GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
NCT03462680, Not applicable, Completed, VA Office of Research and Development; results first posted 2021-11-17
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures | ClinicalTrials.gov |
| NCT number | NCT03462680 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 47 participants, actual | ClinicalTrials.gov |
| Lead sponsor | VA Office of Research and Development | ClinicalTrials.gov |
| Conditions | Parkinson's Disease | ClinicalTrials.gov |
| Interventions | niacin, placebo | ClinicalTrials.gov |
| First posted | 2018-03-12 | ClinicalTrials.gov |
| Last updated | 2021-11-17 | ClinicalTrials.gov |
| Results first posted | 2021-11-17 | ClinicalTrials.gov |
| Limitations and caveats | Additional studies are required including a larger cohort and multi-center to further generalize findings, as well as comparing niacin to placebo for longer than 6 months before optimal information can be obtained for use in clinical settings. | ClinicalTrials.gov |
Registered outcomes 36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Unified Parkinson's Disease Rating Scale (UPDRS) Change | at the recruitment and after 6 months | 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. | ClinicalTrials.gov |
| Primary | REM Sleep Pattern | baseline and after 6 months | 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. | ClinicalTrials.gov |
| Primary | Deep Sleep | At baseline and after 6 months | 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. | ClinicalTrials.gov |
| Primary | Light Sleep | baseline and 6 months | 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. | ClinicalTrials.gov |
| Primary | Sleep Time - Awake | at baseline and 6 months | 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. | ClinicalTrials.gov |
| Primary | Mini-Mental State Examination (MMSE) Change | at baseline and after 6 months of treatment | It captures mental status and awareness of time, place and surrounding. A zero is minimum and 30 is maximum. Higher score indicates better cognition. | ClinicalTrials.gov |
| Primary | Stroop Test Change | at the baseline and after 6 months of intervention | 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. | ClinicalTrials.gov |
| Primary | Fatigue Severity Scale | at baseline and after 6 months | Fatigue was rated from 0-7 in a fatigue questionnaire. A 0 being the least and 7 being the highest level of fatigue. | ClinicalTrials.gov |
| Secondary | Cerebrospinal Fluid Changes - Interleukin 6 (IL6) | at baseline and after 6 months | IL-6 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. | ClinicalTrials.gov |
| Secondary | Cerebrospinal Fluid Changes - Interleukin 10 (IL-10) | at baseline and after 6 months | IL-10 will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. | ClinicalTrials.gov |
| Secondary | Niacin Metabolite in Urine - Niacin | at baseline and after 6 months | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | ClinicalTrials.gov |
| Secondary | Niacin Metabolites in Urine - NAM Nicotinamide | at baseline and 6 months | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | ClinicalTrials.gov |
| Secondary | Niacin Changes in Plasma - Niacin | baseline and 6 months | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. | ClinicalTrials.gov |
| Secondary | Niacin Changes in Plasma - NUA Nicotinuric Acid | at baseline and 6 months | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | ClinicalTrials.gov |
| Secondary | Cerebrospinal Fluid Changes - Interleukin 8 (IL8) | at baseline and after 6 months | IL-8 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. | ClinicalTrials.gov |
| Secondary | Niacin Metabolite in Urine - Nicotinuric Acid NUA | at baseline and after 6 months | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels | ClinicalTrials.gov |
| Secondary | CSF Fluid Changes - Interleukin 1B (IL-1B) | at baseline and 6 months | IL-1beta levels were tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. | ClinicalTrials.gov |
| Secondary | Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta) | at baseline and after 6 months | 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. | ClinicalTrials.gov |
| Secondary | Macrophage Changes | at baseline and after 6 months | The blood is tested to report G-protein coupled receptor 109A (GPR109A) levels in macrophages in M1 and M2 populations. | ClinicalTrials.gov |
| Secondary | Niacin Metabolite Changes in Plasma - Nicotinamide (NAM) | at baseline and after 6 months | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. | ClinicalTrials.gov |
Outcomes 36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Unified Parkinson's Disease Rating Scale (UPDRS) Change | at the recruitment and after 6 months | Patients who completed 6 months were analyzed for this measure (39 subjects). | units on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | REM Sleep Pattern | baseline and after 6 months | Patients who completed 6 months were analyzed for this measure (39 subjects). | percentage of sleep time | MEAN | ClinicalTrials.gov |
| PRIMARY | Deep Sleep | At baseline and after 6 months | Patients who completed 6 months were analyzed for this measure (39 subjects). | percentage of deep sleep time | MEAN | ClinicalTrials.gov |
| PRIMARY | Light Sleep | baseline and 6 months | Patients who completed 6 months were analyzed for this measure (39 subjects). | percentage of light sleep time | MEAN | ClinicalTrials.gov |
| PRIMARY | Sleep Time - Awake | at baseline and 6 months | Patients who completed 6 months were analyzed for this measure (39 subjects). | percentage of awake-sleep time | MEAN | ClinicalTrials.gov |
| PRIMARY | Mini-Mental State Examination (MMSE) Change | at baseline and after 6 months of treatment | Patients who completed 6 months were analyzed for this measure (39 subjects). | score on a scale | MEAN | ClinicalTrials.gov |
| PRIMARY | Stroop Test Change | at the baseline and after 6 months of intervention | Stroop test was added after recruitment of few subjects. | number of correct responses/unit time | MEAN | ClinicalTrials.gov |
| PRIMARY | Fatigue Severity Scale | at baseline and after 6 months | Patients who completed 6 months were analyzed for this measure (39 subjects). | score on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Cerebrospinal Fluid Changes - Interleukin 6 (IL6) | at baseline and after 6 months | Not all subjects donated CSF. All CSF samples are recorded here. | pg/ml | MEAN | ClinicalTrials.gov |
| SECONDARY | Cerebrospinal Fluid Changes - Interleukin 10 (IL-10) | at baseline and after 6 months | Not all subjects donated CSF. All CSF samples are recorded here. | pg/ml | MEAN | ClinicalTrials.gov |
| SECONDARY | Niacin Metabolite in Urine - Niacin | at baseline and after 6 months | A subset of groups were analyzed. | ng/L | MEAN | ClinicalTrials.gov |
| SECONDARY | Niacin Metabolites in Urine - NAM Nicotinamide | at baseline and 6 months | A subset of subjects were randomly selected for this analysis. | ng/L | MEAN | ClinicalTrials.gov |
| SECONDARY | Niacin Changes in Plasma - Niacin | baseline and 6 months | A subset of subjects were randomly selected for this analysis. | nM/L | MEAN | ClinicalTrials.gov |
| SECONDARY | Niacin Changes in Plasma - NUA Nicotinuric Acid | at baseline and 6 months | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. Undetectable values are reported as zero. A subset of the groups were analyzed. | nM/L | MEAN | ClinicalTrials.gov |
| SECONDARY | Cerebrospinal Fluid Changes - Interleukin 8 (IL8) | at baseline and after 6 months | Not all subjects donated CSF. All CSF samples are recorded here. | pg/ml | MEAN | ClinicalTrials.gov |
| SECONDARY | Niacin Metabolite in Urine - Nicotinuric Acid NUA | at baseline and after 6 months | Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. A subset of the groups were analyzed. | ng/L | MEAN | ClinicalTrials.gov |
| SECONDARY | CSF Fluid Changes - Interleukin 1B (IL-1B) | at baseline and 6 months | Not all subjects donated CSF. All CSF samples are recorded here. | pg/ml | MEAN | ClinicalTrials.gov |
| SECONDARY | Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta) | at baseline and after 6 months | Not all subjects donated CSF. All CSF samples are recorded here. | pico grams per ml | MEAN | ClinicalTrials.gov |
| SECONDARY | Macrophage Changes | at baseline and after 6 months | A subset of subjects were randomly selected for this measure and all the data is recorded here that was captured. | percentage of macrophages | MEAN | ClinicalTrials.gov |
| SECONDARY | Niacin Metabolite Changes in Plasma - Nicotinamide (NAM) | at baseline and after 6 months | A subset of subjects were randomly selected for this analysis. | uM/L | MEAN | ClinicalTrials.gov |
Results by group 144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) Change | Niacin | baseline | 21.25 | Standard Deviation 15.8 | units on a scale | ClinicalTrials.gov |
| Unified Parkinson's Disease Rating Scale (UPDRS) Change | Placebo | baseline | 22.4 | Standard Deviation 11.8 | units on a scale | ClinicalTrials.gov |
| Unified Parkinson's Disease Rating Scale (UPDRS) Change | Niacin | 6 months | 20.8 | Standard Deviation 12.4 | units on a scale | ClinicalTrials.gov |
| Unified Parkinson's Disease Rating Scale (UPDRS) Change | Placebo | 6 months | 22.31 | Standard Deviation 16.5 | units on a scale | ClinicalTrials.gov |
| REM Sleep Pattern | Niacin | baseline | 20.09 | Standard Deviation 13.36 | percentage of sleep time | ClinicalTrials.gov |
| REM Sleep Pattern | Placebo | baseline | 15.83 | Standard Deviation 12.1 | percentage of sleep time | ClinicalTrials.gov |
| REM Sleep Pattern | Niacin | 6 months | 21.1 | Standard Deviation 11.6 | percentage of sleep time | ClinicalTrials.gov |
| REM Sleep Pattern | Placebo | 6 months | 21.45 | Standard Deviation 16.3 | percentage of sleep time | ClinicalTrials.gov |
| Deep Sleep | Niacin | at baseline | 8.17 | Standard Deviation 5.11 | percentage of deep sleep time | ClinicalTrials.gov |
| Deep Sleep | Placebo | at baseline | 8.48 | Standard Deviation 6.07 | percentage of deep sleep time | ClinicalTrials.gov |
| Deep Sleep | Niacin | 6 months | 12.28 | Standard Deviation 16.27 | percentage of deep sleep time | ClinicalTrials.gov |
| Deep Sleep | Placebo | 6 months | 8.32 | Standard Deviation 6.09 | percentage of deep sleep time | ClinicalTrials.gov |
| Light Sleep | Niacin | baseline | 49.2 | Standard Deviation 17.9 | percentage of light sleep time | ClinicalTrials.gov |
| Light Sleep | Placebo | baseline | 53.5 | Standard Deviation 18.2 | percentage of light sleep time | ClinicalTrials.gov |
| Light Sleep | Niacin | 6 months | 50.9 | Standard Deviation 15.6 | percentage of light sleep time | ClinicalTrials.gov |
| Light Sleep | Placebo | 6 months | 47.5 | Standard Deviation 18.5 | percentage of light sleep time | ClinicalTrials.gov |
| Sleep Time - Awake | Niacin | baseline | 20.2 | Standard Deviation 23.23 | percentage of awake-sleep time | ClinicalTrials.gov |
| Sleep Time - Awake | Placebo | baseline | 21.95 | Standard Deviation 17.4 | percentage of awake-sleep time | ClinicalTrials.gov |
| Sleep Time - Awake | Niacin | 6 month | 13.5 | Standard Deviation 10.3 | percentage of awake-sleep time | ClinicalTrials.gov |
| Sleep Time - Awake | Placebo | 6 month | 23 | Standard Deviation 20.7 | percentage of awake-sleep time | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Niacin | 21 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo | 26 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Niacin | 18 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo | 21 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Niacin | 3 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo | 5 | ClinicalTrials.gov |
Adverse events 2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | flushing | Blood and lymphatic system disorders | Niacin | 7 | 21 | 7 | ClinicalTrials.gov |
| other | flushing | Blood and lymphatic system disorders | Placebo | 0 | 26 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Niacin | 0 | 21 | ClinicalTrials.gov |
| Total, all-cause mortality | Placebo | 0 | 26 | ClinicalTrials.gov |
| Total, other adverse events | Niacin | 7 | 21 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 0 | 26 | ClinicalTrials.gov |
| Total, serious adverse events | Niacin | 0 | 21 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 0 | 26 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Niacin vs Placebo: deaths from any cause | Trial comparisons |
| Niacin vs Placebo: serious adverse events | Trial comparisons |
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)