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在每周补充铁-叶酸制剂中添加叶酸对非孕期女性减少贫血并无额外益处:马来西亚的一项随机对照试验

The Inclusion of Folic Acid in Weekly Iron-Folic Acid Supplements Confers no Additional Benefit on Anemia Reduction in Nonpregnant Women: A Randomized Controlled Trial in Malaysia.

作者信息

Samson Kaitlyn L I, Loh Su Peng, Lee Siew Siew, Sulistyoningrum Dian C, Khor Geok Lin, Mohd Shariff Zalilah Binti, Ismai Irmi Zarina, Makrides Maria, Hutcheon Jennifer A, Roche Marion L, Green Timothy J, Karakochuk Crystal D

机构信息

Food, Nutrition, and Health, University of British Columbia, Vancouver, British Columbia, Canada.

BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.

出版信息

J Nutr. 2021 Aug 7;151(8):2264-2270. doi: 10.1093/jn/nxab115.

DOI:10.1093/jn/nxab115
PMID:33978167
Abstract

BACKGROUND

Weekly iron-folic acid (IFA) supplements are recommended for all menstruating women in countries where anemia prevalence is ≥20%; however, it is unknown whether the inclusion of folic acid in weekly IFA supplements reduces anemia.

OBJECTIVES

We examined whether the inclusion of folic acid in weekly IFA supplements conferred any benefit on hemoglobin (Hb) concentration, anemia reduction, or iron status [ferritin and soluble transferrin receptor (sTfR)], over iron alone.

METHODS

In this secondary analysis of a randomized controlled trial in Malaysia, n = 311 nonpregnant women (18-45 y old) received 60 mg Fe with either 0, 0.4, or 2.8 mg folic acid once-weekly for 16 wk. Fasting blood was collected at baseline and 16 wk. A generalized linear model (normal distribution with identity link) was used to assess Hb concentration at 16 wk (primary outcome).

RESULTS

At baseline, 84% of women had low folate status (plasma folate < 14 nmol/L). At 16 wk, marginal mean (95% CI) Hb was 131 (130, 133), 131 (129, 132), and 132 (130, 133) g/L; ferritin was 58.2 (53.9, 62.5), 56.5 (52.2, 60.9), and 58.0 (53.7, 62.3) μg/L; and sTfR was 5.8 (5.5, 6.1), 5.8 (5.5, 6.1), and 5.9 (5.6, 6.2) mg/L in the 0, 0.4, and 2.8 mg/wk groups, respectively, with no differences between groups (P > 0.05). Baseline plasma folate concentration did not modify the effect of treatment on Hb concentration at 16 wk. Among all women, the risks of anemia [risk ratio (RR): 0.65; 95% CI: 0.45, 0.96; P = 0.03] and iron deficiency based on ferritin (RR: 0.30; 95% CI: 0.20, 0.44; P < 0.001) were lower at 16 wk than at baseline.

CONCLUSIONS

Despite the low folate status among these nonpregnant Malaysian women, the inclusion of folic acid in weekly IFA supplements did not reduce anemia or improve iron status, over iron alone. However, the benefits of folic acid for neural tube defect prevention still warrant its retention in weekly IFA supplements.This trial was registered at www.anzctr.org.au as ACTRN12619000818134.

摘要

背景

在贫血患病率≥20%的国家,建议所有经期女性每周补充铁叶酸(IFA);然而,尚不清楚每周补充的IFA中加入叶酸是否能降低贫血率。

目的

我们研究了与仅补充铁相比,每周补充的IFA中加入叶酸是否能对血红蛋白(Hb)浓度、贫血率降低或铁状态[铁蛋白和可溶性转铁蛋白受体(sTfR)]产生任何益处。

方法

在马来西亚一项随机对照试验的二次分析中,n = 311名非妊娠女性(18 - 45岁)每周接受一次60 mg铁,分别添加0、0.4或2.8 mg叶酸,持续16周。在基线和16周时采集空腹血样。采用广义线性模型(具有恒等连接的正态分布)评估16周时的Hb浓度(主要结局)。

结果

在基线时,84%的女性叶酸水平较低(血浆叶酸<14 nmol/L)。在16周时,0、0.4和2.8 mg/周组的边际均值(95%CI)Hb分别为131(130, 133)、131(129, 132)和132(130, 133)g/L;铁蛋白分别为58.2(53.9, 62.5)、56.5(52.2, 60.9)和58.0(53.7, 62.3)μg/L;sTfR分别为5.8(5.5, 6.1)、5.8(5.5, 6.1)和5.9(5.6, 6.2)mg/L,组间无差异(P>0.05)。基线血浆叶酸浓度未改变治疗对16周时Hb浓度的影响。在所有女性中,16周时贫血风险[风险比(RR):0.65;95%CI:0.45, 0.96;P = 0.03]和基于铁蛋白的缺铁风险(RR:0.30;95%CI:0.20, 0.44;P<0.001)低于基线水平。

结论

尽管这些马来西亚非妊娠女性叶酸水平较低,但与仅补充铁相比,每周补充的IFA中加入叶酸并未降低贫血率或改善铁状态。然而,叶酸对预防神经管缺陷的益处仍使其有必要保留在每周补充的IFA中。本试验在www.anzctr.org.au注册,注册号为ACTRN12619000818134。

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