Efficacy of a High-Dose in Addition to Daily Low-Dose Vitamin A in Children Suffering from Severe Acute Malnutrition with Other Illnesses

BackgroundEfficacy of high-dose vitamin A (VA) in children suffering from severe acute malnutrition (SAM) has recently been questioned. This study compared the efficacy of a single high-dose (200,000 IU) in addition to daily low-dose (5000 IU) VA in the management of children suffering from SAM with diarrhea and/or acute lower respiratory tract infection (ALRI). MethodsIn a randomized, double-blind, controlled clinical trial in icddr,b, Bangladesh during 2005–07, children aged 6–59 months with weight-for-height ResultsA total 260 children (130 in each group) were enrolled. All had diarrhea, 54% had concomitant ALRI, 50% had edema, 48.5% were girl with a mean±SD age of 16±10 months. None had clinical signs of VA deficiency. Mean±SD baseline serum retinol was 13.15±9.28 µg/dl, retinol binding protein was 1.27±0.95 mg/dl, and pre-albumin was 7.97±3.96 mg/dl. Median (inter quartile range) of C-reactive protein was 7.8 (2.1, 22.2) mg/L. Children of the two groups did not differ in any baseline characteristic. Over the 15 days treatment period resolution of diarrhea, ALRI, edema, anthropometric changes, and biochemical indicators of VA were similar between the groups. The high-dose VA supplementation in children with SAM did not show any adverse event. ConclusionsEfficacy of daily low-dose VA compared to an additional single high-dose was not observed to be better in the management of children suffering from SAM with other acute illnesses. A single high-dose VA may be given especially where the children with SAM may leave the hospital/treatment center early. Trial RegistrationClinicalTrials.gov NCT00388921

背景 重症急性营养不良（Severe Acute Malnutrition, SAM）患儿补充大剂量维生素A（Vitamin A, VA）的疗效近期受到学界质疑。本研究针对合并腹泻和/或急性下呼吸道感染（Acute Lower Respiratory Tract Infection, ALRI）的SAM患儿，对比了每日低剂量（5000 IU）VA基础上追加单次大剂量（200000 IU）VA的治疗效果。
方法 2005年至2007年于孟加拉国国际腹泻病研究中心（icddr,b）开展一项随机双盲对照临床试验，纳入年龄6~59个月、体重身高比[原文此处纳入标准表述不完整]的患儿。
结果 本研究共纳入260例患儿（每组130例）。所有患儿均合并腹泻，其中54%同时合并ALRI，50%存在水肿，女性患儿占比48.5%，受试者平均年龄为16±10个月。所有患儿均无VA缺乏的临床体征。基线血清视黄醇水平为13.15±9.28 µg/dl，视黄醇结合蛋白水平为1.27±0.95 mg/dl，前白蛋白水平为7.97±3.96 mg/dl；C反应蛋白的中位数（四分位间距）为7.8（2.1，22.2）mg/L。两组患儿的所有基线特征均无显著差异。在15天的治疗周期内，两组患儿的腹泻、ALRI、水肿症状缓解情况，人体测量学指标变化及VA相关生化指标均无显著差异。追加大剂量VA的SAM患儿未出现任何不良事件。
结论 相较于仅每日给予低剂量VA，追加单次大剂量VA并未在合并其他急性疾病的SAM患儿的治疗中展现出更优疗效。对于可能提前离开医院/治疗中心的SAM患儿，可考虑给予单次大剂量VA补充。
试验注册 ClinicalTrials.gov NCT00388921