Cognitive Symptom, Covid19, Sequelae of; Infection
Conditions
Keywords
Niagen, vitamin B3, Long-COVID, Long-haulers, Dietary supplement
Brief summary
The study will assess whether Niagen, a safe dietary supplement, improves recovery of COVID-19 related symptoms in individuals who were infected at least 2 months prior to study entry (Long-COVID Long-haulers). 60% of participants will receive Niagen and 40% will receive PBO. Outcomes will consist of standardized cognitive, neuropsychiatric, physical, functional and biomarker assessments.
Detailed description
This study will recruit people who were infected with COVID-19 at least 2 months ago and continue to experience symptoms related to infection. Initially thought to be an acute illness like the flu, resulting in death for some or full recovery in most, scientists and clinicians are now appreciating that substantial numbers of COVID-19 illness survivors experience persistent, significant and sometimes disabling symptoms. Variously called Long-COVID, COVID long-haulers, or chronic COVID syndrome, some of the most prominent symptoms are neurologic and neuropsychiatric, including cognitive impairment ('brain fog'), headache, fatigue, muscle aches and weakness, shortness of breath, hair loss and pain, among others. In this research study the investigators want to learn about whether taking Niagen (also known as Nicotinamide riboside, or NR), a daily supplement containing a form of Vitamin B3, can improve recovery of cognitive function, mood, and physical health in individuals who were infected with COVID-19 and continue to experience brain fog and other neurological and physical symptoms. The investigators think that this supplement may help improve thinking skills and other symptoms, and improve quality of life, in individuals who had COVID-19. Participants will complete the following at baseline and every 5 weeks: 1) a standard cognitive battery and subjective cognitive complaints scales; 2) mood measures; 3) assessments of physical functioning, as well as of other common COVID-19-related symptoms; 4) blood draw; and 5) 2 optional MRIs. Participants will also wear a Fitbit and complete questionnaires to assess sleep and physical activity.
Interventions
DRUGNiagen
The intervention consists of taking Niagen and completing all tasks divided into 6 visits.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blinded, randomized, parallel group, placebo-controlled design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* History of SARS-CoV-2 PCR+ at least 2 months prior to study entry; * SARS-CoV-2 negative (PCR) at study entry; * Persistent cognitive difficulties (esp. brain fog) that began around the time of the acute COVID-19; * At least two neurological and/or physical symptoms that started with COVID-19 infection and are ongoing at study entry, including fatigue, weakness, headache, loss of smell, tingling/numbness, shortness of breath, loss of appetite, palpitations/tachycardia, hair loss, musculoskeletal and/or chest pain; * Willing and able to consent, complete all assessment and study procedures; * Not pregnant or lactating.
Exclusion criteria
* Any specific central nervous system disease history (e.g. major clinical stroke, brain tumor, normal pressure hydrocephalus, etc); * Clinically significant unstable medical condition that could affect safety or compliance with the study; * Was intubated due to COVID-19; * Major active or chronic unstable psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year; * History of alcohol or other substance abuse or dependence within the past two years; * Any significant systemic illness or medical condition that could affect safety or compliance with study; * Current use of medications with psychoactive properties that may be deleteriously affecting cognition; * Any known hypersensitivity to nicotinamide riboside, or its principal metabolite, nicotinamide mononucleotide; * Use of other investigational agents or interventions one month prior to entry and for the duration of the trial; * If participating in the optional magnetic resonance imaging (MRI) sub-study: Any contraindication to undergo MRI; * Pregnant women or women who are planning to become pregnant within 7 months from study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Niagen on NAD+ and Cognitive Functioning | Baseline, Week 10 and Week 20 | Cognitive outcomes were assessed using the Everyday Cognition (ECog) scale, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and the Trail Making Test B (TMT-B). The ECog total score ranges from 39 to 156, and individual domain scores range from 1 to 4. Higher scores indicate greater subjective cognitive decline since COVID-19 infection. Individual RBANS index scores range from 40 to 160, and the Sum of Index Scores (sum of five index scores) ranges from 200 to 800. Higher index scores reflect better cognitive performance. The TMT-B score is the completion time in seconds, with a maximum time of 5 minutes. A lower time is indicative of a better performance. Change scores reflect the difference from Baseline to Week 10, and from Week 10 to Week 20. Positive change scores on the ECog indicate worsening subjective cognitive decline. Positive change scores on the RBANS indicate improvement. Positive change scores in the TMT-B represent worsening performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Niagen on NAD+ and Depression Symptoms | Baseline, Week 10 and Week 20 | Depression symptoms were assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire measuring severity of depression symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depression. Values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20. |
| Effect of Niagen on NAD+ and Anxiety Symptoms | Baseline, Week 10 and Week 20 | Anxiety symptoms were assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire measuring severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating more severe anxiety. Values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20. |
| Effect of Niagen on NAD+ and Other COVID-related Symptoms | Baseline, Week 10 and Week 20 | Fatigue was assessed using the Fatigue Severity Scale (FSS), a 9-item self-report measure with scores ranging from 1 to 7; higher scores indicate greater fatigue severity. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report measure with scores ranging from 0 to 21; higher scores indicate poorer sleep quality. All values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled between August 2021 and September 2023. They were recruited using flyers posted at Massachusetts General Hospital (main and Charlestown campuses), Partners Rally for Research, community events, physician referrals, and outreach to local institutions. Eligibility was assessed via telephone interview and an in-person screening visit.
Pre-assignment details
72 participants provided informed consent and completed an in-person screening visit. Eleven participants were deemed ineligible based on screening assessments and did not proceed. The remaining 61 participants entered a two-week placebo lead-in phase, during which 3 participants withdrew from the study. A total of 58 participants completed the lead-in phase, attended the baseline visit, and were randomized to study intervention.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants randomized to the placebo group received placebo capsules twice daily for 10 weeks following a two-week placebo lead-in period. After the initial 10 weeks, participants crossed over to receive NR (TruNiagen, Chromadex) 1000 mg twice daily for an additional 10 weeks. Dosing was double-blinded. Participants completed assessments of cognitive, neuropsychiatric, physical, functional, and biomarker outcomes, along with actigraphy monitoring. | 21 |
| Niagen Participants randomized to the Niagen group received NR (TruNiagen, Chromadex) 1000 mg twice daily for 20 weeks following a two-week placebo lead-in period. Dosing was double-blinded. Participants completed assessments of cognitive, neuropsychiatric, physical, functional, and biomarker outcomes, along with actigraphy monitoring. | 37 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Lead-in Phase | No longer eligible | 11 | 0 | 0 |
| Lead-in Phase | Withdrawal by Subject | 3 | 0 | 0 |
| Randomized Phase | Adverse Event | 0 | 1 | 4 |
| Randomized Phase | Lost to Follow-up | 0 | 1 | 5 |
| Randomized Phase | Met an exclusion criteria during the study (e.g., re-infected with COVID-19, started new medication) | 0 | 2 | 8 |
| Randomized Phase | Withdrawal by Subject | 0 | 0 | 5 |
Baseline characteristics
| Characteristic | Niagen | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 47.05 Years STANDARD_DEVIATION 13.79 | 43.76 Years STANDARD_DEVIATION 12.72 | 45.86 Years STANDARD_DEVIATION 13.4 |
| Education Associate or Technical Degree | 6 Participants | 0 Participants | 6 Participants |
| Education College | 21 Participants | 8 Participants | 29 Participants |
| Education High School/GED | 0 Participants | 1 Participants | 1 Participants |
| Education Professional Studies | 6 Participants | 11 Participants | 17 Participants |
| Education Some College | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 20 Participants | 53 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 | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 34 Participants | 18 Participants | 52 Participants |
| Region of Enrollment United States | 37 Participants | 21 Participants | 58 Participants |
| Sex: Female, Male Female | 26 Participants | 16 Participants | 42 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 21 | 0 / 37 |
| other Total, other adverse events | 1 / 72 | 19 / 21 | 25 / 37 |
| serious Total, serious adverse events | 0 / 72 | 0 / 21 | 1 / 37 |
Outcome results
Primary
Effect of Niagen on NAD+ and Cognitive Functioning
Cognitive outcomes were assessed using the Everyday Cognition (ECog) scale, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and the Trail Making Test B (TMT-B). The ECog total score ranges from 39 to 156, and individual domain scores range from 1 to 4. Higher scores indicate greater subjective cognitive decline since COVID-19 infection. Individual RBANS index scores range from 40 to 160, and the Sum of Index Scores (sum of five index scores) ranges from 200 to 800. Higher index scores reflect better cognitive performance. The TMT-B score is the completion time in seconds, with a maximum time of 5 minutes. A lower time is indicative of a better performance. Change scores reflect the difference from Baseline to Week 10, and from Week 10 to Week 20. Positive change scores on the ECog indicate worsening subjective cognitive decline. Positive change scores on the RBANS indicate improvement. Positive change scores in the TMT-B represent worsening performance.
Time frame: Baseline, Week 10 and Week 20
Population: Only participants with complete outcome data at both timepoints relevant to a given change score were included in the analysis. Participants with missing data at either timepoint were excluded from the analysis for that specific outcome. As a result, the number of participants analyzed is lower than the total number randomized in each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Attention (Baseline to Week 10) | -0.150 units on a scale | Standard Deviation 0.633 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Visualspatial (Baseline to Week 10) | 0.103 units on a scale | Standard Deviation 0.564 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Attention (Week 10 to Week 20) | -0.028 units on a scale | Standard Deviation 0.808 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Sum of Index Scores (Baseline to Week 10) | 10.600 units on a scale | Standard Deviation 29.819 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Memory (Week 10 to Week 20) | 0.068 units on a scale | Standard Deviation 0.515 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Sum of Index Scores (Week 10 to Week 20) | -8.111 units on a scale | Standard Deviation 26.169 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Immediate Memory (Baseline to Week 10) | 5.800 units on a scale | Standard Deviation 13.808 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Visualspatial (Week 10 to Week 20) | -0.132 units on a scale | Standard Deviation 0.878 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Immediate Memory (Week 10 to Week 20) | -4.167 units on a scale | Standard Deviation 11.784 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Total (Baseline to Week 10) | -0.104 units on a scale | Standard Deviation 0.37 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Delayed Memory (Baseline to Week 10) | 4.920 units on a scale | Standard Deviation 11.42 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Planning (Baseline to Week 10) | -0.130 units on a scale | Standard Deviation 0.643 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Delayed Memory (Week 10 to Week 20) | 0.944 units on a scale | Standard Deviation 8.047 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Language (Baseline to Week 10) | -0.216 units on a scale | Standard Deviation 0.415 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Attention (Baseline to Week 10) | 4.080 units on a scale | Standard Deviation 11.358 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Planning (Week 10 to Week 20) | 0.081 units on a scale | Standard Deviation 0.642 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Attention (Week 10 to Week 20) | -2.056 units on a scale | Standard Deviation 12.822 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Memory (Baseline to Week 10) | -0.222 units on a scale | Standard Deviation 0.422 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Language (Baseline to Week 10) | -2.720 units on a scale | Standard Deviation 12.674 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Language (Week 10 to Week 20) | -1.833 units on a scale | Standard Deviation 14.284 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Organization (Baseline to Week 10) | 0.060 units on a scale | Standard Deviation 1.014 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Visuospatial (Baseline to Week 10) | -1.560 units on a scale | Standard Deviation 13.058 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Visuospatial (Week 10 to Week 20) | 1.056 units on a scale | Standard Deviation 14.198 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Language (Week 10 to Week 20) | 0.068 units on a scale | Standard Deviation 0.528 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | Trail-Making-Test B (Baseline to Week 10) | -10.164 units on a scale | Standard Deviation 21.456 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Organization (Week 10 to Week 20) | -0.179 units on a scale | Standard Deviation 1.072 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | Trail-Making-Test B (Week 10 to Week 20) | -3.525 units on a scale | Standard Deviation 20.103 |
| Niagen | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Total (Week 10 to Week 20) | -0.014 units on a scale | Standard Deviation 0.548 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | Trail-Making-Test B (Week 10 to Week 20) | -5.856 units on a scale | Standard Deviation 19.148 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Sum of Index Scores (Week 10 to Week 20) | -13.556 units on a scale | Standard Deviation 40.441 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Language (Baseline to Week 10) | -0.222 units on a scale | Standard Deviation 15.653 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Visuospatial (Baseline to Week 10) | -1.556 units on a scale | Standard Deviation 12.538 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Total (Baseline to Week 10) | -0.214 units on a scale | Standard Deviation 0.37 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Total (Week 10 to Week 20) | -0.147 units on a scale | Standard Deviation 0.236 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Memory (Baseline to Week 10) | -0.285 units on a scale | Standard Deviation 0.564 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Memory (Week 10 to Week 20) | -0.139 units on a scale | Standard Deviation 0.498 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Language (Baseline to Week 10) | -0.289 units on a scale | Standard Deviation 0.378 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Language (Week 10 to Week 20) | -0.088 units on a scale | Standard Deviation 0.321 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Visualspatial (Baseline to Week 10) | -0.203 units on a scale | Standard Deviation 0.46 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Visualspatial (Week 10 to Week 20) | -0.028 units on a scale | Standard Deviation 0.283 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Planning (Baseline to Week 10) | -0.211 units on a scale | Standard Deviation 0.478 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Planning (Week 10 to Week 20) | -0.089 units on a scale | Standard Deviation 0.293 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Organization (Baseline to Week 10) | -0.100 units on a scale | Standard Deviation 0.517 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Organization (Week 10 to Week 20) | -0.278 units on a scale | Standard Deviation 0.423 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Attention (Baseline to Week 10) | -0.139 units on a scale | Standard Deviation 0.479 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Sum of Index Scores (Baseline to Week 10) | 10.000 units on a scale | Standard Deviation 23.314 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Immediate Memory (Baseline to Week 10) | 4.944 units on a scale | Standard Deviation 12.085 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Immediate Memory (Week 10 to Week 20) | -6.389 units on a scale | Standard Deviation 13.954 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Delayed Memory (Baseline to Week 10) | 2.167 units on a scale | Standard Deviation 9.787 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Delayed Memory (Week 10 to Week 20) | -3.111 units on a scale | Standard Deviation 12.925 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Attention (Baseline to Week 10) | 5.333 units on a scale | Standard Deviation 12.825 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Attention (Week 10 to Week 20) | -0.389 units on a scale | Standard Deviation 12.93 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Language (Week 10 to Week 20) | -3.556 units on a scale | Standard Deviation 16.639 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | RBANS Visuospatial (Week 10 to Week 20) | 0.167 units on a scale | Standard Deviation 13.143 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | Trail-Making-Test B (Baseline to Week 10) | -6.574 units on a scale | Standard Deviation 14.272 |
| Placebo | Effect of Niagen on NAD+ and Cognitive Functioning | ECog Attention (Week 10 to Week 20) | -0.347 units on a scale | Standard Deviation 0.486 |
Secondary
Effect of Niagen on NAD+ and Anxiety Symptoms
Anxiety symptoms were assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire measuring severity of anxiety symptoms. Total scores range from 0 to 63, with higher scores indicating more severe anxiety. Values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20.
Time frame: Baseline, Week 10 and Week 20
Population: Only participants with complete outcome data at both timepoints relevant to a given change score were included in the analysis. Participants with missing data at either timepoint were excluded from the analysis for that specific outcome. As a result, the number of participants analyzed is lower than the total number randomized in each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niagen | Effect of Niagen on NAD+ and Anxiety Symptoms | BAI (Baseline to Week 10) | -0.840 score on a scale | Standard Deviation 7.301 |
| Niagen | Effect of Niagen on NAD+ and Anxiety Symptoms | BAI (Week 10 to Week 20) | -0.167 score on a scale | Standard Deviation 5.628 |
| Placebo | Effect of Niagen on NAD+ and Anxiety Symptoms | BAI (Baseline to Week 10) | -1.333 score on a scale | Standard Deviation 6.589 |
| Placebo | Effect of Niagen on NAD+ and Anxiety Symptoms | BAI (Week 10 to Week 20) | -1.778 score on a scale | Standard Deviation 4.387 |
Secondary
Effect of Niagen on NAD+ and Depression Symptoms
Depression symptoms were assessed using the Beck Depression Inventory (BDI), a 21-item self-report questionnaire measuring severity of depression symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depression. Values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20.
Time frame: Baseline, Week 10 and Week 20
Population: Only participants with complete outcome data at both timepoints relevant to a given change score were included in the analysis. Participants with missing data at either timepoint were excluded from the analysis for that specific outcome. As a result, the number of participants analyzed is lower than the total number randomized in each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niagen | Effect of Niagen on NAD+ and Depression Symptoms | BDI (Baseline to Week 10) | -1.360 score on a scale | Standard Deviation 5.529 |
| Niagen | Effect of Niagen on NAD+ and Depression Symptoms | BDI (Week 10 to Week 20) | 0.167 score on a scale | Standard Deviation 4.301 |
| Placebo | Effect of Niagen on NAD+ and Depression Symptoms | BDI (Baseline to Week 10) | 0.167 score on a scale | Standard Deviation 5.659 |
| Placebo | Effect of Niagen on NAD+ and Depression Symptoms | BDI (Week 10 to Week 20) | -2.111 score on a scale | Standard Deviation 4.945 |
Secondary
Effect of Niagen on NAD+ and Other COVID-related Symptoms
Fatigue was assessed using the Fatigue Severity Scale (FSS), a 9-item self-report measure with scores ranging from 1 to 7; higher scores indicate greater fatigue severity. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report measure with scores ranging from 0 to 21; higher scores indicate poorer sleep quality. All values represent mean change scores from Baseline to Week 10 and from Week 10 to Week 20.
Time frame: Baseline, Week 10 and Week 20
Population: Only participants with complete outcome data at both timepoints relevant to a given change score were included in the analysis. Participants with missing data at either timepoint were excluded from the analysis for that specific outcome. As a result, the number of participants analyzed is lower than the total number randomized in each group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niagen | Effect of Niagen on NAD+ and Other COVID-related Symptoms | FSS Total Fatigue (Baseline to Week 10) | -3.400 score on a scale | Standard Deviation 7.708 |
| Niagen | Effect of Niagen on NAD+ and Other COVID-related Symptoms | FSS Total Fatigue (Week 10 to Week 20) | 3.444 score on a scale | Standard Deviation 9.083 |
| Placebo | Effect of Niagen on NAD+ and Other COVID-related Symptoms | FSS Total Fatigue (Baseline to Week 10) | -0.389 score on a scale | Standard Deviation 8.417 |
| Placebo | Effect of Niagen on NAD+ and Other COVID-related Symptoms | FSS Total Fatigue (Week 10 to Week 20) | -4.278 score on a scale | Standard Deviation 4.775 |