Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Number of Occurrences of Painful Sickle Cell Crises |
The mean number of painful sickle crisis through week 48 |
From Week 0 through Week 48 (cumulative) |
|
Secondary |
Frequency of Hospitalizations for Sickle Cell Pain |
The mean number of hospitalizations through week 48 |
From Week 0 through Week 48 (cumulative) |
|
Secondary |
Frequency of Emergency Room Visits for Sickle Cell Pain |
The mean number of emergency room visits through week 48 |
From Week 0 through Week 48 (cumulative) |
|
Secondary |
The Effect of Oral L-glutamine on Hematological Parameters - Hemoglobin |
Patient's hemoglobin will be collected at each visit.Change from Baseline will be reported at Weeks 4, 24 and 40. |
Baseline, Weeks 4, 24 and 40 |
|
Secondary |
The Effect of Oral L-glutamine on Hematological Parameters - Hematocrit |
Patient's hematocrit will be collected at each visit. Change from Baseline will be reported at Weeks 4, 24 and 40 |
Baseline, Weeks 4, 24, and 40 |
|
Secondary |
The Effect of Oral L-glutamine on Hematological Parameters - Reticulocyte Count |
Patient's reticulocyte count will be collected at each visit. Change from Baseline will be reported at Weeks 4, 24 and 40 |
Baseline, Weeks 0, 4, 24, 40 |
|
Secondary |
Number of Participants With Narcotic Usage |
Analysis of narcotic usage was performed for the subset of patients with any narcotic use who completed the study. Changes in narcotic usage were determined by an independent consultant prior to database lock using morphine equivalents to determine relative use. |
Week 24, Week 48 |
|
Secondary |
Energy Level (11-point Scale) |
The patient's energy level was evaluated at each visit using an 11 point scale from 0=extremely tired to 10=extremely energetic |
Collected at Week 0, 8, 16, 24, 32, 40, 48 |
|
Secondary |
Patient Appetite (3-point Scale) |
Patient's appetite level was evaluated at each visit using a 3 point scale: above average, average and below average. The parentages of patient at each visit whose appetite level was below, normal or above average were compared using CMH test (row mean scores) controlling for study center. |
Collected at Week 0, 8, 16, 24, 32, 40, 48 |
|
Secondary |
The Effect of Oral L-glutamine on Vital Signs - Blood Pressure |
Patient's blood pressure will be collected at each visit. Change from Baseline will be reported at Weeks 4, 24, and 48 |
Baseline, Weeks 4, 24, and 48 |
|
Secondary |
The Effect of Oral L-glutamine on Vital Signs - Temperature |
Patient's temperature will be collected at each visit. Change from Baseline will be reported at Weeks 4, 24, and 48 |
Baseline, Weeks 4, 24, and 48 |
|
Secondary |
The Effect of Oral L-glutamine on Vital Signs - Respiration |
Respiration will be collected at each visit. Change from Baseline will be reported at Weeks 4, 24, and 48 |
Baseline, Weeks 4, 24, and 48 |
|
Secondary |
The Effect of Oral L-glutamine on Vital Signs - Pulse Rate |
Patient's pulse rate will be collected at each visit, Change from Baseline will be reported at Weeks 4, 24, and 48 |
Baseline, Weeks 4, 24, and 48 |
|
Secondary |
Effect of L-glutamine on Alcohol Use |
The patient's alcohol usage will be assessed at each visit. Alcohol usage will be reported at Weeks 0, 8,16, 24, 32, 40 and 48 |
Weeks 0, 8,16, 24, 32, 40 and 48 |
|
Secondary |
Effect of L-glutamine on Tobacco Use |
Patient's alcohol usage will be assessed at each visit. Alcohol usage will be reported at Weeks 0, 8,16, 24, 32, 40 and 48 |
Weeks 0, 8,16, 24, 32, 40 and 48 |
|
Secondary |
The Effect of Oral L-glutamine on the Number of Days Patient's Daily Activities Are Interrupted Due to Sickle Cell Pain |
Percentage of days a patient's daily activities were interrupted due to sickle pain calculated at each visit. Day's interrupted will be reported at Weeks 0, 8,16, 24, 32, 40 and 48 |
Weeks 0, 8,16, 24, 32, 40 and 48 |
|
Secondary |
The Effect of Oral L-glutamine on Subjective Quality of Life |
The subjective quality of life was evaluated using the scoring of the RAND 36-Item Health Survey Questionnaire. The subjective quality of life (Physical functioning, Physical health, Emotional problems, Energy/Fatigue, Emotional well being, Social functioning, Pain, General health) will be reported at Baseline and Week 24 (or at time of discontinuation). The range for Physical functioning, Physical health, Emotional problems, Emotional well being and Social functioning is 0-100, with a high score denotes a better quality of life. For Energy/Fatigue, Pain and General health the range is 0-100, with a lower score denotes better quality of life. |
Baseline and Week 24 (or at time of discontinuation) |
|
Secondary |
Effect of Oral L--glutamine on Height |
Height will be measured at each visit. Change from Baseline will be reported at Weeks 4, 24, and 48 |
Baseline, Weeks 4, 24, and 48 |
|
Secondary |
Effect of Oral L--glutamine on Weight |
Weight will be measured at each visit. Change from Baseline will be reported at Weeks 4, 24, and 48 |
Baseline, Weeks 4, 24 and 48 |
|
Secondary |
Effect of L-glutamine on Subjective Exercise Tolerance - Minutes Patient Could Walk Without Rest |
Minutes patient could walk without rest will be measured at each visit. Change from Baseline will be reported at Weeks 4, 24, and 48. |
Baseline, Weeks 4, 24, and 48. |
|
Secondary |
Effect of L-glutamine on Subjective Exercise Tolerance - Minutes Patient Could Run Without Rest |
Minutes patient could run without rest will be measured at each visit. Change from Baseline will be reported at Weeks 4, 24, and 48. |
Baseline, Weeks 4, 24, and 48. |
|
Secondary |
Effect of L-glutamine on Subjective Exercise Tolerance - Distance Patient Could Walk Without Rest |
Distance patient could walk without rest will be collected at each visit. Change from Baseline will be reported at Weeks 4, 24, and 48. |
Baseline, Weeks 4, 24, and 48. |
|
Secondary |
Effect of L-glutamine on Subjective Exercise Tolerance - Distance Patient Could Run Without Rest |
Distance patient could run without rest will be collected at each visit. Change from Baseline will be reported at Weeks 4, 24, and 48. |
Baseline, Weeks 4, 24, and 48. |
|