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一种维生素D3(胆钙化醇)，作为一种简单和低成本的干预措施，在资源有限的情况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，我们建议采用随机、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周的艾滋病毒感染孕妇参加坦桑尼亚达累斯萨拉姆的管理和发展健康(MDH)总统艾滋病紧急救援计划(PEPFAR)计划。同意参加试验的感染艾滋病毒的母亲将被随机分成两组，接受两组中的一种口服补充剂：(A)每天服用3000国际单位的维生素D3口服补充剂，直到产后12个月；或(B)每天服用安慰剂补充剂，直到产后12个月。感染艾滋病毒的妇女和儿童将在定期研究访问以及分娩期间接受跟踪，以评估主要试验终点(A)产妇艾滋病毒进展，(B)小于胎龄儿，和(C)1岁儿童发育迟缓。其次，我们还将评估维生素D3对(I)母体CD4T细胞重建，(Ii)早产，(Iii)低出生体重(2500克)，(Iv)艾滋病毒母婴传播，以及(V)母婴甲状旁腺激素水平(PTH)的影响。迫切需要这项随机试验的证据，因为全球艾滋病毒感染妇女的抗逆转录病毒治疗覆盖面正在迅速扩大，特别是由于B+选择的扩大，治疗计划需要干预措施来延长和改善艾滋病毒感染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.