Idindili Boniphace, Masanja Honarati, Urassa Honorathy, Bunini Wilbert, van Jaarsveld Paul, Aponte John J, Kahigwa Elizeus, Mshinda Hassan, Ross David, Schellenberg David M
Ifakara Health Research and Development Centre, Ifakara, Tanzania.
Am J Clin Nutr. 2007 May;85(5):1312-9. doi: 10.1093/ajcn/85.5.1312.
Vitamin A supplementation reduces morbidity and mortality in children living in areas endemic for vitamin A deficiency. Routine vitamin A supplementation usually starts only at age 9 mo, but high rates of illness and mortality are seen in the first months of life.
The objective of the study was to evaluate the safety and efficacy of vitamin A supplementation at the same time as routine vaccination in infants aged 1-3 mo.
We recruited 780 newborn infants and their mothers to a randomized double-blind controlled trial in Ifakara in southern Tanzania. In one group, mothers received 60,000 microg vitamin A palmitate shortly after delivery, and their infants received 7500 microg at the same time as vaccinations given at approximately 1, 2, and 3 mo of age. In the other group, mothers received a second 60,000-microg dose when their infant was aged 1 mo, and their infants received 15,000 microg at the same time as the routine vaccinations. VAD was defined as a modified relative dose-response test result of >or=0.060.
High-dose vitamin A supplementation was well tolerated. The relative risk of VAD at 6 mo in the high-dose group compared with the lower dose group was 0.91 (95% CI: 0.76, 1.09; P=0.32). Serum retinol and incidence of illness did not differ significantly between the 2 groups. Some vitamin A capsules degraded toward the end of the study.
Doubling the doses of vitamin A to mothers and their young infants is safe but unlikely to reduce short-term morbidity or to substantially enhance the biochemical vitamin A status of infants at age 6 mo. The stability of vitamin A capsules merits further investigation.
补充维生素A可降低生活在维生素A缺乏流行地区儿童的发病率和死亡率。常规维生素A补充通常在9月龄时才开始，但在生命的最初几个月中疾病和死亡率很高。
本研究的目的是评估1至3月龄婴儿在进行常规疫苗接种时同时补充维生素A的安全性和有效性。
我们在坦桑尼亚南部的伊法卡拉招募了780名新生儿及其母亲参与一项随机双盲对照试验。在一组中，母亲在分娩后不久接受60000微克棕榈酸视黄酯，其婴儿在大约1、2和3月龄接种疫苗时同时接受7500微克。在另一组中，母亲在其婴儿1月龄时接受第二剂60000微克剂量，其婴儿在进行常规疫苗接种时同时接受15000微克。维生素A缺乏定义为改良相对剂量反应试验结果≥0.060。
高剂量维生素A补充耐受性良好。高剂量组与低剂量组相比，6月龄时维生素A缺乏的相对风险为0.91（95%CI：0.76，1.09；P=0.32）。两组间血清视黄醇水平和发病率无显著差异。在研究接近尾声时，一些维生素A胶囊出现降解。
母亲及其幼儿的维生素A剂量加倍是安全的，但不太可能降低短期发病率或显著提高6月龄婴儿的维生素A生化状态。维生素A胶囊的稳定性值得进一步研究。
