327 Maternal B-12 supplementation in vegetarian pregnant women improves maternal B-12 status and infant neurodevelopment: The MATCOBIND multi-centric double-blind randomised-control-trial
327 Maternal B-12 supplementation in vegetarian pregnant women improves maternal B-12 status and infant neurodevelopment: The MATCOBIND multi-centric double-blind randomised-control-trial
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327 素食孕妇补充 B-12 可改善母亲 B-12 状态和婴儿神经发育：MATCOBIND 多中心双盲随机对照试验
DOI：
10.1136/archdischild-2023-rcpch.486
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Nagpal J
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文献类型：
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作者：
Nagpal J
目的维生素B-12缺乏症在许多低收入和中低收入国家很常见。素食主义者的饮食习惯往往有助于这种高患病率。几项观察性研究已经证明了妊娠期B-1,2缺乏与婴儿神经发育不良的相关性[1，2]。然而，临床试验很少且不确定[3，4]。因此，目前的临床试验建议评估母亲补充B-12对素食孕妇改善9个月龄婴儿神经发育的功效。第三个三月末母亲和9个月龄婴儿的生化B-12状态。一项随机对照试验在印度新德里（n=370）和尼泊尔加德满都（n=338）的三级保健机构招募了708名妊娠早期的素食妇女。母亲们被随机分配接受口服甲钴胺补充剂（250 mcg（A组）或50 mcg（B组;准对照）），从入组到产后6个月作为每日胶囊。在妊娠、分娩和婴儿期对母亲和婴儿进行机构访视时记录人体测量、间隔/当前发病率、医疗建议（药物/补充剂）和饮食摄入量。使用印度婴儿发育评估量表[5]评估9个月时的婴儿神经发育，并使用布拉德利HOME量表[6]评估家庭环境。在登记和第三个三个月之间的母亲B-12状态的变化，和婴儿B-12状态在9个月的年龄进行了估计。两组的基线特征相似（A组n=255; B组n=276; p>0.05）。表1总结了结果。如上所述，A组（平均值，标准差）中孕早期和孕晚期之间母体B-12水平的平均增加值：104.9[159.1] pg/ml高于B组47.5[118.0] pg/ml; p<0.01。Holo-TC水平也有类似的改善（p<0.01），而血清铁蛋白、维生素D和叶酸的变化在两组之间也相似（p>0.05），与预期一致。两组新生儿体格测量、发病率和APGAR评分相似（p>0.05）。两组之间的牛奶喂养、补充喂养、间隔发病率、生长和HOME评分也具有可比性（p>0.05）。A组的智力发育商（DQ）：103.7[7.7]高于B组：101.7[8.8]; p<0.01），对应于7.8百分位数的平均差异（p<0.01）。平均运动DQ，婴儿B-12状态和新生儿和婴儿的人体测量两组之间是相似的（p>0.05）。结论母亲B-12状态的改善和精神DQ在9个月是统计学上显着更好与250微克/天的B-12补充素食孕妇相比，50微克/天。维生素B12缺乏对婴儿神经发育的影响：目前的知识和可能的机制第66卷，营养评论。2008：250-5.Sklar R.纯素饮食母亲母乳喂养的婴儿营养维生素B12缺乏症。临床儿科（Phila）1986;25（4）：219- 21。Srinivasan K，托马斯T，Kapanee ARM，Ramthal A，Bellinger DC，Bosch RJ，et al.产妇维生素B12补充剂对早期婴儿神经认知结果的影响：一项随机对照临床试验。Matern Child Nutr.2016;doi：10.1111/mcn.12325.Siddiqua TJ，Ahmad SM，Ahsan KB，Rashid M，Roy A，Rahman SM，et al. Vitamin B12 supplementation during pregnancy and postpartum improves B12 status of both mothers and infants but vaccine response in mothers.
ObjectivesVitamin B-12 deficiency is common in many low- and low-middle-income countries. Vegetarian dietary practices often contribute to this high prevalence. Several observational studies have documented the association of B-12 deficiency in pregnancy with poor neurodevelopment amongst infants [1,2]. However, clinical trials are few and inconclusive [3,4]. Hence, the current clinical trial proposed to evaluate the efficacy of maternal B-12 supplementation in vegetarian pregnant women for improving-Infant neurodevelopment at 9 months of ageBiochemical B-12 status in mothers at the end of 3rd trimester and in infants at 9 monthsMethodsThis multi-center, double-blind, randomized controlled trial enrolled 708 vegetarian women in their first trimester from tertiary care facilities in New Delhi, India (n=370) and Kathmandu, Nepal (n=338). Mothers were randomized to receive oral methyl-cobalamin supplementation (250 mcg (Group-A) or 50 mcg (Group-B; quasi-control)) from enrollment to 6-months postpartum as daily capsules. Anthropometry, interval/current morbidity, medical advice (medicines/supplements), and dietary intake were recorded at the facility visits of the mother and infant through pregnancy, childbirth, and infancy. Infant neurodevelopment at 9 months was assessed using the Development Assessment Scale of Indian Infants[5] and the home environment was evaluated using the Bradley HOME inventory[6]. Change in maternal B-12 status between enrollment and the 3rd trimester, and infant B-12 status at 9 months of age were estimated.Results531 subjects completed the study (177 lost to follow-up; comparable for baseline characteristics). The two groups were similar for baseline characteristics (Group-A n=255; Group-B n=276; p>0.05). Table 1 summarizes the outcomes. As presented mean increase in maternal B-12 levels between 1st and 3rd trimester was greater in Group-A (mean, SD): 104.9[159.1] than Group-B 47.5[118.0] pg/ml; p<0.01. Similar improvements were noted in Holo-TC levels (p<0.01) while the changes in Serum Ferritin, Vitamin-D and Folate were similar between the two groups (p>0.05) as expected. Newborn anthropometry, morbidity profiles and APGAR Scores were similar between the two groups (p>0.05). Milk feeding, complementary feeding, interval morbidity, growth and HOME scores were also comparable between the two groups (p>0.05). Mental Developmental Quotient(DQ) was higher in Group-A: 103.7[7.7] vs. Group-B: 101.7[8.8]; p<0.01) corresponding to a mean difference of 7.8 centiles (p<0.01). Mean Motor DQ, infant B-12 status and newborn and infant anthropometry were similar between the two groups (p>0.05).ConclusionMaternal B-12 status improvement and Mental DQ at 9 months are statistically significantly better with 250 mcg/d B-12 supplementation of vegetarian pregnant women compared with 50 mcg/d.ReferencesDror DK, Allen LH. Effect of vitamin B12 deficiency on neurodevelopment in infants: Current knowledge and possible mechanisms Vol. 66,Nutrition Reviews. 2008:250–5.Sklar R. Nutritional vitamin B12 deficiency in a breast-fed infant of a vegan-diet mother.Clin Pediatr (Phila)1986;25(4):219–21.Srinivasan K, Thomas T, Kapanee ARM, Ramthal A, Bellinger DC, Bosch RJ,et al. Effects of maternal vitamin B12 supplementation on early infant neurocognitive outcomes: a randomized controlled clinical trial.Matern Child Nutr.2016;doi: 10.1111/mcn.12325.Siddiqua TJ, Ahmad SM, Ahsan KB, Rashid M, Roy A, Rahman SM,et al. Vitamin B12 supplementation during pregnancy and postpartum improves B12 status of both mothers and infants but vaccine response in mothers …