The effect of providing lipid-based nutrient supplements on morbidity in rural Malawian infants and young children: a randomized controlled trial.

OBJECTIVE: Safety of home fortificants in children is uncertain in areas where infections are common. We tested the hypothesis that provision of lipid-based nutrient supplements (LNS) containing Fe does not increase infectious morbidity in children. DESIGN: Randomized controlled trial. Infants were randomised to receive 10, 20 or 40 g LNS/d; or no supplement until age 18 months. All LNS contained 6 mg Fe/d. Morbidity outcomes (serious adverse events, non-scheduled visits and guardian-reported morbidity episodes) were compared between control and intervention groups using a non-inferiority margin of 20 %. SETTING: Namwera and Mangochi catchment areas in rural Malawi. SUBJECTS: Infants aged 6 months (n 1932). RESULTS: The enrolled 1932 infants contributed 1306 child-years of follow-up. Baseline characteristics were similar across groups. Compared with the control group, the relative risk (95 % CI) of serious adverse events was 0·71 (0·48, 1·07), 0·67 (0·48, 0·95) and 0·91 (0·66, 1·25) in 10, 20 and 40 g LNS/d groups, respectively. The incidence rate ratio (95 % CI) of non-scheduled visits due to malaria was 1·10 (0·88, 1·37), 1·08 (0·89, 1·31) and 1·21 (1·00, 1·46), and of guardian-reported morbidity episodes was 1·04 (0·96, 1·11), 1·03 (0·97, 1·10) and 1·04 (0·97, 1·10), in the respective LNS groups. CONCLUSIONS: Provision of 10 and 20 g LNS/d containing 6 mg Fe/d did not increase morbidity in the children. Provision of 40 g LNS/d did not affect guardian-reported illness episodes but may have increased malaria-related non-scheduled visits.

Malawian Mothers Consider Lipid-Based Nutrient Supplements Acceptable for Children throughout a 1-Year Intervention, but Deviation from User Recommendations Is Common.

BACKGROUND: Lipid-based nutrient supplements (LNSs) offer a vehicle to improve children's diets in low-income countries where complementary foods are typically deficient in essential nutrients. Sustained acceptability by the intended users is essential for achieving growth-promoting effects. OBJECTIVE: We aimed to determine the sustained acceptability of LNSs among 6- to 18-mo-old children in Malawi. METHODS: In the context of a trial testing the growth-promoting effect of different formulations and doses of LNSs, we delivered LNSs to the homes of the children biweekly according to the randomization protocol. We defined acceptability to include adherence to feeding recommendations and mothers' experiences of feeding LNSs to their child. We conducted brief interviews each week with the mothers. At 2 time points we conducted knowledge, attitudes, and practices (KAP) interviews. In addition, we conducted repeated in-depth interviews with a subset of mothers. RESULTS: Of the 1612 children who received the LNS intervention, we analyzed adherence data from 1478 (91.7%) children and KAP data at 2 time points (child's age of 12 and 18 mo) from 839 (52.1%) of the children. The mean ± SD overall adherence (proportion of days when the study child reportedly consumed LNSs considering only those weeks when the supplement had been successfully delivered to the home) was 92.4 ± 9.6%, and there was no difference between children receiving milk-containing or milk-free LNSs. There was also no increasing or decreasing trend over time in any of the groups. Sharing and deviation from other feeding recommendations were common. Maternal experiences were mostly very positive. CONCLUSIONS: The acceptability of LNS products was good and was sustained for 12 mo in this rural Malawian population. However, sharing of the products with family members and deviation from other feeding recommendations were frequent, which means that individually targeted children were likely to receive less than the intended dose of the LNS. This trial was registered at clinicaltrials.gov as NCT00945698.

Supplementation of Maternal Diets during Pregnancy and for 6 Months Postpartum and Infant Diets Thereafter with Small-Quantity Lipid-Based Nutrient Supplements Does Not Promote Child Growth by 18 Months of Age in Rural Malawi: A Randomized Controlled Trial.

BACKGROUND: Intrauterine growth restriction may be reduced by supplementing maternal diets during pregnancy, but few studies have assessed the impact of combined prenatal and postnatal interventions on child growth. OBJECTIVE: We tested a hypothesis that provision of small-quantity lipid-based nutrient supplements (SQ-LNSs) to mothers in pregnancy and 6 mo postpartum and to their infants from 6 to 18 mo of age would promote infant and child growth in the study area in rural Malawi. METHODS: We enrolled 869 pregnant women in a randomized trial in Malawi. During pregnancy and 6 mo thereafter, the women received daily 1 capsule of iron-folic acid (IFA), 1 capsule containing 18 micronutrients (MMN), or one 20-g sachet of SQ-LNS [lipid-based nutrient supplements (LNS), containing 21 MMN, protein, carbohydrates, essential fatty acids, and 118 kcal]. Children in the IFA and MMN groups received no supplementation; children in the LNS group received SQ-LNSs from 6 to 18 mo. Primary outcome was child length at 18 mo. RESULTS: At 18 mo, the mean length in the IFA, MMN, and LNS groups was 77.0, 76.9, and 76.8 cm (P = 0.90), respectively, and the prevalence of stunting was 32.7%, 35.6%, and 37.9% (P = 0.54), respectively. No intergroup differences were found in the mean weight, head circumference, or midupper arm circumference or the proportions with low z scores for these variables (P > 0.05). Covariate adjustment did not change the analysis results, and the associations between the intervention and child length were not modified by maternal parity, age, or nutritional status (P > 0.10). CONCLUSIONS: The findings do not support a hypothesis that provision of SQ-LNSs to women in pregnancy and postpartum and to children from 6 to 18 mo of age would promote child growth in this Malawian study area. This trial was registered at clinicaltrials.gov as NCT01239693.

Provision of 10-40 g/d Lipid-Based Nutrient Supplements from 6 to 18 Months of Age Does Not Prevent Linear Growth Faltering in Malawi.

BACKGROUND: Complementing infant diets with lipid-based nutrient supplements (LNSs) has been suggested to improve growth and reduce morbidity, but the daily quantity and the milk content of LNSs affect their cost. OBJECTIVE: We tested the hypotheses that the change in mean length-for-age z score (LAZ) for infants provided with 10-40 g LNSs/d from ages 6 to 18 mo would be greater than that for infants receiving no dietary intervention at the same age and that provision of LNSs that did not contain milk would be as good as milk-containing LNSs in promoting linear growth. METHODS: We enrolled in a randomized single-blind trial 6-mo-old infants who were allocated to 1 of 6 groups to receive 10, 20, or 40 g LNSs/d containing milk powder; 20 or 40 g milk-free LNSs/d; or no supplement until 18 mo of age. The primary outcome was change in LAZ. RESULTS: Of the 1932 enrolled infants, 78 (4.0%) died and 319 (16.5%) dropped out during the trial. The overall reported supplement consumption was 71.6% of days, with no difference between the groups (P = 0.26). The overall mean ± SD length and LAZ changes were 13.0 ± 2.1 cm and -0.45 ± 0.77 z score units, respectively, which did not differ between the groups (P = 0.66 for length and P = 0.74 for LAZ). The difference in mean LAZ change in the no-milk LNS group compared with the milk LNS group was -0.02 (95% CI: -0.10, 0.06; P = 0.72). CONCLUSION: Our results do not support the hypothesis that LNS supplementation during infancy and childhood promotes length gain or prevents stunting between 6 and 18 mo of age in Malawi. This trial was registered at clinicaltrials.gov as NCT00945698.

Association between maternal dental periapical infections and pregnancy outcomes: results from a cross-sectional study in Malawi.

OBJECTIVES: Maternal infections are associated with intrauterine growth restriction (IUGR) and preterm birth (PTB). Dental infections are common in low-income settings, but their contribution to adverse pregnancy outcomes is unknown. We studied the epidemiology of dental periapical infections among pregnant women and their association to foetal growth restriction and the duration of pregnancy in a rural sub-Saharan African population. METHODS: This was a cross-sectional study on the association between maternal dental periapical infections and birth outcomes, in Malawi, Africa. We assessed oral health clinically and radiologically among recently delivered women with known duration of pregnancy and measured birthweight (BW), length and head circumference of their infants. RESULTS: Of 1024 analysed participants, 23.5% had periapical infections. Mean duration of pregnancy was 39.4 weeks, BW 2979 g and length 49.7 cm. Women with periapical infection had mean (95% CI) pregnancy duration 0.4 weeks (0.1-0.8) shorter and delivered infants with 79 g (13-145) lower BW and 0.5 cm (0.2-0.9) shorter neonatal length than women without periapical infection. The incidence of PTB was 10.0% among women with periapical infection and 7.3% among those without (adjusted difference 3.5%, 95% CI -1.1-8.1%). Corresponding prevalences for stunting were 20.9% and 14.2% (adjusted difference 9.0%, 95% CI 2.7%-15.2%). The population-attributable risk fraction attributable to periapical infection was 9.7% for PTB and 12.8% for stunting. CONCLUSIONS: Periapical infection was associated with shorter pregnancy duration and IUGR in the study area; interventions addressing this risk factor may improve birth outcomes in low-income settings.

The impact of lipid-based nutrient supplement provision to pregnant women on newborn size in rural Malawi: a randomized controlled trial.

BACKGROUND: Small birth size, often associated with insufficient maternal nutrition, contributes to a large share of global child undernutrition, morbidity, and mortality. We developed a small-quantity lipid-based nutrient supplement (SQ-LNS) to enrich the diets of pregnant women. OBJECTIVE: The objective was to test a hypothesis that home fortification of pregnant women's diets with SQ-LNS would increase birth size in an African community. DESIGN: We enrolled 1391 women with uncomplicated pregnancies (<20 gestational weeks) in a randomized controlled trial in Malawi. The women were provided with one daily iron-folic acid (IFA) capsule, one capsule containing multiple micronutrients (MMNs), or one 20-g sachet of SQ-LNS (LNS, containing 118 kcal, protein, carbohydrates, essential fatty acids, and 21 micronutrients). Primary outcomes were birth weight and newborn length. Secondary outcomes included newborn weight, head and arm circumference, and pregnancy duration. Analysis was by intention to treat. RESULTS: The mean ± SD birth weight and newborn length were 2948 ± 432, 2964 ± 460, and 3000 ± 447 g (P = 0.258) and 49.5 ± 2.4, 49.7 ± 2.2, and 49.9 ± 2.1 cm (P = 0.104) in the IFA, MMN, and LNS groups, respectively. For newborn weight-for-age, head circumference, and arm circumference, the point estimate for the mean was also highest in the LNS group, intermediate in the MMN group, and lowest in the IFA group, but except for midupper arm circumference (P = 0.024), the differences were not statistically significant. The prevalence of low birth weight (<2500 g) was 12.7%, 13.5%, and 12.1% (P = 0.856), respectively; newborn stunting (length-for-age z score < -2) was 19.2%, 14.0%, and 14.9% (P = 0.130), respectively; and newborn small head circumference (head circumference-for-age z score < -2) was 5.8%, 3.0%, and 3.1% (P = 0.099), respectively. The associations between the intervention and the outcomes were not modified by maternal parity, age, or nutritional status (P > 0.100). CONCLUSION: The study findings do not support a hypothesis that provision of SQ-LNS to all pregnant women would increase the mean birth size in rural Malawi. The trial was registered at clinicaltrials.gov as NCT01239693.