Table 3.
Developmental, speech, and biochemical outcomes for children randomised to antioxidants versus no antioxidants or to folinic acid versus no folinic acid. Values are mean (SD) unless stated otherwise
| Outcomes | Antioxidants v no antioxidants | Folinic acid v no folinic acid | |||||
|---|---|---|---|---|---|---|---|
| Group A+B | Group C+D | Mean difference or ratio of means (95% CI) | Group A+C | Group B+D | Mean difference or ratio of means (95% CI) | ||
| Griffiths mental developmental scales* | |||||||
| Number | 73 | 65 | – | 68 | 70 | – | |
| Total GQ | 58.1 (9.5) | 56.9 (10.8) | 1.2 (−2.2 to 4.6) | 58.4 (10.5) | 56.7 (9.7) | 1.7 (−1.7 to 5.1) | |
| Griffiths subscales*: | |||||||
| Locomotor | 54.1 (12.0) | 51.1 (12.5) | 3.0 (−1.1 to 7.0) | 53.1 (11.6) | 52.3 (12.9) | 0.9 (−3.2 to 5.0) | |
| Personal-social | 62.6 (12.9) | 61.5 (13.2) | 1.1 (−3.2 to 5.4) | 62.7 (12.5) | 61.5 (13.5) | 1.2 (−3.2 to 5.6) | |
| Hearing and language | 56.5 (10.3) | 56.8 (14.3) | −0.3 (−4.5 to 3.9) | 56.9 (11.6) | 56.3 (12.9) | 0.6 (−3.6 to 4.9) | |
| Eye and hand | 61.9 (11.6) | 60.9 (12.3) | 1.0 (−3.0 to 5.1) | 62.6 (12.9) | 60.2 (10.7) | 2.3 (−1.8 to 6.4) | |
| Performance | 60.8 (15.7) | 59.3 (15.5) | 1.5 (−3.8 to 6.8) | 61.8 (16.5) | 58.5 (14.6) | 3.3 (−2.1 to 8.6) | |
| Receptive language† | |||||||
| Number | 73 | 65 | – | 69 | 69 | – | |
| Total gesture score | 31.3 (11.9) | 32.4 (11.4) | −1.1 (−5.1 to 2.9) | 32.0 (11.2) | 31.7 (12.1) | 0.3 (−3.8 to 4.4) | |
| Phrases understood | 15.7 (6.6) | 16.5 (7.4) | −0.8 (−3.2 to 1.6) | 16.3 (6.8) | 15.8 (7.2) | 0.5 (−2.0 to 2.9) | |
| Expressive language‡ | |||||||
| Number | 73 | 65 | – | 69 | 69 | – | |
| Mean No of words child says§ | 3.2 (3.6) | 4.9 (6.3) | 0.82 (0.60 to 1.12) | 4.7 (6.2) | 3.4 (3.7) | 1.05 (0.76 to 1.45) | |
| Mean No of words child signs§ | 6.0 (7.8) | 6.1 (7.6) | 0.93 (0.66 to 1.31) | 7.2 (8.5) | 4.9 (6.5) | 1.33 (0.93 to 1.89) | |
| Mean No of words child says or signs§ | 8.2 (8.3) | 9.7 (9.6) | 0.86 (0.61 to 1.21) | 10.4 (9.9) | 7.3 (7.7) | 1.24 (0.87 to 1.77) | |
| Blood analysis¶ | |||||||
| Number | 52 | 47 | – | 50 | 49 | – | |
| Superoxide dismutase (SOD-1) (U/mg Hb) | 4.0 (1.1) | 3.8 (1.1) | 0.2 (−0.2 to 0.6) | 3.9 (1.2) | 3.9 (0.9) | 0.1 (−0.4 to 0.5) | |
| Glutathione peroxidise (GSH-Px) (U/mg Hb)** | 66.3 (34.8) | 65.3 (37.7) | 4.2 (−9.3 to 17.7) | 71.7 (41.4) | 60.2 (29.4) | 7.6 (−6.0 to 21.3) | |
| Ratio of SOD-1 to GSH-Px§†† | 0.077 (0.06) | 0.077 (0.05) | 0.99 (0.79 to 1.24) | 0.077 (0.06) | 0.077 (0.04) | 1.01 (0.81 to 1.27) | |
| Urine analysis¶ | |||||||
| Number | 26 | 26 | – | 23 | 29 | – | |
| Isoprostanes§ (pmol/mmol creatinine) | 2264 (2202) | 2306 (2399) | 1.10 (0.61 to 2.00) | 2243 (2143) | 2318 (2419) | 0.92 (0.52 to 1.61) | |
GQ=general quotient; group A=antioxidants and folinic acid; group B=antioxidants only; group C=folinic acid only; group D=placebo; Hb=haemoglobin.
*Mean (SD) and confidence interval adjusted for area of residence, sex, and congenital heart disease.
†Mean (SD) and confidence interval adjusted for area of residence, age, sex, and congenital heart disease.
‡Unadjusted mean (SD); confidence interval adjusted for area of residence, age, sex, and congenital heart disease.
§Mean difference calculated on log scale and back transformed to give ratio of means on original scale.
¶Unadjusted mean (SD); confidence interval adjusted for area of residence, sex, and congenital heart disease.
**After exclusion of outlier with GSH-Px of 312.
††After exclusion of outlier with SOD:GSH-Px ratio of 6.4.