Table 1.
Demographic and Clinical Characteristics of the Participants (Mean ± Standard Deviation, Unless Noted Otherwise)
| Placebo, n = 24 | Ca+VitD, n = 23 | p | |
|---|---|---|---|
| Age, years | 12.1 ± 3.0 | 10.8 ± 3.0 | >0.10 |
| Tanner stage (%) | |||
| I/II/III/IV/V | 48/13/0/22/17 | 43/22/9/13/13 | >0.60 |
| Race/ethnicity, n (%) | >0.10 | ||
| White | 19 (79) | 19 (86) | |
| African American | 5 (21) | 1 (5) | |
| Hispanic | 0 | 2 (9) | |
| BMI Z-score | 0.25 ± 1.05 | 0.89 ± 0.81 | <0.04 |
| Physical activity | 2.5 ± 1.1 | 2.6 ± 1.4 | >0.60 |
| Daily calcium intake, mg | |||
| At study entry | 888 ± 326 | 1071 ± 367 | <0.06 |
| At study completion | 970 ± 409 | 1000 ± 496 | >0.20 |
| Daily vitamin D intake, IU | |||
| At study entry | 196 ± 85 | 237 ± 106 | <0.03 |
| At study completion | 205 ± 107 | 204 ± 87 | >0.80 |
| Vitamin D concentration, ng/mL | |||
| At study entry | 31.2 ± 11.6 | 31.9 ± 11.9 | >0.80 |
| At study completion | 31.2 ± 35.5 | 35.5 ± 18.0 | >0.70 |
| Vitamin D status, n (%) | >0.80 | ||
| Normal, ≥30 ng/mL | 13 (54) | 13 (57) | |
| Borderline, 20–30 ng/mL | 7 (29) | 5 (22) | |
| Deficient, <20 ng/mL | 4 (17) | 5 (22) | |
| Prolactin, ng/mL | |||
| At study entry | 30.1 ± 9.0 | 33.0 ± 15.4 | >0.80 |
| At study completion | 30.3 ± 16.3 | 30.0 ± 19.1 | >0.90 |
| Psychiatric characteristics, n (%) | |||
| ADHD | 23 (96) | 22 (96) | 1.00 |
| Disruptive behavior disorder | 23 (96) | 22 (96) | 1.00 |
| Anxiety disorder | 10 (42) | 14 (61) | >0.10 |
| Autism spectrum disorder | 4 (17) | 6 (26) | >0.40 |
| Tic disorder | 0 | 4 (17) | <0.05 |
| Psychostimulant use | 19 (79) | 17 (74) | >0.60 |
| SSRIs | 9 (38) | 12 (52) | >0.30 |
| Daily risperidone dose, mg | |||
| At study entry | 2.1 ± 1.0 | 2.1 ± 1.3 | >0.70 |
| At study completion | 2.3 ± 1.4 | 2.5 ± 1.6 | >0.70 |
| Risperidone treatment duration, years | 3.8 ± 2.1 | 2.7 ± 2.0 | <0.05 |
Significant results (p < 0.05) are bolded and marginally significant results (p < 0.10) are bolded and italicized.
ADHD, attention-deficit/hyperactivity disorder; BMI, body mass index; Ca+VitD, calcium and vitamin D3; SSRIs, selective serotonin reuptake inhibitors.