Trial of Vitamin D in Maternal HIV Progression and Child Health

描述（由申请人提供）：项目的总体目标是研究维生素D3（胆钙化醇）作为一种简单、低成本的干预措施，在资源有限的环境下延长和改善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，我们建议进行一项随机、双盲、安慰剂对照试验的黄金标准研究。简而言之，我们将招募2300名怀孕12-27周感染艾滋病毒的孕妇参加坦桑尼亚达累斯萨拉姆的卫生管理与发展总统艾滋病紧急救援计划。同意参加试验的感染艾滋病毒的母亲将被随机分配，接受两组之一的口服补充方案：(a)每天服用含有3,000国际单位的维生素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。感染艾滋病毒的妇女和儿童将在定期研究访问和分娩期间进行随访，以评估主要试验终点(a)孕产妇艾滋病毒进展情况，(b)小胎龄婴儿，以及(c) 1岁儿童发育迟缓。其次，我们还将评估维生素D3对以下方面的影响：(i)母体CD4 t细胞重建，（ii）早产，（iii）低出生体重（<2500 g）， （iv）母婴艾滋病毒传播，以及(v)母婴甲状旁腺激素水平（PTH）。由于抗逆转录病毒治疗在全球范围内对感染艾滋病毒的妇女的覆盖范围正在迅速扩大，特别是由于B+方案的扩大，因此迫切需要这项随机试验的证据，而且治疗方案需要干预措施，以延长和改善感染艾滋病毒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.