Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial.
Multivitamin supplementation in HIV infected adults initiating antiretroviral therapy in Uganda: the protocol for a randomized double blinded placebo controlled efficacy trial.
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乌干达启动抗逆转录病毒疗法的艾滋病毒感染成年人的多种维生素补充剂：一项随机双盲安慰剂控制疗效试验的方案。
DOI：
10.1186/1471-2334-12-304
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发表时间：
2012-11-15
影响因子：
3.7
通讯作者：
Fawzi WW
中科院分区：
文献类型：
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作者：
Guwatudde D;Ezeamama AE;Bagenda D;Kyeyune R;Wabwire-Mangen F;Wamani H;Mugusi F;Spiegelman D;Wang M;Manabe YC;Fawzi WW
已发现在HAART前使用多种维生素补充剂可降低病毒载量，增强免疫反应，并通常改善HIV感染成人的临床结果。然而，免疫重建是不完全的，尽管有HAART，仍会发生显著的死亡率和机会性感染。目前还没有足够的研究信息来说明复合维生素补充剂作为辅助治疗是否对服用HAART的HIV感染者有益。我们建议在乌干达接受HAART治疗的HIV感染成人中评估微量营养素（包括维生素B复合物、C和E）的单一推荐每日摄入量（RDA）在减缓疾病进展方面的疗效。我们采用随机、双盲、安慰剂对照试验设计。符合条件的患者是年龄至少18岁的HIV阳性成人，并随机接受安慰剂或多种维生素，包括以下维生素的单一RDA：1.4 mg B1，1.4 mg B2，1.9 mg B6，2.6 mcg B12，18 mg烟酸，70 mg C，10 mg E和0.4 mg叶酸。对参与者进行长达18个月的随访，并在基线、6个月、12个月和18个月进行评估。这项研究主要是检查对免疫重建，体重增加和生活质量的影响。此外，我们将检查对其他次要结局的影响，包括新发或复发性疾病进展事件的风险，包括全因死亡率;从一线治疗到二线治疗的ARV方案变化;以及由周围神经病变、重度贫血或腹泻指示的其他不良事件。这项试验的进行提供了一个机会，以评估这种负担得起的辅助治疗（多种维生素补充剂）在发展中国家接受HAART治疗的HIV感染成人中的潜在益处。临床试验注册-URL：http://www.clinicaltrials.gov。唯一标识符：NCT 01228578
Use of multivitamin supplements during the pre-HAART era has been found to reduce viral load, enhance immune response, and generally improve clinical outcomes among HIV-infected adults. However, immune reconstitution is incomplete and significant mortality and opportunistic infections occur in spite of HAART. There is insufficient research information on whether multivitamin supplementation may be beneficial as adjunct therapy for HIV-infected individuals taking HAART. We propose to evaluate the efficacy of a single recommended daily allowance (RDA) of micronutrients (including vitamins B-complex, C, and E) in slowing disease progression among HIV-infected adults receiving HAART in Uganda. We are using a randomized, double-blind, placebo-controlled trial study design. Eligible patients are HIV-positive adults aged at least 18 years, and are randomized to receive either a placebo; or multivitamins that include a single RDA of the following vitamins: 1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 2.6 mcg B12, 18 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid. Participants are followed for up to 18 months with evaluations at baseline, 6, 12 and 18 months. The study is primarily powered to examine the effects on immune reconstitution, weight gain, and quality of life. In addition, we will examine the effects on other secondary outcomes including the risks of development of new or recurrent disease progression event, including all-cause mortality; ARV regimen change from first- to second-line therapy; and other adverse events as indicated by incident peripheral neuropathy, severe anemia, or diarrhea. The conduct of this trial provides an opportunity to evaluate the potential benefits of this affordable adjunct therapy (multivitamin supplementation) among HIV-infected adults receiving HAART in a developing country setting. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01228578