Trial Outcomes & Findings for Safety and Efficacy of Cunermuspir on Energy, Strength, and Fatigue in Patients With Nerve or Muscle Pain (NCT NCT04737278)

NCT ID: NCT04737278

Last Updated: 2021-04-20

Results Overview

Quality of life was assessed by using the Individualized Neuromuscular Quality of Life Questionnaire (INQoL) Answers to symptom questions are scored from 0 to 6 or 7 with 0 being "none at all" and and 6 to 7 being "an extreme amount" There are three questions regarding pain. The pain score is (a+b+c)/19 x100. The higher the score, the greater the symptom impact.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 56 participants
• Primary outcome timeframe: baseline and 28 days after enrollment
• Results posted on: 2021-04-20

Participant Flow

A total of 56 met the enrollment requirements. Of these only 49 completed the study

Participant milestones

Measure	Cunermuspir Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Overall Study STARTED	28	28
Overall Study COMPLETED	24	25
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Cunermuspir Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	1	1
Overall Study failure to complete questionnaire	1	1

Baseline Characteristics

Safety and Efficacy of Cunermuspir on Energy, Strength, and Fatigue in Patients With Nerve or Muscle Pain

Baseline characteristics by cohort

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	45.4 years STANDARD_DEVIATION 13.6 • n=5 Participants	48.2 years STANDARD_DEVIATION 10.4 • n=7 Participants	46.8 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment Canada	28 participants n=5 Participants	28 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.

Quality of life was assessed by using the Individualized Neuromuscular Quality of Life Questionnaire (INQoL) Answers to symptom questions are scored from 0 to 6 or 7 with 0 being "none at all" and and 6 to 7 being "an extreme amount" There are three questions regarding pain. The pain score is (a+b+c)/19 x100. The higher the score, the greater the symptom impact.

Outcome measures

Measure	Cunermuspir n=24 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=25 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Neuromuscular Symptoms baseline	36.5 score on a scale Standard Error 16.4	43.5 score on a scale Standard Error 21.1
Neuromuscular Symptoms Day 28	28.5 score on a scale Standard Error 18.6	32.7 score on a scale Standard Error 23.0

PRIMARY outcome

Timeframe: baseline and 28 days after enrollment

Population: ATP isolated from platelets. Some samples were not used for analysis due to contamination with red blood cells.

Platelet ATP levels were measured as previously published in the literature.

Outcome measures

Measure	Cunermuspir n=21 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=25 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Platelet ATP day 28	59.2 nmol / E9 Platelets Standard Deviation 20.1	51.2 nmol / E9 Platelets Standard Deviation 15.0
Platelet ATP baseline	43.6 nmol / E9 Platelets Standard Deviation 16.4	42 nmol / E9 Platelets Standard Deviation 13.1

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.

Physical function in performing household chores was assessed using the Revised Symptom Impact Questionnaire (SQIR) For each household chore participants are asked to check 1 of 11 boxes between "no difficulty" and "extremely difficult" No difficulty is scored as 0 and extreme difficulty with the task is scored as 10. The higher the score, the more difficulty experienced performing the chore. Friend & Bennett Arthritis Res & Therapy 2011. Household chores are just one module with 9 questions for a maximum of 90 points. These scores are summed and divided by 3. Module 2 relates to the emotional impact with only two questions for a total of 20 points. Module 3 relates to physical symptoms with a total of ten questions worth a maximum of 100 points. This score is divided by 2. The three modules are summed for a total impact score of 100 points. A score of 0 indicates absolutely no impact and a score of 100 the greatest possible impact.

Outcome measures

Measure	Cunermuspir n=24 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=25 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Household Chores and Neuro Muscular Sumptoms day 28	16.7 units on a scale Standard Error 10.9	29.3 units on a scale Standard Error 28.7
Household Chores and Neuro Muscular Sumptoms baseline	27.6 units on a scale Standard Error 16.8	34.9 units on a scale Standard Error 16.9

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.

Cognition is the mental process of knowing, including aspects such as awareness, perception, reasoning, and judgment. The mini-mental state exam (MMSE) puts a number to "cognition." Any score of 24 or more out of a total 30 points is considered normal cognition. A test taker may be asked to orientate in space and time by recalling aspects of the physical location as well as month, day, year, and perhaps season. Simple mathematical calculations like counting backwards from 100 by seven may also be included. A complex command such as redrawing geometric figures scores six points in this exam. Since none of the participates were cognitively impaired, the investigators decided to make obtaining a perfect score on this exam an outcome measure.

Outcome measures

Measure	Cunermuspir n=24 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=25 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Cognition baseline	18 participants with perfect score	16 participants with perfect score
Cognition day 28	22 participants with perfect score	18 participants with perfect score

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

heart rate is measured in beats per minute

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Heart Rate baseline	70.3 beats per minute Standard Error 10.8	68.2 beats per minute Standard Error 8.1
Heart Rate day 28	68.3 beats per minute Standard Error 9.7	69.7 beats per minute Standard Error 9.4

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

The diastolic blood pressure was measured in mm Hg

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Diastolic Blood Pressure baseline	70.5 mm Hg Standard Error 6.4	75.0 mm Hg Standard Error 9.4
Diastolic Blood Pressure day 28	69.3 mm Hg Standard Error 7.3	74.6 mm Hg Standard Error 7.3

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment.

Population: For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

Systolic blood pressure was measured in mm Hg

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Systolic Blood Pressure baseline	111.7 mm Hg Standard Error 10.6	114.6 mm Hg Standard Error 13.1
Systolic Blood Pressure day 28	109.5 mm Hg Standard Error 15.8	112.3 mm Hg Standard Error 11.2

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment.

Population: For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes measured in g/L blood

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Hemoglobin baseline	140.3 g/L Standard Error 12.9	141.3 g/L Standard Error 12.4
Hemoglobin day 28	142.2 g/L Standard Error 14.3	141.0 g/L Standard Error 12.0

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in the fraction of whole blood occupied by red blood cells measured as L/L

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Hematocrit baseline	0.411 L/L Standard Error 0.034	0.416 L/L Standard Error 0.032
Hematocrit day 28	0.416 L/L Standard Error 0.038	0.415 L/L Standard Error 0.031

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in white blood cells (WBC) measured in units of 10^9 per liter blood

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
WBC baseline	5.93 10^9 cells/L Standard Error 1.57	5.82 10^9 cells/L Standard Error 1.50
WBC day 28	5.88 10^9 cells/L Standard Error 1.81	6.00 10^9 cells/L Standard Error 1.34

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in red blood cells (RBC) measured in units of 10^12 per liter blood

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
RBC baseline	4.76 10^12 cells/L Standard Error 0.38	4.74 10^12 cells/L Standard Error 0.38
RBC day 28	4.82 10^12 cells/L Standard Error 0.41	4.73 10^12 cells/L Standard Error 0.38

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.

changes in mean corpuscular volume (MCV) measured in units of fL

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
MCV baseline	86.2 fempto liter per cell Standard Error 3.9	87.7 fempto liter per cell Standard Error 3.1
MCV day 28	86.4 fempto liter per cell Standard Error 4.3	87.7 fempto liter per cell Standard Error 3.1

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
MCH baseline	29.5 pg per cell Standard Error 1.64	29.81 pg per cell Standard Error 1.36
MCH day 28	29.48 pg per cell Standard Error 1.69	29.86 pg per cell Standard Error 1.29

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
MCHC baseline	342.4 g/L Standard Error 8.2	339.9 g/L Standard Error 7.8
MCHC day 28	341.2 g/L Standard Error 6.4	340.5 g/L Standard Error 5.7

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in the RBC distribution width (RDW) are reported in units of percentage (%)

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
RDW baseline	13.78 red cell distribution width % Standard Error 0.70	13.80 red cell distribution width % Standard Error 0.50
RDW day 28	13.77 red cell distribution width % Standard Error 0.63	13.93 red cell distribution width % Standard Error 0.58

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: By day 28 three participants were lost to followup: two in the Cunermuspir group and one in the placebo group. There were issues in handling of one platelet sample in the Cunermuspir group. This brings the number in the Cunermuspir group down to 25 on day 28. For technical reasons, platelet data are missing for subject 021. All other blood cell data are present in this report of data.

changes in the platelet counts are reported in units of 10^9 per liter blood

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Platelets baseline	250 10^9 platelets/L Standard Error 62	266 10^9 platelets/L Standard Error 71
Platelets day 28	255 10^9 platelets/L Standard Error 65	269 10^9 platelets/L Standard Error 69

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in neutrophils are reported in units of 10^9 per liter blood

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Neutrophils baseline	3.28 10^9 cells/L Standard Error 1.06	3.35 10^9 cells/L Standard Error 1.13
Neutrophils day 28	3.15 10^9 cells/L Standard Error 1.19	3.60 10^9 cells/L Standard Error 1.13

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in lymphocytes are reported in units of 10^9 per liter blood

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Lymphocyte baseline	2.01 10^9 cells/L Standard Error 0.64	1.83 10^9 cells/L Standard Error 0.51
Lymphocyte day 28	2.04 10^9 cells/L Standard Error 0.72	1.74 10^9 cells/L Standard Error 0.51

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in monocytes are reported in units of 10^9 per liter blood

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Monocyte baseline	0.450 10^9 cells/L Standard Error 0.137	0.475 10^9 cells/L Standard Error 0.140
Monocyte day 28	0.473 10^9 cells/L Standard Error 0.176	0.500 10^9 cells/L Standard Error 0.124

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in eosinophils are reported in units of 10^9 cells per liter blood

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Eosinophil day 28	0.181 10^9 cells/L Standard Error 0.110	0.130 10^9 cells/L Standard Error 0.072
Eosinophil baseline	0.154 10^9 cells/L Standard Error 0.074	0.143 10^9 cells/L Standard Error 0.063

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in basophils are reported in units of 10^9 cells per liter blood

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Basophil baseline	0.0107 10^9 cells/L Standard Error 0.0315	0.0071 10^9 cells/L Standard Error 0.0262
Basophil day 28	0.0077 10^9 cells/L Standard Error 0.0272	0.0074 10^9 cells/L Standard Error 0.0267

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
NLR baseline	1.77 dimensionaless units Standard Error 0.15	1.90 dimensionaless units Standard Error 0.13
NLR day 28	1.67 dimensionaless units Standard Error 0.14	2.24 dimensionaless units Standard Error 0.19

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: In this population the initial screening was considered the baseline for all blood chemistry parameters. Three of the the participants were lost to followup or withdrew from the study

changes in blood glucose are reported in units of mmol per liter

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Glucose baseline	5.12 mmol/L Standard Error 0.55	5.30 mmol/L Standard Error 0.42
Glucose day 28	5.25 mmol/L Standard Error 0.44	5.24 mmol/L Standard Error 0.48

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in renal function as measured by blood urea are reported in units of mmol per liter

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Urea baseline	5.16 mmol/L Standard Error 1.13	5.33 mmol/L Standard Error 1.25
Urea day 28	5.05 mmol/L Standard Error 1.57	5.26 mmol/L Standard Error 1.08

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in creatinine are reported in units of micromol per liter

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Creatinine baseline	72.2 micromol/L Standard Error 11.6	72.9 micromol/L Standard Error 16.0
Creatinine day 28	72.3 micromol/L Standard Error 13.7	73.7 micromol/L Standard Error 15.0

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m^2

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
eGFR baseline	90.4 mL/min/1.73 m^2 Standard Error 17.3	88.8 mL/min/1.73 m^2 Standard Error 16.2
eGFR day 28	91.2 mL/min/1.73 m^2 Standard Error 18.3	85.9 mL/min/1.73 m^2 Standard Error 15.7

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in plasma sodium are reported in units of mmol per liter, reference range is 133-146 mEq/L, same as mM/L bloodbook.com

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Sodium baseline	143.39 mmol/L Standard Error 2.25	143.14 mmol/L Standard Error 2.16
Sodium day 28	142.62 mmol/L Standard Error 2.47	141.89 mmol/L Standard Error 2.12

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: The study sponsor is of the opinion that these participants were dehydrated when they started the study. They were instructed to drink more water. Three of the 56 that started the study were lost to followup or withdrew.

changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Potassium day 28	4.44 mmol/L Standard Error 0.43	4.39 mmol/L Standard Error 0.39
Potassium baseline	4.86 mmol/L Standard Error 0.45	4.84 mmol/L Standard Error 0.45

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Enrollment pre-screening values are taken as the baseline. The study sponsor was of the opinion that these participants started the study dehydrated. Of the original 56 three were lost to followup or withdrew.

changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Chloride baseline	106.14 mmol/L Standard Error 2.12	106.43 mmol/L Standard Error 2.27
Chloride day 28	105.08 mmol/L Standard Error 2.23	105.15 mmol/L Standard Error 1.99

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in total bilirubin are reported in units of micro moles per liter. Direct: up to 0.4 mg/dL, Total: up to 1.0 mg/dL bloodbook.com, Converts to 6.84-17.1 micro moles per liter. https://unitslab.com/node/37

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Bilirubin baseline	11.0 micromol/L Standard Error 5.9	9.3 micromol/L Standard Error 3.5
Bilirubin day 28	11.2 micromol/L Standard Error 5.9	9.9 micromol/L Standard Error 4.3

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in the liver enzyme alanine aminotransferase (ALT) in the blood are reported as units per liter Reference range 1 - 21 units/L bloodbook.com

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
ALT day 28	28.2 U/L Standard Error 15.5	28.4 U/L Standard Error 15.4
ALT baseline	27.6 U/L Standard Error 12.8	28.5 U/L Standard Error 16.3

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in the liver enzyme aspartate aminotransferase (AST) in the blood are reported as units per liter Reference range 7 - 27 units/L bloodbook.com

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
AST baseline	23.0 U/L Standard Error 4.9	23.1 U/L Standard Error 6.3
AST day 28	24.2 U/L Standard Error 6.2	25.8 U/L Standard Error 9.5

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures

changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
GGT baseline	20.9 U/L Standard Error 13.6	28.6 U/L Standard Error 36.6
GGT day 28	24.0 U/L Standard Error 18.1	25.6 U/L Standard Error 23.0

SECONDARY outcome

Timeframe: baseline and 28 days after enrollment

Population: Of the 56 enrolled in the study three were lost to followup or dropped out.

changes in copper concentration in the blood are reported in units of micro moles per liter

Outcome measures

Measure	Cunermuspir n=28 Participants Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=28 Participants Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Copper baseline	16.18 U/L Standard Error 2.42	17.62 U/L Standard Error 2.51
Copper day 28	16.6 U/L Standard Error 2.8	17.57 U/L Standard Error 2.89

Adverse Events

Cunermuspir

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cunermuspir n=26 participants at risk；n=28 participants at risk Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days. Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide	Placebo n=27 participants at risk；n=28 participants at risk Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm Placebo: same non-medical ingredients and encapsulation as Intervention 1
Gastrointestinal disorders nasea	15.4% 4/26 • Number of events 4 • 28 days All treatment--emergent adverse events (AEs) are listed and MedDRA--coded to obtain the MedDRA Preferred Term and Organ System ("body system"). The nature, incidence, severity and causality were AEs were summarized in a frequency table, by body system and treatment. The proportion of subjects experiencing one or more AEs were compared between groups, separately for each body system and for all AEs combined.	11.1% 3/27 • Number of events 3 • 28 days All treatment--emergent adverse events (AEs) are listed and MedDRA--coded to obtain the MedDRA Preferred Term and Organ System ("body system"). The nature, incidence, severity and causality were AEs were summarized in a frequency table, by body system and treatment. The proportion of subjects experiencing one or more AEs were compared between groups, separately for each body system and for all AEs combined.
Infections and infestations seasonal respiratory infections	7.7% 2/26 • Number of events 2 • 28 days All treatment--emergent adverse events (AEs) are listed and MedDRA--coded to obtain the MedDRA Preferred Term and Organ System ("body system"). The nature, incidence, severity and causality were AEs were summarized in a frequency table, by body system and treatment. The proportion of subjects experiencing one or more AEs were compared between groups, separately for each body system and for all AEs combined.	14.8% 4/27 • Number of events 5 • 28 days All treatment--emergent adverse events (AEs) are listed and MedDRA--coded to obtain the MedDRA Preferred Term and Organ System ("body system"). The nature, incidence, severity and causality were AEs were summarized in a frequency table, by body system and treatment. The proportion of subjects experiencing one or more AEs were compared between groups, separately for each body system and for all AEs combined.
Skin and subcutaneous tissue disorders moderate dermatitis	3.8% 1/26 • Number of events 1 • 28 days All treatment--emergent adverse events (AEs) are listed and MedDRA--coded to obtain the MedDRA Preferred Term and Organ System ("body system"). The nature, incidence, severity and causality were AEs were summarized in a frequency table, by body system and treatment. The proportion of subjects experiencing one or more AEs were compared between groups, separately for each body system and for all AEs combined.	0.00% 0/27 • 28 days All treatment--emergent adverse events (AEs) are listed and MedDRA--coded to obtain the MedDRA Preferred Term and Organ System ("body system"). The nature, incidence, severity and causality were AEs were summarized in a frequency table, by body system and treatment. The proportion of subjects experiencing one or more AEs were compared between groups, separately for each body system and for all AEs combined.
Nervous system disorders head ache	7.7% 2/26 • Number of events 2 • 28 days All treatment--emergent adverse events (AEs) are listed and MedDRA--coded to obtain the MedDRA Preferred Term and Organ System ("body system"). The nature, incidence, severity and causality were AEs were summarized in a frequency table, by body system and treatment. The proportion of subjects experiencing one or more AEs were compared between groups, separately for each body system and for all AEs combined.	3.7% 1/27 • Number of events 1 • 28 days All treatment--emergent adverse events (AEs) are listed and MedDRA--coded to obtain the MedDRA Preferred Term and Organ System ("body system"). The nature, incidence, severity and causality were AEs were summarized in a frequency table, by body system and treatment. The proportion of subjects experiencing one or more AEs were compared between groups, separately for each body system and for all AEs combined.

Additional Information

Dr Barbara Leinweber, PhD

BDL Biochemistry, consultant for Mitosynergy

Phone: (520)334-5444

Email: barb@bdlbiochem.com

Results disclosure agreements

• Principal investigator is a sponsor employee The study PI (Dale Wilson) retired soon after the study was completed. KGK Synergize has undergone reorganization as KGK Science. The original intent was to publish the study results in a peer review journal.
• Publication restrictions are in place

Restriction type: OTHER