A lipid-based nutrient supplement mitigates weight loss among HIV-infected women in a factorial randomized trial to prevent mother-to-child transmission during exclusive breastfeeding

Abstract

Background: Breastfeeding increases metabolic demands on the mother, and excessive postnatal weight loss increases maternal mortality.

Objective: We evaluated the efficacy of a lipid-based nutrient supplement (LNS) for prevention of excess weight loss in breastfeeding, HIV-infected women.

Design: The BAN (Breastfeeding, Antiretrovirals, and Nutrition) Study was a randomized controlled trial in Lilongwe, Malawi. At delivery, HIV-infected mothers and their infants were randomly assigned according to a 2-arm (with and without LNS) by 3-arm (maternal triple-antiretroviral prophylaxis, infant-nevirapine prophylaxis, or neither) factorial design. The 28-wk LNS intervention provided daily energy (700 kcal), protein (20 g), and micronutrients (except for vitamin A) to meet lactation needs. Women were counseled to breastfeed exclusively for 24 wk and to wean by 28 wk. Weight change (0-28 wk) was tested in an intent-to-treat analysis by using 2-factor ANOVA and with longitudinal mixed-effects models.

Results: At delivery, the LNS (n = 1184) and control (n = 1185) groups had similar mean weights and BMIs. Women receiving the LNS had less 0-28-wk weight loss (-1.97 compared with -2.56 kg, P = 0.003). This difference remained significant after adjustment for maternal antiretroviral drug therapy and baseline BMI. Women receiving antiretroviral drugs had more weight loss than did those not receiving antiretroviral drugs (-2.93 compared with -1.90 kg, P < 0.001). The benefit of the LNS for reducing weight loss was observed both in those receiving antiretroviral drugs (-2.56 compared with -3.32 kg, P = 0.019) and in those not receiving antiretroviral drugs (-1.63 compared with -2.16 kg, P = 0.034).

Conclusions: The LNS reduced weight loss among HIV-infected, breastfeeding women, both in those taking maternal antiretroviral prophylaxis to prevent postnatal HIV transmission and in those not receiving antiretroviral prophylaxis. Provision of an LNS may benefit HIV-infected, breastfeeding women in resource-limited settings. This trial was registered at clinicaltrials.gov as NCT00164762.

FIGURE 1.

Flow of HIV-infected participants through each stage of the BAN Study. ¹Prenatal and postnatal eligibility criteria are described in Subjects and Methods. ^2aThe 1184 women randomly assigned to receive the LNS were also randomly assigned to 1 of 3 antiretroviral interventions for prevention of postnatal HIV transmission: 424 to the maternal antiretroviral arm, 426 to the infant nevirapine arm, and 334 to the control arm; ^2bthe 1185 women in the LNS control arm were also randomly assigned to 1 of the 3 antiretroviral arms: 425 to the maternal antiretroviral arm, 426 to the infant nevirapine arm, and 334 to the control arm. BAN, Breastfeeding, Antiretroviral, and Nutrition; LNS, lipid-based nutrient supplement.

FIGURE 2.

Mean (±SE) cumulative maternal weight loss by random assignment to the LNS and weeks since delivery among BAN Study participants. The mean (±SE) weight loss was calculated from delivery cumulatively at each visit and includes data for all women with at least one weight measurement (n = 1182 in the LNS intervention arm, n = 1181 in the control arm). BAN, Breastfeeding, Antiretroviral, and Nutrition; LNS, lipid-based nutrient supplement.

FIGURE 3.

Predicted maternal weight change over weeks since delivery by random assignment to the LNS and maternal antiretroviral interventions in the BAN Study. Predicted curves from a mixed-effects model containing study visit (P < 0.001), nutritional supplement (P = 0.009), maternal antiretroviral drugs (P = 0.025), BMI at delivery (P < 0.001), and 2-way interactions between study visit and nutritional supplement (P < 0.001), between study visit and maternal antiretroviral drugs (P < 0.001), and between nutritional supplement and maternal antiretroviral drugs (P = 0.16). The 3-way interaction between study visit, maternal antiretroviral drugs, and nutritional supplement was not significant (P = 0.81) and was not included in the final model. Data from all women with at least one weight measurement were included (LNS, maternal antiretroviral drugs: n = 423; LNS, no maternal antiretroviral drugs: n = 759; no LNS, maternal antiretroviral drugs: n = 424; and no LNS, no maternal antiretroviral drugs: n = 757). BAN, Breastfeeding, Antiretroviral, and Nutrition; LNS, lipid-based nutrient supplement.