Parkinson's Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTniacin
Niacin or nicotinic acid 250 mg tablets
OTHERplacebo
placebo tablet
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Only Pharmacists keep the log of the drug dispensed. Everyone else is blinded.
Intervention model description
There are two arms, niacin and placebo. They are double blind and randomized.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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). * PD is defined according to the United Kingdom 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, and 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, i.e., they will be tested while On. * The patient will have signed informed consent. * Subjects who do not have PD (i.e., healthy or have other medical conditions such as traumatic brain injury (TBI), stroke, or other syndromes in which inflammation plays a role in the condition) will also be recruited as control subjects. * This will allow us to estimate whether these other conditions show similar or unique inflammatory profile.
Exclusion criteria
* 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 * Allergic to niacin * Significant cardiac, pulmonary, hepatic, gastrointestinal, or renal disease * 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 block or sick sinus syndrome), or diabetes are also exclusionary factors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| CSF Changes in Interferon Gamma (IF-gamma) | 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 IF-gamma beta here. |
| CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha) | 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 TNF-alpha here. |
| Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10) | 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 IP-10 here. |
| Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4) | 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 MCP4 here. |
| Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha | 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 MIP1-alpha here. |
| Plasma Cytokines - IF Gamma | at baseline and after 6 months | 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. |
| 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. |
| Plasma Cytokines - IL1-B | at baseline and after 6 months | 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. |
| Plasma Cytokines - IL-6 | at baseline and after 6 months | 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. |
| Plasma Cytokines - IL-8 | at baseline and after 6 Months | 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. |
| Plasma Cytokines - TNF-alpha | at baseline and after 6 months | 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. |
| Plasma Cytokines - IP-10 | at baseline and after 6 months | 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. |
| Plasma Cytokines - MCP-4 | at baseline and after 6 months | 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. |
| Plasma Cytokines - MIP1-alpha | at baseline and after 6 months | 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. |
| Plasma Cytokines - MIP1-beta | at baseline and after 6 months | 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. |
| Plasma Levels - Serotonin | at baseline and after 6 months | Plasma serotonin levels |
| Plasma Cytokines - IL-10 | at baseline and after 6 months | 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. |
| 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. |
| 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 |
| 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 |
| 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. |
| 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 |
| 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. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Niacin Niacin 250 mg is compared to placebo tablet.
niacin: Niacin or nicotinic acid 250 mg tablets | 21 |
| Placebo placebo
placebo: placebo tablet | 26 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Niacin | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 6 | 68.1 years STANDARD_DEVIATION 8.7 | 68 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 47 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 44 Participants | 23 Participants |
| Region of Enrollment United States | 21 Participants | 47 Participants | 26 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 19 Participants | 43 Participants | 24 Participants |
| UPDRS III | 21.25 units on a scale STANDARD_DEVIATION 15.8 | 21.9 units on a scale STANDARD_DEVIATION 15.3 | 22.4 units on a scale STANDARD_DEVIATION 11.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 26 |
| other Total, other adverse events | 7 / 21 | 0 / 26 |
| serious Total, serious adverse events | 0 / 21 | 0 / 26 |
Outcome results
Primary
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
Population: Patients who completed 6 months were analyzed for this measure (39 subjects).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Deep Sleep | at baseline | 8.17 percentage of deep sleep time | Standard Deviation 5.11 |
| Niacin | Deep Sleep | 6 months | 12.28 percentage of deep sleep time | Standard Deviation 16.27 |
| Placebo | Deep Sleep | at baseline | 8.48 percentage of deep sleep time | Standard Deviation 6.07 |
| Placebo | Deep Sleep | 6 months | 8.32 percentage of deep sleep time | Standard Deviation 6.09 |
Primary
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
Population: Patients who completed 6 months were analyzed for this measure (39 subjects).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Fatigue Severity Scale | baseline | 40.3 score on a scale | Standard Deviation 11.99 |
| Niacin | Fatigue Severity Scale | 6 months | 38.5 score on a scale | Standard Deviation 10.99 |
| Placebo | Fatigue Severity Scale | baseline | 36.7 score on a scale | Standard Deviation 13 |
| Placebo | Fatigue Severity Scale | 6 months | 36.7 score on a scale | Standard Deviation 14.2 |
Primary
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
Population: Patients who completed 6 months were analyzed for this measure (39 subjects).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Light Sleep | 6 months | 50.9 percentage of light sleep time | Standard Deviation 15.6 |
| Niacin | Light Sleep | baseline | 49.2 percentage of light sleep time | Standard Deviation 17.9 |
| Placebo | Light Sleep | baseline | 53.5 percentage of light sleep time | Standard Deviation 18.2 |
| Placebo | Light Sleep | 6 months | 47.5 percentage of light sleep time | Standard Deviation 18.5 |
Primary
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
Population: Patients who completed 6 months were analyzed for this measure (39 subjects).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Mini-Mental State Examination (MMSE) Change | baseline | 29.94 score on a scale | Standard Deviation 0.24 |
| Niacin | Mini-Mental State Examination (MMSE) Change | 6 months | 29.94 score on a scale | Standard Deviation 0.24 |
| Placebo | Mini-Mental State Examination (MMSE) Change | baseline | 29.81 score on a scale | Standard Deviation 0.88 |
| Placebo | Mini-Mental State Examination (MMSE) Change | 6 months | 29.71 score on a scale | Standard Deviation 0.78 |
Primary
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
Population: Patients who completed 6 months were analyzed for this measure (39 subjects).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | REM Sleep Pattern | baseline | 20.09 percentage of sleep time | Standard Deviation 13.36 |
| Niacin | REM Sleep Pattern | 6 months | 21.1 percentage of sleep time | Standard Deviation 11.6 |
| Placebo | REM Sleep Pattern | baseline | 15.83 percentage of sleep time | Standard Deviation 12.1 |
| Placebo | REM Sleep Pattern | 6 months | 21.45 percentage of sleep time | Standard Deviation 16.3 |
Primary
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
Population: Patients who completed 6 months were analyzed for this measure (39 subjects).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Sleep Time - Awake | baseline | 20.2 percentage of awake-sleep time | Standard Deviation 23.23 |
| Niacin | Sleep Time - Awake | 6 month | 13.5 percentage of awake-sleep time | Standard Deviation 10.3 |
| Placebo | Sleep Time - Awake | baseline | 21.95 percentage of awake-sleep time | Standard Deviation 17.4 |
| Placebo | Sleep Time - Awake | 6 month | 23 percentage of awake-sleep time | Standard Deviation 20.7 |
Primary
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
Population: Stroop test was added after recruitment of few subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Stroop Test Change | baseline | 6.18 number of correct responses/unit time | Standard Deviation 7.92 |
| Niacin | Stroop Test Change | 6 months | 8.37 number of correct responses/unit time | Standard Deviation 5.6 |
| Placebo | Stroop Test Change | baseline | 8.13 number of correct responses/unit time | Standard Deviation 6.64 |
| Placebo | Stroop Test Change | 6 months | 8.72 number of correct responses/unit time | Standard Deviation 6.86 |
Primary
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
Population: Patients who completed 6 months were analyzed for this measure (39 subjects).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Unified Parkinson's Disease Rating Scale (UPDRS) Change | baseline | 21.25 units on a scale | Standard Deviation 15.8 |
| Niacin | Unified Parkinson's Disease Rating Scale (UPDRS) Change | 6 months | 20.8 units on a scale | Standard Deviation 12.4 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Change | baseline | 22.4 units on a scale | Standard Deviation 11.8 |
| Placebo | Unified Parkinson's Disease Rating Scale (UPDRS) Change | 6 months | 22.31 units on a scale | Standard Deviation 16.5 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10) | baseline | 359.8 pg/ml | Standard Deviation 193.5 |
| Niacin | Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10) | 6 months | 936.2 pg/ml | Standard Deviation 1018 |
| Placebo | Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10) | baseline | 512 pg/ml | Standard Deviation 304.8 |
| Placebo | Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10) | 6 months | 514.5 pg/ml | Standard Deviation 351.1 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha | baseline | 17.8 pg/ml | Standard Deviation 6 |
| Niacin | Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha | 6 months | 20.5 pg/ml | Standard Deviation 18.2 |
| Placebo | Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha | baseline | 18.7 pg/ml | Standard Deviation 3.8 |
| Placebo | Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha | 6 months | 17.3 pg/ml | Standard Deviation 9.8 |
Secondary
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
Population: Not all subjects donated CSF. All CSF samples are recorded here.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4) | baseline | 24.6 pg/ml | Standard Deviation 2.03 |
| Niacin | Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4) | 6 months | 3.9 pg/ml | Standard Deviation 5.6 |
| Placebo | Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4) | baseline | 7.3 pg/ml | Standard Deviation 8.1 |
| Placebo | Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4) | 6 months | 6.7 pg/ml | Standard Deviation 5.09 |
Secondary
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
Population: Not all subjects donated CSF. All CSF samples are recorded here.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Cerebrospinal Fluid Changes - Interleukin 10 (IL-10) | baseline | 0.42 pg/ml | Standard Deviation 0.64 |
| Niacin | Cerebrospinal Fluid Changes - Interleukin 10 (IL-10) | 6 months | 0.09 pg/ml | Standard Deviation 0.01 |
| Placebo | Cerebrospinal Fluid Changes - Interleukin 10 (IL-10) | baseline | 0.13 pg/ml | Standard Deviation 0.16 |
| Placebo | Cerebrospinal Fluid Changes - Interleukin 10 (IL-10) | 6 months | 0.08 pg/ml | Standard Deviation 0.04 |
Secondary
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
Population: Not all subjects donated CSF. All CSF samples are recorded here.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Cerebrospinal Fluid Changes - Interleukin 6 (IL6) | baseline | 1.6 pg/ml | Standard Deviation 0.5 |
| Niacin | Cerebrospinal Fluid Changes - Interleukin 6 (IL6) | 6 months | 1.2 pg/ml | Standard Deviation 0.37 |
| Placebo | Cerebrospinal Fluid Changes - Interleukin 6 (IL6) | baseline | 1.9 pg/ml | Standard Deviation 2 |
| Placebo | Cerebrospinal Fluid Changes - Interleukin 6 (IL6) | 6 months | 1.2 pg/ml | Standard Deviation 0.4 |
Secondary
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
Population: Not all subjects donated CSF. All CSF samples are recorded here.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Cerebrospinal Fluid Changes - Interleukin 8 (IL8) | baseline | 62.9 pg/ml | Standard Deviation 5.27 |
| Niacin | Cerebrospinal Fluid Changes - Interleukin 8 (IL8) | 6 months | 91.6 pg/ml | Standard Deviation 51.2 |
| Placebo | Cerebrospinal Fluid Changes - Interleukin 8 (IL8) | baseline | 102.5 pg/ml | Standard Deviation 74.2 |
| Placebo | Cerebrospinal Fluid Changes - Interleukin 8 (IL8) | 6 months | 77.9 pg/ml | Standard Deviation 19 |
Secondary
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
Population: Not all subjects donated CSF. All CSF samples are recorded here.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta) | baseline | 14.7 pico grams per ml | Standard Deviation 5.02 |
| Niacin | Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta) | 6 months | 15.9 pico grams per ml | Standard Deviation 1.3 |
| Placebo | Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta) | baseline | 9.3 pico grams per ml | Standard Deviation 2.2 |
| Placebo | Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta) | 6 months | 7.7 pico grams per ml | Standard Deviation 4.2 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | CSF Changes in Interferon Gamma (IF-gamma) | baseline | 0.21 pg/ml | Standard Deviation 0.3 |
| Niacin | CSF Changes in Interferon Gamma (IF-gamma) | 6 months | 2.2 pg/ml | Standard Deviation 2.3 |
| Placebo | CSF Changes in Interferon Gamma (IF-gamma) | baseline | 0.39 pg/ml | Standard Deviation 0.39 |
| Placebo | CSF Changes in Interferon Gamma (IF-gamma) | 6 months | 0.89 pg/ml | Standard Deviation 0.52 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha) | baseline | 0.53 pg/ml | Standard Deviation 0.87 |
| Niacin | CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha) | 6 months | 0.23 pg/ml | Standard Deviation 0.05 |
| Placebo | CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha) | baseline | 0.18 pg/ml | Standard Deviation 0.62 |
| Placebo | CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha) | 6 months | 0.2 pg/ml | Standard Deviation 0.31 |
Secondary
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
Population: Not all subjects donated CSF. All CSF samples are recorded here.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | CSF Fluid Changes - Interleukin 1B (IL-1B) | Baseline | 0.56 pg/ml | Standard Deviation 0.8 |
| Niacin | CSF Fluid Changes - Interleukin 1B (IL-1B) | 6 months | 0.21 pg/ml | Standard Deviation 0.06 |
| Placebo | CSF Fluid Changes - Interleukin 1B (IL-1B) | Baseline | 0.28 pg/ml | Standard Deviation 0.14 |
| Placebo | CSF Fluid Changes - Interleukin 1B (IL-1B) | 6 months | 0.22 pg/ml | Standard Deviation 0.07 |
Secondary
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
Population: A subset of subjects were randomly selected for this measure and all the data is recorded here that was captured.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Macrophage Changes | baseline | 54.08 percentage of macrophages | Standard Deviation 4.08 |
| Niacin | Macrophage Changes | 6 months | 48.92 percentage of macrophages | Standard Deviation 3.9 |
| Placebo | Macrophage Changes | baseline | 56 percentage of macrophages | Standard Deviation 4.5 |
| Placebo | Macrophage Changes | 6 months | 54.5 percentage of macrophages | Standard Deviation 5.2 |
Secondary
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
Population: A subset of subjects were randomly selected for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Niacin Changes in Plasma - Niacin | baseline | 68.5 nM/L | Standard Deviation 95.96 |
| Niacin | Niacin Changes in Plasma - Niacin | 6 months | 80.83 nM/L | Standard Deviation 92.4 |
| Placebo | Niacin Changes in Plasma - Niacin | 6 months | 92.2 nM/L | Standard Deviation 59.1 |
| Placebo | Niacin Changes in Plasma - Niacin | baseline | 55.8 nM/L | Standard Deviation 88.3 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Niacin Changes in Plasma - NUA Nicotinuric Acid | at baseline | 0 nM/L | Standard Deviation 0 |
| Niacin | Niacin Changes in Plasma - NUA Nicotinuric Acid | 6 months | 313.9 nM/L | Standard Deviation 442.7 |
| Placebo | Niacin Changes in Plasma - NUA Nicotinuric Acid | 6 months | 0.38 nM/L | Standard Deviation 1.53 |
| Placebo | Niacin Changes in Plasma - NUA Nicotinuric Acid | at baseline | 4.99 nM/L | Standard Deviation 17.98 |
Secondary
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
Population: A subset of subjects were randomly selected for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Niacin Metabolite Changes in Plasma - Nicotinamide (NAM) | baseline | 0.43 uM/L | Standard Deviation 0.3 |
| Niacin | Niacin Metabolite Changes in Plasma - Nicotinamide (NAM) | 6 months | 1.07 uM/L | Standard Deviation 0.46 |
| Placebo | Niacin Metabolite Changes in Plasma - Nicotinamide (NAM) | baseline | 0.34 uM/L | Standard Deviation 0.19 |
| Placebo | Niacin Metabolite Changes in Plasma - Nicotinamide (NAM) | 6 months | 0.38 uM/L | Standard Deviation 0.15 |
Secondary
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
Population: A subset of groups were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Niacin Metabolite in Urine - Niacin | baseline | 1826.8 ng/L | Standard Deviation 663.2 |
| Niacin | Niacin Metabolite in Urine - Niacin | 6 months | 1913.8 ng/L | Standard Deviation 481 |
| Placebo | Niacin Metabolite in Urine - Niacin | baseline | 1533 ng/L | Standard Deviation 895.9 |
| Placebo | Niacin Metabolite in Urine - Niacin | 6 months | 1660.6 ng/L | Standard Deviation 431.7 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Niacin Metabolite in Urine - Nicotinuric Acid NUA | at baseline | 3565.3 ng/L | Standard Deviation 7364.8 |
| Niacin | Niacin Metabolite in Urine - Nicotinuric Acid NUA | 6 months | 20132.9 ng/L | Standard Deviation 26789.4 |
| Placebo | Niacin Metabolite in Urine - Nicotinuric Acid NUA | at baseline | 1021.8 ng/L | Standard Deviation 4538.7 |
| Placebo | Niacin Metabolite in Urine - Nicotinuric Acid NUA | 6 months | 2803.7 ng/L | Standard Deviation 8459.9 |
Secondary
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
Population: A subset of subjects were randomly selected for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Niacin Metabolites in Urine - NAM Nicotinamide | baseline | 815.5 ng/L | Standard Deviation 1155 |
| Niacin | Niacin Metabolites in Urine - NAM Nicotinamide | 6 months | 1140.3 ng/L | Standard Deviation 1058.4 |
| Placebo | Niacin Metabolites in Urine - NAM Nicotinamide | baseline | 205.8 ng/L | Standard Deviation 312.99 |
| Placebo | Niacin Metabolites in Urine - NAM Nicotinamide | 6 months | 685.4 ng/L | Standard Deviation 709.3 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Plasma Cytokines - IF Gamma | baseline | 16.2 pg/ml | Standard Deviation 15.6 |
| Niacin | Plasma Cytokines - IF Gamma | 6 months | 84.8 pg/ml | Standard Deviation 287.7 |
| Placebo | Plasma Cytokines - IF Gamma | baseline | 21 pg/ml | Standard Deviation 33.1 |
| Placebo | Plasma Cytokines - IF Gamma | 6 months | 15.95 pg/ml | Standard Deviation 19.3 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Plasma Cytokines - IL-10 | baseline | 0.41 pg/ml | Standard Deviation 0.28 |
| Niacin | Plasma Cytokines - IL-10 | 6 months | 0.5 pg/ml | Standard Deviation 0.64 |
| Placebo | Plasma Cytokines - IL-10 | 6 months | 0.41 pg/ml | Standard Deviation 0.28 |
| Placebo | Plasma Cytokines - IL-10 | baseline | 0.41 pg/ml | Standard Deviation 0.34 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Plasma Cytokines - IL1-B | baseline | 0.32 pg/ml | Standard Deviation 0.34 |
| Niacin | Plasma Cytokines - IL1-B | 6 months | 0.23 pg/ml | Standard Deviation 0.17 |
| Placebo | Plasma Cytokines - IL1-B | baseline | 0.37 pg/ml | Standard Deviation 0.41 |
| Placebo | Plasma Cytokines - IL1-B | 6 months | 0.29 pg/ml | Standard Deviation 0.28 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Plasma Cytokines - IL-6 | baseline | 5.7 pg/ml | Standard Deviation 17.8 |
| Niacin | Plasma Cytokines - IL-6 | 6 months | 2.97 pg/ml | Standard Deviation 4.25 |
| Placebo | Plasma Cytokines - IL-6 | baseline | 8.7 pg/ml | Standard Deviation 34.2 |
| Placebo | Plasma Cytokines - IL-6 | 6 months | 11.04 pg/ml | Standard Deviation 40.7 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Plasma Cytokines - IL-8 | baseline | 6.7 pg/ml | Standard Deviation 2.2 |
| Niacin | Plasma Cytokines - IL-8 | 6 months | 8.1 pg/ml | Standard Deviation 3.5 |
| Placebo | Plasma Cytokines - IL-8 | baseline | 6.2 pg/ml | Standard Deviation 2.1 |
| Placebo | Plasma Cytokines - IL-8 | 6 months | 6.6 pg/ml | Standard Deviation 2.8 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Plasma Cytokines - IP-10 | baseline | 443.3 pg/ml | Standard Deviation 197.3 |
| Niacin | Plasma Cytokines - IP-10 | 6 months | 542.1 pg/ml | Standard Deviation 295.8 |
| Placebo | Plasma Cytokines - IP-10 | baseline | 402.7 pg/ml | Standard Deviation 252.5 |
| Placebo | Plasma Cytokines - IP-10 | 6 months | 355.4 pg/ml | Standard Deviation 158.6 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Plasma Cytokines - MCP-4 | baseline | 112.3 pg/ml | Standard Deviation 73.8 |
| Niacin | Plasma Cytokines - MCP-4 | 6 months | 106.4 pg/ml | Standard Deviation 44 |
| Placebo | Plasma Cytokines - MCP-4 | baseline | 104.6 pg/ml | Standard Deviation 35.7 |
| Placebo | Plasma Cytokines - MCP-4 | 6 months | 90.7 pg/ml | Standard Deviation 41.3 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Plasma Cytokines - MIP1-alpha | baseline | 23.3 pg/ml | Standard Deviation 20.5 |
| Niacin | Plasma Cytokines - MIP1-alpha | 6 months | 23.2 pg/ml | Standard Deviation 9.3 |
| Placebo | Plasma Cytokines - MIP1-alpha | baseline | 42.1 pg/ml | Standard Deviation 116.7 |
| Placebo | Plasma Cytokines - MIP1-alpha | 6 months | 38.9 pg/ml | Standard Deviation 75.5 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Plasma Cytokines - MIP1-beta | baseline | 69.3 pg/ml | Standard Deviation 26.1 |
| Niacin | Plasma Cytokines - MIP1-beta | 6 months | 65.5 pg/ml | Standard Deviation 34.5 |
| Placebo | Plasma Cytokines - MIP1-beta | baseline | 65.8 pg/ml | Standard Deviation 29.8 |
| Placebo | Plasma Cytokines - MIP1-beta | 6 months | 56 pg/ml | Standard Deviation 24 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Plasma Cytokines - TNF-alpha | baseline | 2.05 pg/ml | Standard Deviation 4.7 |
| Niacin | Plasma Cytokines - TNF-alpha | 6 months | 2.26 pg/ml | Standard Deviation 5.2 |
| Placebo | Plasma Cytokines - TNF-alpha | baseline | 0.96 pg/ml | Standard Deviation 0.29 |
| Placebo | Plasma Cytokines - TNF-alpha | 6 months | 1.0 pg/ml | Standard Deviation 0.31 |
Secondary
Plasma Levels - Serotonin
Plasma serotonin levels
Time frame: at baseline and after 6 months
Population: a subset of the groups were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin | Plasma Levels - Serotonin | baseline | 84.2 mg/dL | Standard Deviation 68.2 |
| Niacin | Plasma Levels - Serotonin | 6 months | 83 mg/dL | Standard Deviation 75.2 |
| Placebo | Plasma Levels - Serotonin | baseline | 89.6 mg/dL | Standard Deviation 60.5 |
| Placebo | Plasma Levels - Serotonin | 6 months | 64.2 mg/dL | Standard Deviation 44.5 |