Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Neuromuscular Symptoms |
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. |
baseline and 28 days after enrollment |
|
Primary |
Platelet ATP |
Platelet ATP levels were measured as previously published in the literature. |
baseline and 28 days after enrollment |
|
Secondary |
Household Chores and Neuro Muscular Sumptoms |
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. |
baseline and 28 days after enrollment |
|
Secondary |
Cognition |
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. |
baseline and 28 days after enrollment |
|
Secondary |
Heart Rate |
heart rate is measured in beats per minute |
baseline and 28 days after enrollment |
|
Secondary |
Diastolic Blood Pressure |
The diastolic blood pressure was measured in mm Hg |
baseline and 28 days after enrollment |
|
Secondary |
Systolic Blood Pressure |
Systolic blood pressure was measured in mm Hg |
baseline and 28 days after enrollment. |
|
Secondary |
Hemoglobin |
changes measured in g/L blood |
baseline and 28 days after enrollment. |
|
Secondary |
Hematocrit |
changes in the fraction of whole blood occupied by red blood cells measured as L/L |
baseline and 28 days after enrollment |
|
Secondary |
WBC |
changes in white blood cells (WBC) measured in units of 10^9 per liter blood |
baseline and 28 days after enrollment |
|
Secondary |
RBC |
changes in red blood cells (RBC) measured in units of 10^12 per liter blood |
baseline and 28 days after enrollment |
|
Secondary |
MCV |
changes in mean corpuscular volume (MCV) measured in units of fL |
baseline and 28 days after enrollment |
|
Secondary |
MCH |
changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC |
baseline and 28 days after enrollment |
|
Secondary |
MCHC |
mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L |
baseline and 28 days after enrollment |
|
Secondary |
RDW |
changes in the RBC distribution width (RDW) are reported in units of percentage (%) |
baseline and 28 days after enrollment |
|
Secondary |
Platelets |
changes in the platelet counts are reported in units of 10^9 per liter blood |
baseline and 28 days after enrollment |
|
Secondary |
Neutrophils |
changes in neutrophils are reported in units of 10^9 per liter blood |
baseline and 28 days after enrollment |
|
Secondary |
Lymphocyte |
changes in lymphocytes are reported in units of 10^9 per liter blood |
baseline and 28 days after enrollment |
|
Secondary |
Monocyte |
changes in monocytes are reported in units of 10^9 per liter blood |
baseline and 28 days after enrollment |
|
Secondary |
Eosinophil |
changes in eosinophils are reported in units of 10^9 cells per liter blood |
baseline and 28 days after enrollment |
|
Secondary |
Basophil |
changes in basophils are reported in units of 10^9 cells per liter blood |
baseline and 28 days after enrollment |
|
Secondary |
NLR |
Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1 |
baseline and 28 days after enrollment |
|
Secondary |
Glucose |
changes in blood glucose are reported in units of mmol per liter |
baseline and 28 days after enrollment |
|
Secondary |
Urea |
changes in renal function as measured by blood urea are reported in units of mmol per liter |
baseline and 28 days after enrollment |
|
Secondary |
Creatinine |
changes in creatinine are reported in units of micromol per liter |
baseline and 28 days after enrollment |
|
Secondary |
eGFR |
changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m^2 |
baseline and 28 days after enrollment |
|
Secondary |
Sodium |
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 |
baseline and 28 days after enrollment |
|
Secondary |
Potassium |
changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com |
baseline and 28 days after enrollment |
|
Secondary |
Chloride |
changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com |
baseline and 28 days after enrollment |
|
Secondary |
Bilirubin |
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 |
baseline and 28 days after enrollment |
|
Secondary |
ALT |
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 |
baseline and 28 days after enrollment |
|
Secondary |
AST |
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 |
baseline and 28 days after enrollment |
|
Secondary |
GGT |
changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter |
baseline and 28 days after enrollment |
|
Secondary |
Copper |
changes in copper concentration in the blood are reported in units of micro moles per liter |
baseline and 28 days after enrollment |
|