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Abstract：
BACKGROUND: Young children in low- and middle-income countries frequently have inadequate vitamin B-12 (cobalamin) status. Poor folate status is also common and is associated with increased diarrheal and respiratory morbidity.
OBJECTIVE: The objective was to measure the effect of folic acid and/or vitamin B-12 administration on the incidence of diarrhea and acute lower respiratory tract infections.
METHODS: One thousand North Indian children (6-30 mo of age) were enrolled in a randomized, double-blind, placebo-controlled trial to receive 2 times the Recommended Dietary Allowance of folic acid and/or vitamin B-12 or placebo daily for 6 mo. Children were individually randomly assigned in a 1:1:1:1 ratio in blocks of 16. Primary outcomes were the number of episodes of acute lower respiratory infections, diarrhea, and prolonged diarrhea.
RESULTS: Folic acid and vitamin B-12 supplementation significantly improved vitamin B-12 and folate status, respectively. Neither folic acid nor vitamin B-12 administration reduced the incidence of diarrhea or lower respiratory infections. In comparison with placebo, children treated with folic acid alone or in combination with vitamin B-12 had a significantly higher risk of persistent diarrhea (OR: 2.1; 95% CI: 1.1, 3.8).
CONCLUSIONS: Folic acid or vitamin B-12 supplementation did not reduce the burden of common childhood infections. In view of the increased risk of diarrhea, the safety of folic acid supplements in young children should be further assessed. This trial was registered at www.clinicaltrials.gov as NCT00717730 and at www.ctri.nic.in as CTRI/2010/091/001090.
OBJECTIVE: The objective was to measure the effect of folic acid and/or vitamin B-12 administration on the incidence of diarrhea and acute lower respiratory tract infections.
METHODS: One thousand North Indian children (6-30 mo of age) were enrolled in a randomized, double-blind, placebo-controlled trial to receive 2 times the Recommended Dietary Allowance of folic acid and/or vitamin B-12 or placebo daily for 6 mo. Children were individually randomly assigned in a 1:1:1:1 ratio in blocks of 16. Primary outcomes were the number of episodes of acute lower respiratory infections, diarrhea, and prolonged diarrhea.
RESULTS: Folic acid and vitamin B-12 supplementation significantly improved vitamin B-12 and folate status, respectively. Neither folic acid nor vitamin B-12 administration reduced the incidence of diarrhea or lower respiratory infections. In comparison with placebo, children treated with folic acid alone or in combination with vitamin B-12 had a significantly higher risk of persistent diarrhea (OR: 2.1; 95% CI: 1.1, 3.8).
CONCLUSIONS: Folic acid or vitamin B-12 supplementation did not reduce the burden of common childhood infections. In view of the increased risk of diarrhea, the safety of folic acid supplements in young children should be further assessed. This trial was registered at www.clinicaltrials.gov as NCT00717730 and at www.ctri.nic.in as CTRI/2010/091/001090.
摘要：
背景：低收入和中等收入国家的幼儿经常缺乏维生素B-12（钴胺素）。叶酸状态差也很常见，并且与腹泻和呼吸道发病率增加有关。
目的：研究叶酸和/或维生素B-12给药对腹泻和急性下呼吸道感染发生率的影响。
方法：1000名北印度儿童（6-30个月大）被随机纳入，双盲,安慰剂对照试验，每天接受2倍推荐的叶酸和/或维生素B-12或安慰剂，持续6个月。儿童分别以1：1：1：1：1的比例随机分配，分为16个组。主要结果是急性下呼吸道感染的发作次数，腹泻,和长期腹泻。
结果：补充叶酸和维生素B-12显著改善了维生素B-12和叶酸的状态，分别。服用叶酸和维生素B-12均不能降低腹泻或下呼吸道感染的发生率。与安慰剂相比，单独使用叶酸或联合使用维生素B-12治疗的儿童发生持续性腹泻的风险明显较高(OR:2.1;95%CI:1.1,3.8).
结论：补充叶酸或维生素B-12并不能减轻儿童常见感染的负担。鉴于腹泻的风险增加，应进一步评估幼儿叶酸补充剂的安全性.该试验已在www上注册。clinicaltrials.gov作为NCT00717730和www。ctri.nic.在CTRI/2010/091/001090。
目的：研究叶酸和/或维生素B-12给药对腹泻和急性下呼吸道感染发生率的影响。
方法：1000名北印度儿童（6-30个月大）被随机纳入，双盲,安慰剂对照试验，每天接受2倍推荐的叶酸和/或维生素B-12或安慰剂，持续6个月。儿童分别以1：1：1：1：1的比例随机分配，分为16个组。主要结果是急性下呼吸道感染的发作次数，腹泻,和长期腹泻。
结果：补充叶酸和维生素B-12显著改善了维生素B-12和叶酸的状态，分别。服用叶酸和维生素B-12均不能降低腹泻或下呼吸道感染的发生率。与安慰剂相比，单独使用叶酸或联合使用维生素B-12治疗的儿童发生持续性腹泻的风险明显较高(OR:2.1;95%CI:1.1,3.8).
结论：补充叶酸或维生素B-12并不能减轻儿童常见感染的负担。鉴于腹泻的风险增加，应进一步评估幼儿叶酸补充剂的安全性.该试验已在www上注册。clinicaltrials.gov作为NCT00717730和www。ctri.nic.在CTRI/2010/091/001090。
