TABLE 3.
Baseline demographic characteristics of the ITT sample1
| Variable | Choline (n = 29) | Placebo (n = 26) | P2 |
| Sex, n (%) | 0.50 | ||
| M | 13 (44.8) | 14 (53.8) | |
| F | 16 (55.2) | 12 (46.2) | |
| Age, y | 8.3 ± 1.603 | 8.2 ± 1.94 | 0.87 |
| Age strata, n (%) | 0.69 | ||
| 5–6 y | 6 (20.7) | 8 (30.8) | |
| 7–8 y | 11 (37.9) | 9 (34.6) | |
| 9–10 y | 12 (41.4) | 9 (34.6) | |
| Body weight, kg | 59.8 ± 15.91 | 63.9 ± 25.43 | 0.47 |
| Percentile | 44.7 ± 32.94 | 49.8 ± 35.00 | 0.58 |
| Race, n (%) | 0.78 | ||
| Caucasian | 20 (69.0) | 17 (65.4) | |
| African American | 5 (17.2) | 5 (19.2) | |
| Multiracial | 4 (13.8) | 4 (15.4) | |
| Ethnicity, n (%) | 0.29 | ||
| Hispanic | 2 (6.9) | 3 (11.5) | |
| Not Hispanic | 25 (86.2) | 18 (69.2) | |
| Not reported | 2 (6.9) | 5 (19.2) | |
| SES | 48.5 ± 12.99 | 46.4 ± 13.65 | 0.55 |
| Handedness, n (%) | 0.17 | ||
| Right | 24 (82.8) | 24 (92.3) | |
| Left | 5 (17.2) | 1 (3.8) | |
| Mixed | 0 (0.0) | 1 (3.8) | |
| FAS diagnosis,4 n (%) | 0.96 | ||
| FAS | 3 (10.3) | 3 (11.5) | |
| Prenatally exposed, non-FAS | 16 (55.2) | 15 (57.7) | |
| Not diagnosed | 10 (34.5) | 8 (30.8) | |
| Home placement, n (%) | 0.17 | ||
| Biological | 2 (6.9) | 5 (19.2) | |
| Adopted | 27 (93.1) | 21 (80.8) | |
| Psychiatric comorbidity, n (%) | 0.41 | ||
| None | 12 (41.4) | 8 (30.8) | |
| ≥1 diagnosis | 17 (58.6) | 18 (69.2) | |
| Medications, n (%) | |||
| Noncognitive | 5 (17.2) | 6 (23.1) | 0.63 |
| Cognitive | 19 (65.5) | 17 (65.4) | 0.85 |
| Site, n (%) | 0.58 | ||
| San Diego | 11 (37.9) | 8 (30.8) | |
| Ohio | 18 (62.1) | 18 (69.2) |
1
FAS, fetal alcohol syndrome; ITT, intention-to-treat; SES, socioeconomic status.
2
Comparisons between treatment groups were conducted with the use of independent samples t tests for continuous variables and a chi-square test for categorical variables.
3
Mean ± SD (all such values).
4
FAS children met 3 diagnostic criteria for FAS on the basis of a dysmorphologic examination. Prenatally exposed non-FAS children did not meet the criteria for full FAS on the basis of a dysmorphologic examination but received a diagnosis on the spectrum. Not diagnosed children were not evaluated for a diagnosis.