Department of Paediatrics and Child Health, Makerere University, Kampala, Uganda.
J Int AIDS Soc. 2010 Jun 3;13:18. doi: 10.1186/1758-2652-13-18.
Micronutrient deficiencies compromise the survival of HIV-infected children in low-income countries. We assessed the effect of multiple micronutrient supplementation on the mortality of HIV-infected children in Uganda.
In a randomized, controlled trial, 847 children aged one to five years and attending HIV clinics in Uganda were stratified by antiretroviral therapy (ART, n = 85 versus no ART, n = 762). The children were randomized to six months of either: twice the recommended dietary allowance of 14 micronutrients as the intervention arm (vitamins A, B1, B2, niacin, B6, B12, C, D and E, folate, zinc, copper, iodine and selenium); or the standard recommended dietary allowance of six multivitamins (vitamins A, D2, B1, B2, C and niacin) as a comparative "standard-of-care" arm. Mortality was analyzed at 12 months of follow up using Kaplan Meier curves and the log rank test.
Mortality at 12 months was 25 out of 426 (5.9%) children in the intervention arm and 28 out of 421 (6.7%) in the comparative arms: risk ratio 0.9 (95% CI 0.5 - 1.5). Two out of 85 (2.4%) children in the ART stratum died compared with 51 out of 762 (6.7%) in the non-ART stratum. Of those who died in the non-ART stratum, 25 of 383 (6.5%) were in the intervention arm and 26 of 379 (6.9%) in the comparative arm; risk ratio 1.0 (95% CI 0.6 - 1.6). There was no significant difference in survival at 12 months (p = 0.64, log rank test). In addition, there was no significant difference in mean weight-for-height at 12 months; 0.70 +/- 1.43 (95% CI 0.52 - 0.88) for the intervention versus 0.59 +/- 1.15 (95% CI 0.45 - 0.75) in the comparative arm. The mean CD4 cell count; 1024 +/- 592 (95% CI 942 - 1107) versus 1060 +/- 553 (95% CI 985 - 1136) was also similar between the two groups.
Twice the recommended dietary allowance of 14 micronutrients compared with a standard recommended dietary allowance of six multivitamins for six months was well tolerated, but it did not significantly alter mortality, growth or CD4 counts. Future intervention studies should carefully consider: (1) the composition and dosing of the supplements; and (2) the power needed to detect a difference between arms.
ClinicalTrials.gov Identifier: NCT00122941.
微量营养素缺乏会危及低收入国家感染艾滋病毒的儿童的生存。我们评估了多种微量营养素补充对乌干达感染艾滋病毒儿童死亡率的影响。
在一项随机对照试验中,847 名年龄在 1 至 5 岁之间、在乌干达艾滋病毒诊所就诊的儿童按抗逆转录病毒治疗(ART,n = 85 与无 ART,n = 762)分层。儿童随机分为六个月:接受推荐的 14 种微量营养素的两倍推荐膳食摄入量作为干预组(维生素 A、B1、B2、烟酸、B6、B12、C、D 和 E、叶酸、锌、铜、碘和硒);或作为比较“标准护理”臂的六种复合维生素的标准推荐膳食允许量(维生素 A、D2、B1、B2、C 和烟酸)。使用 Kaplan-Meier 曲线和对数秩检验分析 12 个月的死亡率。
在 12 个月的随访中,干预组有 25/426(5.9%)名儿童死亡,对照组有 28/421(6.7%)名儿童死亡:风险比为 0.9(95%CI 0.5-1.5)。在接受 ART 治疗的儿童中,有 2/85(2.4%)名儿童死亡,而在未接受 ART 治疗的儿童中,有 51/762(6.7%)名儿童死亡。在非 ART 组死亡的儿童中,干预组有 25/383(6.5%)例,对照组有 26/379(6.9%)例;风险比为 1.0(95%CI 0.6-1.6)。12 个月时的生存率无显著差异(p = 0.64,对数秩检验)。此外,12 个月时的平均体重身高比也无显著差异;干预组为 0.70 +/- 1.43(95%CI 0.52-0.88),对照组为 0.59 +/- 1.15(95%CI 0.45-0.75)。两组的平均 CD4 细胞计数也相似;干预组为 1024 +/- 592(95%CI 942-1107),对照组为 1060 +/- 553(95%CI 985-1136)。
与六个月的标准推荐的六种复合维生素相比,推荐的 14 种微量营养素的两倍推荐膳食摄入量耐受性良好,但不能显著降低死亡率、生长或 CD4 计数。未来的干预研究应仔细考虑:(1)补充剂的组成和剂量;(2)检测臂之间差异所需的能力。
ClinicalTrials.gov 标识符:NCT00122941。