每日补充 400 或 800µg/天叶酸以达到非孕妇保护性红细胞叶酸浓度的效果：一项随机试验。
The effectiveness of daily supplementation with 400 or 800 µg/day folate in reaching protective red blood folate concentrations in non-pregnant women: a randomized trial.
机构信息
Aarhus Institute of Advanced Studies, University of Aarhus, Høegh-Guldbergs Gade 6B, Building 1632, 8000, Aarhus C, Denmark.
BioTeSys GmbH, Schelztorstr. 54-56, 73728, Esslingen, Germany.
出版信息
Eur J Nutr. 2018 Aug;57(5):1771-1780. doi: 10.1007/s00394-017-1461-8. Epub 2017 Apr 26.
PURPOSE
Folate required to achieve desirable red blood cell (RBC) folate concentrations within 4-8 weeks pre-pregnancy is not known. We studied the effect of supplementation with 400 or 800 µg/day folate in achieving RBC-folate ≥906 nmol/L.
METHODS
Non-pregnant women were randomized to receive multinutrient supplements containing 400 µg/day (n = 100) or 800 µg/day (n = 101) folate [folic acid and (6S)-5-CH-Hfolate-Ca (1:1)]. The changes of folate biomarkers were studied after 4 and 8 weeks in the 198 women who returned at least for visit 2.
RESULTS
At baseline, 12 of the 198 participants (6.1%) had RBC-folate <340 nmol/L, but 88% had levels <906 nmol/L. The RBC-folate concentrations increased significantly in the 800 µg/day (mean ± SD = 652 ± 295 at baseline; 928 ± 330 at 4 weeks; and 1218 ± 435 nmol/L at 8 weeks) compared with the 400 µg/day [632 ± 285 at baseline (p = 0.578); 805 ± 363 at 4 weeks (p < 0.001); 1021 ± 414 nmol/L at 8 weeks (p < 0.001)]. The changes of RBC-folate were greater in the 800 µg/day than in the 400 µg/day at any time (changes after 8 weeks: 566 ± 260 vs. 389 ± 229 nmol/L; p < 0.001). Significantly more women in the 800 µg group achieved desirable RBC-folate concentrations at 4 weeks (45.5 vs. 31.3%; p = 0.041) or 8 weeks (83.8 vs. 54.5%; p < 0.001) compared with the 400 µg group. RBC-folate levels below the population median (590 nmol/L) were associated with a reduced response to supplements.
CONCLUSIONS
88% of the women had insufficient RBC-folate to prevent birth defects, while 6.1% had deficiency. Women with low RBC-folate were unlikely to achieve desirable levels within 4-8 weeks, unless they receive 800 µg/day. The current supplementation recommendations are not sufficient in countries not applying fortification.
TRIALS REGISTER
The trial was registered at The German Clinical Trials Register: DRKS-ID: DRKS00009770.
目的
目前尚不清楚孕妇在怀孕前 4-8 周内需要多少叶酸才能达到理想的红细胞（RBC）叶酸浓度。本研究旨在探讨补充 400μg/天或 800μg/天叶酸对达到 RBC-叶酸≥906nmol/L 的影响。
方法
将未怀孕的妇女随机分为两组，分别接受含有 400μg/天（n=100）或 800μg/天（n=101）叶酸[叶酸和（6S）-5-CH-Hfolate-Ca（1:1）]的多种营养素补充剂。在返回至少第二次就诊的 198 名女性中，研究了在 4 周和 8 周后叶酸生物标志物的变化。
结果
在基线时，198 名参与者中有 12 名（6.1%）的 RBC-叶酸<340nmol/L，但 88%的 RBC-叶酸<906nmol/L。与 400μg/天组相比，800μg/天组的 RBC-叶酸浓度在 4 周（平均±SD=652±295 基线；928±330 周；1218±435nmol/L）和 8 周（928±330 基线；1218±435nmol/L）显著增加（p<0.001）。与 400μg/天组相比，800μg/天组在任何时间的 RBC-叶酸变化均更大（8 周后的变化：566±260 vs. 389±229nmol/L；p<0.001）。在 4 周（45.5% vs. 31.3%；p=0.041）或 8 周（83.8% vs. 54.5%；p<0.001）时，800μg/天组中达到理想 RBC-叶酸浓度的女性比例显著高于 400μg/天组。RBC-叶酸水平低于人群中位数（590nmol/L）与补充剂反应降低相关。
结论
88%的女性 RBC-叶酸不足，无法预防出生缺陷，而 6.1%的女性则存在缺乏。RBC-叶酸水平较低的女性不太可能在 4-8 周内达到理想水平，除非她们每天补充 800μg。在未实施强化的国家，目前的补充建议是不够的。
试验注册
该试验在德国临床试验注册中心注册：DRKS-ID：DRKS00009770。
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