Ellis Jill M, Tan Hooi Kuan, Gilbert Ruth E, Muller David P R, Henley William, Moy Robert, Pumphrey Rachel, Ani Cornelius, Davies Sarah, Edwards Vanessa, Green Heather, Salt Alison, Logan Stuart
Centre for Evidence-based Child Health, Centre for Paediatric Epidemiology and Biostatistics, UCL Institute of Child Health, London WC1N 1EH.
BMJ. 2008 Mar 15;336(7644):594-7. doi: 10.1136/bmj.39465.544028.AE. Epub 2008 Feb 21.
To assess whether supplementation with antioxidants, folinic acid, or both improves the psychomotor and language development of children with Down's syndrome.
Randomised controlled trial with two by two factorial design.
Children living in the Midlands, Greater London, and the south west of England.
156 infants aged under 7 months with trisomy 21.
Daily oral supplementation with antioxidants (selenium 10 mug, zinc 5 mg, vitamin A 0.9 mg, vitamin E 100 mg, and vitamin C 50 mg), folinic acid (0.1 mg), antioxidants and folinic acid combined, or placebo.
Griffiths developmental quotient and an adapted MacArthur communicative development inventory 18 months after starting supplementation; biochemical markers in blood and urine at age 12 months.
Children randomised to antioxidant supplements attained similar developmental outcomes to those without antioxidants (mean Griffiths developmental quotient 57.3 v 56.1; adjusted mean difference 1.2 points, 95% confidence interval -2.2 to 4.6). Comparison of children randomised to folinic acid supplements or no folinic acid also showed no significant differences in Griffiths developmental quotient (mean 57.6 v 55.9; adjusted mean difference 1.7, -1.7 to 5.1). No between group differences were seen in the mean numbers of words said or signed: for antioxidants versus none the ratio of means was 0.85 (95% confidence interval 0.6 to 1.2), and for folinic acid versus none it was 1.24 (0.87 to 1.77). No significant differences were found between any of the groups in the biochemical outcomes measured. Adjustment for potential confounders did not appreciably change the results.
This study provides no evidence to support the use of antioxidant or folinic acid supplements in children with Down's syndrome.
Clinical trials NCT00378456.
评估补充抗氧化剂、亚叶酸，或两者同时补充是否能改善唐氏综合征患儿的精神运动和语言发育。
采用二乘二析因设计的随机对照试验。
居住在英格兰中部地区、大伦敦地区和西南部的儿童。
156名7个月以下的21三体综合征婴儿。
每日口服抗氧化剂（硒10微克、锌5毫克、维生素A 0.9毫克、维生素E 100毫克和维生素C 50毫克）、亚叶酸（0.1毫克）、抗氧化剂与亚叶酸联合使用，或安慰剂。
开始补充18个月后的格里菲斯发育商和改编的麦克阿瑟沟通发展量表；12个月时血液和尿液中的生化指标。
随机分配到抗氧化剂补充组的儿童与未补充抗氧化剂的儿童发育结果相似（平均格里菲斯发育商57.3对56.1；调整后平均差异1.2分，95%置信区间-2.2至4.6）。随机分配到亚叶酸补充组或未补充亚叶酸组的儿童在格里菲斯发育商方面也无显著差异（平均57.6对55.9；调整后平均差异1.7，-1.7至5.1）。在说出或比划的单词平均数方面，各治疗组间无差异：抗氧化剂组与未补充组的均值比为0.85（95%置信区间0.6至1.2），亚叶酸组与未补充组的均值比为1.24（0.87至1.77）。在测量的生化指标方面，各治疗组间均无显著差异。对潜在混杂因素进行校正后，结果无明显变化。
本研究没有证据支持在唐氏综合征患儿中使用抗氧化剂或亚叶酸补充剂。
临床试验NCT00378456。
