CIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Division of Infectious Diseases, Department of Medicine, University of Ottawa at the Ottawa Hospital, Ottawa, Ontario, Canada.
CIHR Canadian HIV Trials Network (CTN), Vancouver, British Columbia, Canada ; Clinical Epidemiology Program, University of Ottawa at The Ottawa Hospital Research Institute (OHRI), Ottawa, Ontario, Canada.
PLoS One. 2014 Jan 21;9(1):e85607. doi: 10.1371/journal.pone.0085607. eCollection 2014.
The MAINTAIN study is an on-going RCT comparing high-dose micronutrient and anti-oxidant supplementation versus recommended daily allowance (RDA) vitamins in slowing HIV immune deficiency progression in ART-naïve people with HIV infection.
We planned analysis of the first 127 participants to determine the baseline prevalence of serum micronutrient deficiencies and correlates, as well as tolerance and adherence to study interventions.
Participants receive eight capsules twice daily of 1) high-dose or 2) RDA supplements for two years and are followed-up quarterly for measures of immune deficiency progression, safety and tolerability. Regression analysis was used to identify correlates of micronutrient levels at baseline. Adherence was measured by residual pill count, self-report using the General Treatment Scale (GTS) and short-term recall HIV Adherence Treatment Scale (HATS).
Prior micronutrient supplementation (within 30 days) was 27% at screening and 10% of study population, and was not correlated with baseline micronutrient levels. Low levels were frequent for carotene (24%<1 nmol/L), vitamin D (24%<40 nmol/L) and serum folate (20%<15 nmol/L). The proportion with B12 deficiency (<133 pmol/L) was 2.4%. Lower baseline levels of B12 correlated lower baseline CD4 count (r = 0.21, p = 0.02) with a 21 pmol/L reduction in B12 per 100 cells/µL CD4. Vitamin D levels were higher in men (p<0.001). After a median follow-up of 1.63 years, there were 19 (15%) early withdrawals from the study treatment. Mean treatment adherence using pill count was 88%. Subjective adherence by the GTS was 81% and was moderately but significantly correlated with pill count (r = 0.29, p<0.001). Adherence based on short-term recall (HATS) was >80% in 75% of participants.
Micronutrient levels in asymptomatic HIV+ persons are in keeping with population norms, but micronutrient deficiencies are frequent. Adherence levels are high, and will permit a valid evaluation of treatment effects.
ClinicalTrials.gov NCT00798772.
MAINTAIN 研究是一项正在进行的 RCT，比较了高剂量微量营养素和抗氧化剂补充剂与抗逆转录病毒治疗（ART）初治 HIV 感染者的推荐日摄入量（RDA）维生素，以减缓 HIV 免疫缺陷的进展。
我们计划分析前 127 名参与者，以确定血清微量营养素缺乏的基线患病率以及相关性，以及对研究干预的耐受性和依从性。
参与者每天接受两次 8 粒胶囊，1）高剂量或 2）RDA 补充剂，持续两年，并每季度进行免疫缺陷进展、安全性和耐受性的随访。回归分析用于确定基线时微量营养素水平的相关性。依从性通过残留药丸计数、使用一般治疗量表（GTS）的自我报告和短期回忆 HIV 依从性治疗量表（HATS）进行测量。
筛选时，参与者中有 27%（27%）曾在前 30 天内接受过微量营养素补充剂，而研究人群中有 10%（10%）曾接受过补充剂，这与基线微量营养素水平无相关性。类胡萝卜素（24%<1 nmol/L）、维生素 D（24%<40 nmol/L）和血清叶酸（20%<15 nmol/L）水平较低的情况很常见。B12 缺乏（<133 pmol/L）的比例为 2.4%。较低的基线 B12 水平与较低的基线 CD4 计数相关（r = 0.21，p = 0.02），每 100 个 CD4 细胞/µL B12 减少 21 pmol/L。男性的维生素 D 水平较高（p<0.001）。在中位随访 1.63 年后，有 19 名（15%）参与者提前退出研究治疗。使用药丸计数的平均治疗依从率为 88%。GTS 的主观依从性为 81%，与药丸计数中度但显著相关（r = 0.29，p<0.001）。在 75%的参与者中，基于短期回忆（HATS）的依从率>80%。
无症状 HIV+人群的微量营养素水平符合人群正常值，但微量营养素缺乏很常见。依从水平较高，将允许对治疗效果进行有效评估。
ClinicalTrials.gov NCT00798772。
