Table 4:
Treatment-Emergent Adverse Eventsa Based on the Pediatric Adverse Events Rating Scale
| Adverse event question | Micronutrient N (%) |
Placebo N (%) |
Total N (%) |
|---|---|---|---|
| Irritability | 1 (1.6) | 1 (3.0) | 2 (2.1) |
| Angry or hostile | 3 (4.7) | 1 (3.0) | 4 (4.1) |
| Sad or low mood | 2 (3.1) | 0 (0.0) | 2 (2.1) |
| Lack of interest | 2 (3.1) | 0 (0.0) | 2 (2.1) |
| Mood swings | 2 (3.1) | 1 (3.0) | 3 (3.1) |
| Anxious, tense or uptight | 3 (4.7) | 1 (3.0) | 4 (4.1) |
| Lack of self-control/impulsive | 3 (4.7) | 2 (6.1) | 5 (5.2) |
| Trouble paying attention or concentrating | 2 (3.1) | 0 (0.0) | 2 (2.1) |
| Racing thoughts | 1 (1.6) | 1 (3.0) | 2 (2.1) |
| Can't sit or stand still | 3 (4.7) | 1 (3.0) | 4 (4.1) |
| Tired/fatigued | 2 (3.1) | 1 (3.0) | 3 (3.1) |
| Trouble falling asleep | 4 (6.3) | 1 (3.0) | 5 (5.2) |
| Tried to hurt him/herself | 1 (1.6) | 0 (0.0) | 1 (1.0) |
| Hurt someone or something | 1 (1.6) | 1 (3.0) | 2 (2.1) |
| Less hungry | 4 (6.3) | 1 (3.0) | 5 (5.2) |
| Lost weight | 0 (0.0) | 1 (3.0) | 1 (1.0) |
| Dry mouth | 1 (1.6) | 0 (0.0) | 1 (1.0) |
| Gained weight | 0 (0.0) | 1 (3.0) | 1 (1.0) |
| Muscle shaking, stiffness or cramps | 0 (0.0) | 1 (3.0) | 1 (1.0) |
| Tics | 0 (0.0) | 1 (3.0) | 1 (1.0) |
| Unusually good mood or super happy | 1 (1.6) | 1 (3.0) | 2 (2.1) |
| Skin rash or irritation | 1 (1.6) | 0 (0.0) | 1 (1.0) |
| Heart racing or skipping beats | 0 (0.0) | 1 (3.0) | 1 (1.0) |
| GI Symptomsb | 17 (26.6)c | 8 (24.2)c | 25 (25.8) |
| Stomach ache or cramps | 7 (10.9) | 6 (18.2) | 13 (13.4) |
| Nausea/sick to stomach | 3 (4.7) | 1 (3.0) | 4 (4.1) |
| Throwing up/vomiting | 4 (6.3) | 0 (0.0) | 4 (4.1) |
| Diarrhea | 7 (10.9) | 1 (3.0) | 8 (8.2) |
| Headache | 1 (1.6) | 2 (6.1) | 3 (3.1) |
| Other | 5 (7.8) | 5 (15.2) | 10 (10.3) |
Note:
AEs rated as “possibly,” “probably,” or “likely” attributable to the intervention. Number and percentages refer to participants having the AE, not number of AEs
GI = Gastrointestinal; symptoms are a combination of discrete participants experiencing stomach ache or cramps, nausea/sick to stomach, throwing up/vomiting, and diarrhea
p = 0.80