4 | 22.31 ± 16.5 |
This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the rapid eye movement (REM) sleep as a percentage.
| percentage of sleep time | Niacin | Placebo |
|---|---|---|
| baseline | 20.09 ± 13.36 | 15.83 ± 12.1 |
| 6 months | 21.1 ± 11.6 | 21.45 ± 16.3 |
This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the deep sleep percentage.
| percentage of deep sleep time | Niacin | Placebo |
|---|---|---|
| at baseline | 8.17 ± 5.11 | 8.48 ± 6.07 |
| 6 months | 12.28 ± 16.27 | 8.32 ± 6.09 |
This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the light sleep percentage.
| percentage of light sleep time | Niacin | Placebo |
|---|---|---|
| baseline | 49.2 ± 17.9 | 53.5 ± 18.2 |
| 6 months | 50.9 ± 15.6 | 47.5 ± 18.5 |
This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the awake time during night sleep percentage.
| percentage of awake-sleep time | Niacin | Placebo |
|---|---|---|
| baseline | 20.2 ± 23.23 | 21.95 ± 17.4 |
| 6 month | 13.5 ± 10.3 | 23 ± 20.7 |
It captures mental status and awareness of time, place and surrounding. A zero is minimum and 30 is maximum. Higher score indicates better cognition.
| score on a scale | Niacin | Placebo |
|---|---|---|
| baseline | 29.94 ± 0.24 | 29.81 ± 0.88 |
| 6 months | 29.94 ± 0.24 | 29.71 ± 0.78 |
It captures understanding of color and its description within a certain time frame when letters and colors do not match. There are only two choices to pick from and the correct choices should be made to proceed to the next one. Correct choices are given one point and incorrect choices delete one point. Maximum number of correct choices per unit time are recorded. Three initial trials are given to understand the test. No minimum or maximum values. Higher numbers indicate better cognition.
| number of correct responses/unit time | Niacin | Placebo |
|---|---|---|
| baseline | 6.18 ± 7.92 | 8.13 ± 6.64 |
| 6 months | 8.37 ± 5.6 | 8.72 ± 6.86 |
Fatigue was rated from 0-7 in a fatigue questionnaire. A 0 being the least and 7 being the highest level of fatigue.
| score on a scale | Niacin | Placebo |
|---|---|---|
| baseline | 40.3 ± 11.99 | 36.7 ± 13 |
| 6 months | 38.5 ± 10.99 | 36.7 ± 14.2 |
IL-6 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 1.6 ± 0.5 | 1.9 ± 2 |
| 6 months | 1.2 ± 0.37 | 1.2 ± 0.4 |
IL-10 will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 0.42 ± 0.64 | 0.13 ± 0.16 |
| 6 months | 0.09 ± 0.01 | 0.08 ± 0.04 |
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels
| ng/L | Niacin | Placebo |
|---|---|---|
| baseline | 1826.8 ± 663.2 | 1533 ± 895.9 |
| 6 months | 1913.8 ± 481 | 1660.6 ± 431.7 |
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels
| ng/L | Niacin | Placebo |
|---|---|---|
| baseline | 815.5 ± 1155 | 205.8 ± 312.99 |
| 6 months | 1140.3 ± 1058.4 | 685.4 ± 709.3 |
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels.
| nM/L | Niacin | Placebo |
|---|---|---|
| baseline | 68.5 ± 95.96 | 55.8 ± 88.3 |
| 6 months | 80.83 ± 92.4 | 92.2 ± 59.1 |
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels
| nM/L | Niacin | Placebo |
|---|---|---|
| at baseline | 0 ± 0 | 4.99 ± 17.98 |
| 6 months | 313.9 ± 442.7 | 0.38 ± 1.53 |
IL-8 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 62.9 ± 5.27 | 102.5 ± 74.2 |
| 6 months | 91.6 ± 51.2 | 77.9 ± 19 |
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels
| ng/L | Niacin | Placebo |
|---|---|---|
| at baseline | 3565.3 ± 7364.8 | 1021.8 ± 4538.7 |
| 6 months | 20132.9 ± 26789.4 | 2803.7 ± 8459.9 |
IL-1beta levels were tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.
| pg/ml | Niacin | Placebo |
|---|---|---|
| Baseline | 0.56 ± 0.8 | 0.28 ± 0.14 |
| 6 months | 0.21 ± 0.06 | 0.22 ± 0.07 |
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MIP-1 beta here.
| pico grams per ml | Niacin | Placebo |
|---|---|---|
| baseline | 14.7 ± 5.02 | 9.3 ± 2.2 |
| 6 months | 15.9 ± 1.3 | 7.7 ± 4.2 |
The blood is tested to report G-protein coupled receptor 109A (GPR109A) levels in macrophages in M1 and M2 populations.
| percentage of macrophages | Niacin | Placebo |
|---|---|---|
| baseline | 54.08 ± 4.08 | 56 ± 4.5 |
| 6 months | 48.92 ± 3.9 | 54.5 ± 5.2 |
Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels.
| uM/L | Niacin | Placebo |
|---|---|---|
| baseline | 0.43 ± 0.30 | 0.34 ± 0.19 |
| 6 months | 1.07 ± 0.46 | 0.38 ± 0.15 |
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of IF-gamma beta here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 0.21 ± 0.3 | 0.39 ± 0.39 |
| 6 months | 2.2 ± 2.3 | 0.89 ± 0.52 |
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of TNF-alpha here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 0.53 ± 0.87 | 0.18 ± 0.62 |
| 6 months | 0.23 ± 0.05 | 0.2 ± 0.31 |
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of IP-10 here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 359.8 ± 193.5 | 512 ± 304.8 |
| 6 months | 936.2 ± 1018 | 514.5 ± 351.1 |
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MCP4 here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 24.6 ± 2.03 | 7.3 ± 8.1 |
| 6 months | 3.9 ± 5.6 | 6.7 ± 5.09 |
Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MIP1-alpha here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 17.8 ± 6 | 18.7 ± 3.8 |
| 6 months | 20.5 ± 18.2 | 17.3 ± 9.8 |
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IF-gamma here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 16.2 ± 15.6 | 21 ± 33.1 |
| 6 months | 84.8 ± 287.7 | 15.95 ± 19.3 |
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-10 here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 0.41 ± 0.28 | 0.41 ± 0.34 |
| 6 months | 0.5 ± 0.64 | 0.41 ± 0.28 |
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-1B here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 0.32 ± 0.34 | 0.37 ± 0.41 |
| 6 months | 0.23 ± 0.17 | 0.29 ± 0.28 |
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-6 here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 5.7 ± 17.8 | 8.7 ± 34.2 |
| 6 months | 2.97 ± 4.25 | 11.04 ± 40.7 |
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-8 here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 6.7 ± 2.2 | 6.2 ± 2.1 |
| 6 months | 8.1 ± 3.5 | 6.6 ± 2.8 |
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of TNF-alpha here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 2.05 ± 4.7 | 0.96 ± 0.29 |
| 6 months | 2.26 ± 5.2 | 1.0 ± 0.31 |
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IP-10 here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 443.3 ± 197.3 | 402.7 ± 252.5 |
| 6 months | 542.1 ± 295.8 | 355.4 ± 158.6 |
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MCP-4 here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 112.3 ± 73.8 | 104.6 ± 35.7 |
| 6 months | 106.4 ± 44 | 90.7 ± 41.3 |
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MIP1-alpha here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 23.3 ± 20.5 | 42.1 ± 116.7 |
| 6 months | 23.2 ± 9.3 | 38.9 ± 75.5 |
Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MIP1-beta here.
| pg/ml | Niacin | Placebo |
|---|---|---|
| baseline | 69.3 ± 26.1 | 65.8 ± 29.8 |
| 6 months | 65.5 ± 34.5 | 56 ± 24 |
Plasma serotonin levels
| mg/dL | Niacin | Placebo |
|---|---|---|
| baseline | 84.2 ± 68.2 | 89.6 ± 60.5 |
| 6 months | 83 ± 75.2 | 64.2 ± 44.5 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Niacin | 0/21 (0%) | 0/21 (0%) | 7/21 (33.3%) |
| Placebo | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Event | Niacin | Placebo |
|---|---|---|
| flushingBlood and lymphatic system disorders | 7/21 | 0/26 |
| Age, Continuous(years) | Niacin | Placebo | Total |
|---|---|---|---|
| Mean | 68.2 ± 6 | 68 ± 10.7 | 68.1 ± 8.7 |
| Sex: Female, Male(Participants) | Niacin | Placebo | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 19 | 24 | 43 |
| Ethnicity (NIH/OMB)(Participants) | Niacin | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 21 | 26 | 47 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Niacin | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 3 |
| White | 21 | 23 | 44 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Niacin | Placebo | Total |
|---|---|---|---|
| United States | 21 | 26 | 47 |
| UPDRS III(units on a scale) | Niacin | Placebo | Total |
|---|---|---|---|
| Mean | 21.25 ± 15.8 | 22.4 ± 11.8 | 21.9 ± 15.3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — As the investigators request, we will share the data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: One year after the study is closed.
Access criteria: When we are ready to publish, the data will be available.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Niacin
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