Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Geisel School of Medicine at Dartmouth and Dartmouth-Hitchcock Medical Center, Lebanon, NH, United States of America.
PLoS One. 2018 Oct 11;13(10):e0201038. doi: 10.1371/journal.pone.0201038. eCollection 2018.
To determine if a protein-calorie supplement (PCS) plus a micronutrient supplement (MNS) improves outcomes for HIV-infected lactating women and their infants.
Randomized, controlled trial.
Dar es Salaam, Tanzania.
SUBJECTS, PARTICIPANTS: Pregnant HIV-infected women enrolled in PMTCT programs who intended to breastfeed for 6 months.
Randomization 1:1 to administration of a PCS plus MNS versus MNS alone among 96 eligible women beginning in the third trimester and continuing for 6 months of breast-feeding.
MAIN OUTCOME MEASURE(S): Primary: infant weight at 3 months. Secondary: maternal BMI at 6 months.
PCS resulted in significant increases in daily energy intake compared to MNS at all time points (range of differences: +388-719 Kcal); and increases in daily protein intake (range of differences: +22-33 gm). Infant birth weight (excluding twins) was higher in the PCS than MNS groups: 3.30 kg vs 3.04 kg (p = 0.04). Infant weight at 3 months did not differ between PCS and MNS groups: 5.63 kg vs 5.99 kg (p = 0.07). Maternal BMI at 6 months did not differ between PCS and MNS groups: 24.3 vs 23.8 kg/m2 (p = 0.68). HIV transmission occurred in 0 infants in the PCS group vs 4 in the MNS group (p = 0.03).
In comparison to MNS the PCS + MNS intervention was well tolerated, increased maternal energy and protein intake, and increased infant birth weight, but not weight at 3 months or maternal BMI at 6 months. Reduced infant HIV transmission in the PCS + MNS group was observed.
Clinical Trials.Gov NCT01461863.
确定蛋白质-热量补充剂（PCS）加微量营养素补充剂（MNS）是否能改善感染 HIV 的哺乳期妇女及其婴儿的结局。
随机对照试验。
坦桑尼亚达累斯萨拉姆。
受试者、参与者：参加母婴传播预防项目的、打算母乳喂养 6 个月的 HIV 感染孕妇。
随机分组，96 名符合条件的孕妇中，1:1 分入 PCS+MNS 组或 MNS 组，从妊娠晚期开始，持续 6 个月的母乳喂养。
主要指标：婴儿 3 个月时的体重。次要指标：母亲 6 个月时的 BMI。
与 MNS 组相比，PCS 组在所有时间点的每日能量摄入量均显著增加（差异范围：+388-719 Kcal）；并且每日蛋白质摄入量也增加（差异范围：+22-33 gm）。PCS 组婴儿出生体重（不包括双胞胎）高于 MNS 组：3.30 kg 比 3.04 kg（p=0.04）。婴儿 3 个月时的体重在 PCS 组与 MNS 组之间无差异：5.63 kg 比 5.99 kg（p=0.07）。6 个月时母亲的 BMI 在 PCS 组与 MNS 组之间无差异：24.3 比 23.8 kg/m2（p=0.68）。PCS 组中没有婴儿发生 HIV 传播，而 MNS 组中有 4 例（p=0.03）。
与 MNS 相比，PCS+MNS 干预措施耐受性良好，增加了母亲的能量和蛋白质摄入，增加了婴儿的出生体重，但不能增加婴儿 3 个月时的体重或 6 个月时的母亲 BMI。在 PCS+MNS 组观察到婴儿 HIV 传播减少。
ClinicalTrials.gov NCT01461863。
