Abstract
ObjectiveTo determine if a protein-calorie supplement (PCS) plus a micronutrient supplement (MNS) improves outcomes for HIV-infected lactating women and their infants.DesignRandomized, controlled trial.SettingDar es Salaam, TanzaniaSubjects, participantsPregnant HIV-infected women enrolled in PMTCT programs who intended to breastfeed for 6 months.InterventionRandomization 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.ResultsPCS 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).ConclusionsIn 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.Trial registrationClinical Trials.Gov NCT01461863.
Highlights
An estimated 24.7 million people living with HIV reside in sub-Saharan Africa representing 70% of the global HIV burden, and over 90% of HIV-infected women reside in Africa [1]
protein-calorie supplement (PCS) resulted in significant increases in daily energy intake compared to micronutrient supplement (MNS) at all time points; and increases in daily protein intake
Infant weight at 3 months did not differ between PCS and MNS groups: 5.63 kg vs 5.99 kg (p = 0.07)
Summary
An estimated 24.7 million people living with HIV reside in sub-Saharan Africa representing 70% of the global HIV burden, and over 90% of HIV-infected women reside in Africa [1]. Malnutrition and HIV, independently and synergistically, weaken the immune system leading to increased susceptibility to infection and poorer health outcomes [3, 4]. Pregnant and lactating HIV-infected women and their infants living in resource poor settings may be at risk for poorer HIV outcomes due to underlying food insecurity and increased nutrient needs during pregnancy and lactation [5, 6] Dietary deficiencies of both micro- and macro-nutrients have been described in these groups and have led to trials of both types of dietary supplements [3, 7,8,9]. Trials of micronutrient supplements in HIV-positive pregnant women have shown improvement in maternal and infant health outcomes [10, 11]. Few randomized controlled trials have evaluated macronutrient supplementation in HIV-infected lactating women
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