Randomised trial to assess benefits and safety of vitamin A supplementation linked to immunisation in early infancy
Randomised trial to assess benefits and safety of vitamin A supplementation linked to immunisation in early infancy
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DOI：
10.1016/s0140-6736(98)02487-8
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发表时间：
1998-10-17
期刊：
影响因子：
168.9
通讯作者：
Rivera, KB
中科院分区：
文献类型：
--
作者：
Martines, J;Underwood, B;Rivera, KB
在广泛推荐之前，需要评估与婴儿期免疫接种相关的维生素A补充剂的益处和安全性。我们评估了产妇产后和婴儿维生素A补充剂的安全性和效益管理的三个白喉，破伤风，百日咳（DPT）和脊髓灰质炎免疫接种和第四剂量与麻疹immunisation.Methods从1995年1月，我们招募了9424对来自加纳，印度和秘鲁在这个随机，双盲，安慰剂对照试验。维生素A组4716名婴儿的母亲接受了200 000 IU维生素A，他们的婴儿在第6、10和14周的前三次DPT/脊髓灰质炎免疫接种中各接受了25 000 IU维生素A。在对照组中，4708名母亲和她们的婴儿同时接受安慰剂。在9个月时，接种麻疹疫苗后，维生素A组的婴儿再给予25 000 IU的剂量，对照组的婴儿给予100 000 IU的维生素A。婴儿随访至12个月。主要结果指标为维生素A状况、急性毒性反应体征、人体测量指标和严重发病率。结果3933（93%）的4212名合格的婴儿维生素A和3938（93%）的4227名合格的对照组接受了所有四个研究剂量。在g月随访时，与对照组相比，维生素A组的维生素A缺乏症略有下降（血清视黄醇小于或等于0.70 μ mol/L 101 [29.9%] vs 122 [37.1%;差异的95%CI为-14.3%至-0.2%1]）。这种效应在9个月和12个月时不再明显，在整个研究期间，组间死亡率无显著差异。两组9月龄以下死亡的率比为0.96（95% CI 0.73 ~ 1.27）。干预没有影响人体测量的状态，或对整体或严重morphism.Interpretation的试验证实了干预的安全性，但没有显示出持续的好处，在维生素A的状态超过6个月或婴儿发病率。
Background The benefits and safety of vitamin A supplementation linked to immunisation in infancy need to be assessed before it can be widely recommended. We assessed the safety and benefits of maternal postpartum and infant vitamin A supplementation administered with each of the three diphtheria-tetanus-pertussis (DPT) and poliomyelitis immunisations and with a fourth dose with measles immunisation.Methods From January, 1995, we enrolled 9424 mother-infant pairs from Ghana, India, and Peru in this randomised, double-blind, placebo-controlled trial. 4716 mothers of infants in the vitamin A group received 200 000 IU vitamin A, and their infants were given 25 000 IU vitamin A with each of the first three doses of DPT/poliomyelitis immunisation at 6, 10, and 14 weeks. In the control group, 4708 mothers and their infants received placebo at the same times. At 9 months, with measles immunisation, infants in the vitamin A group were given a further dose of 25 000 IU and those in the control group received 100 000 IU vitamin A. Infants were followed up to age 12 months. The primary outcome measures were vitamin A status, signs of acute toxic effects, anthropometric indicators, and severe morbidity. Analysis was by intention to treat.Findings 3933 (93%) of the eligible 4212 infants on vitamin A and 3938 (93%) of the eligible 4227 controls received all four study doses. At the g-month follow-up, there was a small decrease in vitamin A deficiency in the vitamin A group compared with controls (serum retinol less than or equal to 0.70 mu mol/L 101 [29.9%] vs 122 [37.1%; 95% CI of the difference -14.3% to -0.2%1]). This effect was no longer apparent at 9 and 12 months, There were no significant between-group differences in mortality throughout the study. The rate ratio to compare all deaths up to age 9 months in the two groups was 0.96 (95% CI 0.73 to 1.27), Fewer than 1% of the infants had bulging fontanelle. The intervention had no effect on anthropometric status, or on overall or severe morbidity.Interpretation The trial confirmed the safety of the intervention, but shows no sustained benefits in terms of vitamin A status beyond age 6 months or infant morbidity.