Trial of Vitamin D in Maternal HIV Progression and Child Health

描述（由申请人提供）：总体项目目标是研究维生素D3（胆钙化醇）作为一种简单且低成本的干预措施，以延长和改善资源有限环境中感染艾滋病毒的孕妇及其子女的生活质量。为了达到这些目标，我们提出了一个金标准的调查与随机，双盲，安慰剂对照试验。 简而言之，我们将招募2300名妊娠12-27周的HIV感染孕妇，这些孕妇参加了坦桑尼亚达累斯萨拉姆的“健康管理与发展（MDH）总统艾滋病紧急救援计划（PEPFAR）”。同意参加试验的HIV感染母亲将随机接受两组之一的口服补充剂方案：（a）每天服用含3，000 IU的维生素D3口服补充剂，直至产后12个月，或（B）每天服用安慰剂补充剂，直至产后12个月。将在定期研究访视以及分娩和分娩期间对HIV感染的妇女和儿童进行随访，以评估主要试验终点（a）母体HIV进展，（B）小于胎龄儿，和（c）1岁时儿童发育迟缓。其次，我们还将评估维生素D3对（i）母体CD 4 T细胞重建，（ii）早产，（iii）低出生体重（<2500 g），（iv）母婴传播HIV和（v）母婴甲状旁腺激素水平（PTH）的影响。这项随机试验的证据是迫切需要的，因为ART覆盖率正在迅速扩大全球艾滋病毒感染的妇女，特别是由于扩大选项B+，治疗方案需要干预措施，以延长和改善艾滋病毒感染的孕妇及其子女的生活质量。

DESCRIPTION (provided by applicant): The overall project goal is to investigate a vitamin D3 (cholecalciferol) as a simple and low cost intervention to prolong and improve quality of life for HIV-infected pregnant women and their children in resource limited settings. In order to meet these goals we are proposing a gold standard investigation with a randomized, double-blind, placebo-controlled trial. Briefly, we will enroll 2300 HIV-infected pregnant women at 12-27 weeks gestation who are enrolled in the Management and Development for Health (MDH) President's Emergency Plan for AIDS Relief (PEPFAR) program in Dar-es-Salaam, Tanzania. HIV-infected mothers who consent for enrollment in the trial will be randomized to receive an oral supplement regimen of one of two groups: (a) vitamin D3 oral supplements containing 3,000 IU taken daily until 12 months post-partum or (b) placebo supplements taken daily until 12 months post- partum. HIV-infected women and children will be followed at regular study visits and during labor and delivery to assess the primary trial endpoints (a) maternal HIV progression, (b) small- for-gestational age infants, and (c) child stunting at 1 year of age. Secondarily, we will also assess the effect of vitamin D3 on (i) maternal CD4 T-cell reconstitution, (ii) preterm birth, (iii) low birth weight (<2500 g), (iv) mother to child transmision of HIV, and (v) maternal and child parathyroid hormone levels (PTH). Evidence from this randomized trial is urgently needed since ART coverage is rapidly expanding globally for HIV-infected women, particularly due to expansion of Option B+, and treatment programs are in need of interventions to prolong and improve the quality of life for HIV-infected pregnant women and their children.