Primary health care in rural Malawi - a qualitative assessment exploring the relevance of the community-directed interventions approach

BACKGROUND: Primary Health Care (PHC) is a strategy endorsed for attaining equitable access to basic health care including treatment and prevention of endemic diseases. Thirty four years later, its implementation remains sub-optimal in most Sub-Saharan African countries that access to health interventions is still a major challenge for a large proportion of the rural population. Community-directed treatment with ivermectin (CDTi) and community-directed interventions (CDI) are participatory approaches to strengthen health care at community level. Both approaches are based on values and principles associated with PHC. The CDI approach has successfully been used to improve the delivery of interventions in areas that have previously used CDTi. However, little is known about the added value of community participation in areas without prior experience with CDTi. This study aimed at assessing PHC in two rural Malawian districts without CDTi experience with a view to explore the relevance of the CDI approach. We examined health service providers’ and beneficiaries’ perceptions on existing PHC practices, and their perspectives on official priorities and strategies to strengthen PHC. METHODS: We conducted 27 key informant interviews with health officials and partners at national, district and health centre levels; 32 focus group discussions with community members and in-depth interviews with 32 community members and 32 community leaders. Additionally, official PHC related documents were reviewed. RESULTS: The findings show that there is a functional PHC system in place in the two study districts, though its implementation is faced with various challenges related to accessibility of services and shortage of resources. Health service providers and consumers shared perceptions on the importance of intensifying community participation to strengthen PHC, particularly within the areas of provision of insecticide treated bed nets, home case management for malaria, management of diarrhoeal diseases, treatment of schistosomiasis and provision of food supplements against malnutrition. CONCLUSION: Our study indicates that intensified community participation based on the CDI approach can be considered as a realistic means to increase accessibility of certain vital interventions at community level

Diagnosis of Newly Delivered Mothers for Periodontitis with a Novel Oral-Rinse aMMP-8 Point-of-Care Test in a Rural Malawian Population

A novel qualitative point-of-care test of activated matrix metalloproteinase-8 (aMMP-8) using noninvasive oral rinse sampling procedures has been developed for the early detection of collagen breakdown indicating periodontal tissue destruction. The main object of this study was to assess the reliability of the test in a low-income setting to identify participants with history of periodontal destruction detected as alveolar bone loss (ABL) in radiographs. This cross-sectional study included 486 women who had recently delivered in rural Malawi. The aMMP-8 test and dental panoramic radiographs were taken within 48 h of delivery. The performance of the test in comparison to radiological examinations was tested by following the standards for reporting of diagnostic accuracy studies protocol (STARD) with respective statistical measures and 95% confidence intervals. From the 486 eligible participants, 461 mothers with complete data, aged from 15 to 46 years (mean 24.8, SD 6.0) were included in the analysis. ABL was identified in 116 of 461 participants. There was 56% agreement between the aMMP-8 test results and detected ABL (yes or no) in radiographs. Calculated sensitivity of the test was 80% (72–87%), specificity 48% (43–54%), positive predictive value 34% (31–37%), negative predictive value 88% (83–91%), positive likelihood ratio 1.55 (1.35–1.77), and negative likelihood ratio 0.41(0.28–0.60). The aMMP-8 test sensitivity and negative predictive value to identify the ABL cases were relatively high, but there was additionally a high rate of test-positive results in participants without ABL, especially in young mothers, leading to low overall agreement between the test results and radiological bone loss. Further longitudinal studies are needed to examine if the test positive subjects are in risk of future bone loss before the detectable signs of periodontitis in radiographs.Peer reviewe

Levels of knowledge regarding malaria causes, symptoms, and prevention measures among Malawian women of reproductive age

Background: Malawi is a malaria-endemic country and approximately 6 million cases are reported annually. Improving knowledge of malaria causes and symptoms, and the overall perception towards malaria and its preventive measures is vital for malaria control. The current study investigated the levels of knowledge of the causes, symptoms and prevention of malaria among Malawian women. Methods: Data from the 2017 wave of the Malawi Malaria Indicator Survey (MMIS) were analysed. In total, 3422 women of reproductive age (15–49 years) were sampled and analysed. The levels of women’s knowledge about: (1) causes of malaria; (2) symptoms of malaria; and, (3) preventive measures were assessed. The tertiles of the composite score were used as the cut-offs to categorize the levels of knowledge as ‘low’, ‘medium’ and ‘high’. Multinomial logistic regression models were constructed to assess the independent factors while taking into account the complex survey design. Results: Approximately 50% of all respondents had high levels of knowledge of causes, symptoms and preventive measures. The high level of knowledge was 45% for rural women and 55% for urban dwellers. After adjusting for the a wide range of factors, women of age group 15–19 years adjusted odds ratio ((aOR): 2.58; 95% Confidence Interval (CI) 1.69–3.92), women with no formal education (aOR: 3.73; 95% CI 2.20–6.33), women whose household had no television (aOR: 1.50; 95% CI 1.02–2.22), women who had not seen/heard malaria message (aOR: 1.53; 95% CI 1.20–1.95), women of Yao tribe (aOR: 1.95; 95% CI 1.10–3.46), and women from rural areas had low levels of knowledge about the causes of malaria, symptoms of malaria and preventive measures. Additionally, the results also showed that women aged 15–19 years (beta [β] = − 0.73, standard error [SE] = 0.12); P < .0001, women with no formal education (β = − 1.17, SE = 0.15); P < .0001, women whose household had no radio (β = − 0.15, SE = 0.0816); P = 0.0715 and women who had not seen or heard malaria message (β = − 0.41, SE = 0.07); P < .0001 were likely to have a lower knowledge score. Conclusions: The levels of malaria knowledge were reported to be unsatisfactory among adult women, underscoring the need to scale up efforts on malaria education. Beside insecticide-treated bed nets (ITNs) and prompt diagnosis, malaria can be best managed in Malawi by increasing knowledge of malaria causes, and symptoms especially for younger women, women with no formal education, women whose households have no media, women from Yao tribes, and rural dwellers

Human Protoparvovirus DNA and IgG in Children and Adults with and without Respiratory or Gastrointestinal Infections

Abstract: Three human protoparvoviruses, bufavirus (BuV), tusavirus (TuV) and cutavirus (CuV), have recently been discovered in diarrheal stool. BuV has been associated with diarrhea and CuV with cutaneous T-cell lymphoma, but there are hardly any data for TuV or CuV in stool or respiratory samples. Hence, using qPCR and IgG enzyme immunoassays, we analyzed 1072 stool, 316 respiratory and 445 serum or plasma samples from 1098 patients with and without gastroenteritis (GE) or respiratory-tract infections (RTI) from Finland, Latvia and Malawi. The overall CuV-DNA prevalences in stool samples ranged between 0–6.1% among our six patient cohorts. In Finland, CuV DNA was significantly more prevalent in GE patients above rather than below 60 years of age (5.1% vs 0.2%). CuV DNA was more prevalent in stools among Latvian and Malawian children compared with Finnish children. In 10/11 CuV DNA-positive adults and 4/6 CuV DNA-positive children with GE, no known causal pathogens were detected. Interestingly, for the first time, CuV DNA was observed in two nasopharyngeal aspirates from children with RTI and the rare TuV in diarrheal stools of two adults. Our results provide new insights on the occurrence of human protoparvoviruses in GE and RTI in different countries.Peer reviewe

The Impact of Antenatal Azithromycin and Monthly Sulfadoxine-Pyrimethamine on Maternal Malaria during Pregnancy and Fetal Growth : A Randomized Controlled Trial

Maternal malaria and infections during pregnancy are risk factors for fetal growth restriction. We assessed the impact of preventive treatment in pregnancy on maternal malaria and fetal growth. Between 2003 and 2006, we enrolled 1,320 pregnant Malawian women, 14-26 gestation weeks, in a randomized trial and treated them with two doses of sulfadoxine-pyrimethamine (SP, control) at enrollment and between 28-34 gestation weeks; with monthly SP from enrollment until 37 gestation weeks; or with monthly SP and azithromycin twice, at enrollment and between 28 and 34 gestation weeks (AZI-SP). Participants were seen at 4-week intervals until 36 completed gestation weeks and weekly thereafter. At each visit, we collected dried blood spots for real-time polymerase chain reaction diagnosing of malaria parasitemia and, in a random subgroup of 341 women, we measured fetal biparietal diameter and femur length with ultrasound. For the monthly SP versus the control group, the odds ratios (OR) (95% CI) of malaria parasitemia during the second, third, and both trimesters combined were 0.79 (0.46-1.37), 0.58 (0.37-0.92), and 0.64 (0.42-0.98), respectively. The corresponding ORs for the AZI-SP versus control group were 0.47 (0.26-0.84), 0.51 (0.32-0.81), and 0.50 (0.32-0.76), respectively. Differences between the AZI-SP and the monthly SP groups were not statistically significant. The interventions did not affect fetal biparietal diameter and femur length growth velocity. The results suggest that preventive maternal treatment with monthly SP reduced malaria parasitemia during pregnancy in Malawi and that the addition of azithromycin did not provide much additional antimalarial effect.publishedVersionPeer reviewe

Human Protoparvovirus DNA and IgG in Children and Adults with and without Respiratory or Gastrointestinal Infections

Abstract: Three human protoparvoviruses, bufavirus (BuV), tusavirus (TuV) and cutavirus (CuV), have recently been discovered in diarrheal stool. BuV has been associated with diarrhea and CuV with cutaneous T-cell lymphoma, but there are hardly any data for TuV or CuV in stool or respiratory samples. Hence, using qPCR and IgG enzyme immunoassays, we analyzed 1072 stool, 316 respiratory and 445 serum or plasma samples from 1098 patients with and without gastroenteritis (GE) or respiratory-tract infections (RTI) from Finland, Latvia and Malawi. The overall CuV-DNA prevalences in stool samples ranged between 0–6.1% among our six patient cohorts. In Finland, CuV DNA was significantly more prevalent in GE patients above rather than below 60 years of age (5.1% vs 0.2%). CuV DNA was more prevalent in stools among Latvian and Malawian children compared with Finnish children. In 10/11 CuV DNA-positive adults and 4/6 CuV DNA-positive children with GE, no known causal pathogens were detected. Interestingly, for the first time, CuV DNA was observed in two nasopharyngeal aspirates from children with RTI and the rare TuV in diarrheal stools of two adults. Our results provide new insights on the occurrence of human protoparvoviruses in GE and RTI in different countries.Peer reviewe

Posture-Related Differences in Cardiovascular Function Between Young Men and Women : Study of Noninvasive Hemodynamics in Rural Malawi

Background Cardiovascular risk is higher in men than in women, but little information exists about sex-related differences in cardiovascular function from low-income countries. We compared hemodynamics between sexes in rural Malawi in a cohort followed up since their birth. Methods and Results Supine, seated, and standing hemodynamics were recorded from 251 women and 168 men (mean age, 21 years; body mass index, 21 kg/m2) using oscillometric brachial waveform analyses (Mobil-O-Graph). The results were adjusted for estimated glomerular filtration rate, and plasma potassium, lipids, and glucose. Men had higher brachial and aortic systolic blood pressure and stroke index regardless of posture (P<0.001), and higher upright but similar supine diastolic blood pressure than women. Regardless of posture, heart rate was lower in men (P<0.001), whereas cardiac index did not differ between sexes. Women presented with lower supine and standing systemic vascular resistance index (P<0.001), whereas supine-to-standing increase in vascular resistance (P=0.012) and decrease in cardiac index (P=0.010) were higher in women. Supine left cardiac work index was similar in both sexes, whereas standing and seated left cardiac work index was higher in men than in women (P<0.001). Conclusions In young Malawian adults, men had higher systolic blood pressure, systemic vascular resistance, and upright cardiac workload, whereas women presented with higher posture-related changes in systemic vascular resistance and cardiac output. These findings show systematic sex-related differences in cardiovascular function in a cohort from a low-income country with high exposure to prenatal and postnatal malnutrition and infectious diseases.publishedVersionPeer reviewe

Human Protoparvovirus DNA and IgG in Children and Adults with and without Respiratory or Gastrointestinal Infections

Three human protoparvoviruses, bufavirus (BuV), tusavirus (TuV) and cutavirus (CuV), have recently been discovered in diarrheal stool. BuV has been associated with diarrhea and CuV with cutaneous T-cell lymphoma, but there are hardly any data for TuV or CuV in stool or respiratory samples. Hence, using qPCR and IgG enzyme immunoassays, we analyzed 1072 stool, 316 respiratory and 445 serum or plasma samples from 1098 patients with and without gastroenteritis (GE) or respiratory-tract infections (RTI) from Finland, Latvia and Malawi. The overall CuV-DNA prevalences in stool samples ranged between 0-6.1% among our six patient cohorts. In Finland, CuV DNA was significantly more prevalent in GE patients above rather than below 60 years of age (5.1% vs 0.2%). CuV DNA was more prevalent in stools among Latvian and Malawian children compared with Finnish children. In 10/11 CuV DNA-positive adults and 4/6 CuV DNA-positive children with GE, no known causal pathogens were detected. Interestingly, for the first time, CuV DNA was observed in two nasopharyngeal aspirates from children with RTI and the rare TuV in diarrheal stools of two adults. Our results provide new insights on the occurrence of human protoparvoviruses in GE and RTI in different countries

Maaseudun malawilaislasten terveen kasvun edistäminen rasvapohjaisilla lisäravinteilla

Maaseudun malawilaislasten terveen kasvun edistäminen rasvapohjaisilla lisäravinteilla Lasten lyhytkasvuisuus (ikään suhteutetun pituuden z-arvo <-2,00) on edelleen maailmanlaajuisesti merkittävä terveysongelma, joka koskettaa miljoonia lapsia. Noin joka kolmas alhaisen ja keskitulotason maissa elävistä alle 5-vuotiaista lapsista arvioidaan lyhytkasvuiseksi. Heikentynyt kehitys on myös yleistä, ja onkin arvioitu, että 200 miljoonaa näistä lapsista ei koskaan saavuta kehityspotentiaaliaan. Lyhytkasvuisuutta ilmenee yleensä 6–24 kuukauden iässä. Se lisää sairastuvuutta ja kuolleisuutta ja on riskitekijä kehityksen viivästymiselle ja kehityshäiriöille. Se vaikuttaa lisäksi aikuisiän terveyteen ja tuotteliaisuuteen. Lyhytkasvuisuus liitetään alhaisen ja keskitulotason maissa elävien lasten huonoon täydentävän ravinnon saantiin. Yritykset puuttua tilanteeseen ovat toistaiseksi saavuttaneet vaatimatonta menestystä pituuskasvun edistämisessä ja lyhytkasvuisuuden ehkäisemisessä. Rasvapohjaiset lisäravinteet on viime aikoina nostettu esiin mahdollisena edullisena strategiana, jolla voitaisiin rikastaa paikallista täydentävää ravintoa. Niitä on käytetty onnistuneesti akuutista aliravitsemuksesta kärsivien lasten hoitamisessa. Myöhemmistä tutkimuksista saadut näytöt näyttäisivät osoittavan, että jotkut versiot rasvapohjaisista lisäravinteista voisivat edistää tervettä kasvua ja ehkäistä aliravitsemuksen kehittymistä. Näytöt tästä ovat kuitenkin vaatimattomia ja vaativat lisäkehittämistä. Suurimmassa osassa tutkimuksista pääpainopiste on lisäksi ollut antropometrisiin mittauksiin (kuten pituus ja paino) tai hivenaineisiin (pääasiassa rauta, hemoglobiinipitoisuus) liittyvissä tuloksissa. Vain muutama tutkimus on arvioinut, miten rasvapohjaisten lisäravinteiden hyödyntäminen täydentävässä ruokavaliossa vaikuttaa lapsen kehitykseen tai sairastavuuteen. Rasvapohjaisten lisäravinteiden yleisen käytön turvallisuutta malaria-alueilla (niiden sisältämä lisärauta huomioon ottaen) ei myöskään ole juurikaan arvioitu. Elimistön liiallisen raudan on ehdotettu lisäävän tartunnan riskiä malariaparasiiteistä sekä patogeenisten suolistobakteerien kasvua, mikä johtaa lisääntyneeseen malarian sairastamiseen ja muihin infektioihin. Tutkimuksen ensimmäinen tavoite oli tutkia rasvapohjaisten lisäravinteiden vaikutuksia imeväisten ja pienten lasten lyhytkasvuisuuden ehkäisemiseen ja kasvun edistämiseen voitiin arvioida. Tutkimuksen toisena tavoitteena oli arvioida lisäravinteiden vaikutusta lasten kehityksen virstanpylväiden saavuttamiseen. Kolmantena tavoitteena oli arvioida rasvapohjaisten lisäravinnetuotteiden turvallisuutta sen perusteella, johtaako niiden käyttö sairastuvuuden lisääntymiseen verrattuna ruokavalioihin, josta ne puuttuvat, ja mikäli lisääntynyttä sairastuvuutta ei todettaisi, tavoitteena oli arvioida lisäravinteiden vaikutusta sairastuvuuden vähentämiseen. Näiden tavoitteiden arvioimiseksi suoritettiin satunnaistettu, yhteisöllinen kliininen tutkimus Malawin maaseudulla. Tutkimukseen osallistui yhteensä 840 kuuden kuukauden ikäistä lasta, joiden ruokavaliota täydennettiin 12 kuukauden ajan joko rasvapohjaisilla lisäravinteilla, joihin oli lisätty maitoa (maitoryhmä), rasvapohjaisilla lisäravinteilla, joihin oli lisätty soijaa (soijaryhmä), maissi-soijaseoksella tai ruokavaliota ei täydennetty lainkaan (kontrolliryhmä). Lasten sairastuvuutta ja kasvutavoitteita seurattiin kotioloissa kahden viikon välein. Kasvutavoitteita, hemoglobiinipitoisuutta, parasiittien määrää veressä ja lasten kehitystä arvioitiin tutkimustoimistossa aina 12 viikon välein. 12 kuukauden seurantajakson päättyessä lopulliset kasvumittaukset saatiin 747 osallistujalta (88,9 %). Interventioryhmien välillä ei ollut merkittäviä eroja seurannan onnistumisen suhteen (P = 0,852). Merkittävän lyhytkasvuisuuden esiintyvyys seurantajakson aikana oli 11,8 % kontrolliryhmässä, 8,2 % maitoryhmässä, 9,1 % soijaryhmässä ja 15,5 % maissi-soijaseosryhmässä (p=0,098), kun taas erittäin merkittävän lyhytkasvuisuuden esiintyvyydet olivat 7,4 %, 2,9 %, 8,0 % ja 6,4 % (p=0,138). Interventiojakson lopussa merkittävästi lyhytkasvuisten lasten osuudet samoissa ryhmissä olivat 14,1 %, 11,0 %, 16,0 % ja 16,1 % (p=0,454). Keskimääräinen pituuden kasvu oli 13,0 cm kontrolliryhmässä, 13,2 cm maitoryhmässä, 13,0 cm soijaryhmässä ja 12,9 cm maissi-soijaseosryhmässä (p=0,43), kun taas keskimääräiset painon kasvut olivat 2,42 kg, 2,53 kg, 2,46 kg ja 2,32 kg (p=0,12). Keskimääräinen muutos lasten pituudessa ikään suhteutettuna oli -0,15 kontrolliryhmässä, -0,02 maitoryhmässä, -0,12 soijaryhmässä ja -0,18 maissi-soijaseosryhmässä (P = 0,045) ikäkuukausien 9 ja 12 välillä. Ryhmien välillä ei kuitenkaan ollut merkittäviä eroja pituuskasvussa muiden ikäkuukausien välillä. Lasten kehityksen virstanpylväiden saavuttamiseen liittyvistä luvuista keskimääräinen ikä, jolloin lapset oppivat kävelemään avustettuna, oli 42,5 viikkoa kontrolliryhmässä, 42,3 maitoryhmässä, 42,7 soijaryhmässä ja 43,2 maissi-soijaseosryhmässä (p=0,75). Näissä ryhmissä ei myöskään havaittu merkittäviä eroja keskimääräisessä iässä, jolloin lapset oppivat seisomaan omin avuin (45,0, 44,9, 45,1 ja 46,3 viikkoa), kävelemään omin avuin (54,6, 55,1, 55,3, 56,5 viikkoa) tai juoksemaan (64,6, 63,7, 64,8, 65,9 viikkoa). Sairastavuuteen liittyvistä luvuista kuumesairaana vietettyjen päivien osuus ikäkuukausien 6–18 välillä oli 4,9 % eikä ryhmien välillä ollut eroja: 4,9 % (95 % luottamusväli 4,3, 5,5 %) maitoryhmässä, 4,5% (3,9, 5,1 %) soijaryhmässä, 4,7 % (4,1, 5,3 %) maissi-soijaseosryhmässä ja 5,5 % (4,7–6,3 %) kontrolliryhmässä. Ryhmien välillä ei myöskään ollut eroja sellaisten päivien osuudessa, jolloin lapsella oli hengitysvaikeuksia tai ripulia ikäkuukausien 6-18 välillä. Interventioryhmillä ja kontrolliryhmällä oli 12 kuukauden seurantajakson aikana samantasoinen riski sairastua kliiniseen malariaan ja 95 % luottamusväli todistaa, ettei testattavilla tuotteilla ole huonompi vaikutus kuin jo käytössä olevilla keinoilla (ilmaantuvuussuhde [95 % luottamusväli] maitoryhmässä = 0,80 (0,59, 1,09); soijaryhmässä = 0,77 (0,56, 1,06); ja maissi-soijaseosryhmässä = 0,79 (0,58, 1,08)). Kuumejaksojen, hengitysvaikeuksien ja sairaalakäyntien ilmaantuvuus sekä malariaparasiittien yleisyys veressä olivat kaikissa ryhmissä samaa tasoa koko seurantajakson ajan. Molemmissa rasvapohjaisia lisäravinteita käyttäneissä ryhmissä havaittiin merkitykseltään vähäistä lisääntymistä ripulin ilmaantuvuudessa kontrolliryhmään verrattuna. Yhteenvetona voidaan todeta, että vuoden kestänyt rasvapohjaisten lisäravinteiden käyttö ei yleisesti ehkäissyt lyhytkasvuisuuden ilmaantuvuutta tai johtanut kasvun edistämiseen verrattuna maissi-soijaseoksen nauttimiseen tai ruokavalioon ilman lisäravinteita. Tutkimuksen tulokset viittaavat kuitenkin siihen, että rasvapohjaisten lisäravinteiden nauttiminen maitoon lisättynä voi hidastaa lapsen kasvun hidastumista ikäkuukausien 9 ja 12 välillä. Tämä ikäkausi vastaa aikaa, jolloin lapsen normaali kasvu etenee imeväisiästä lapsuuteen imeväisikä-lapsuus-murrosikä kasvumallin mukaisesti. Rasvapohjaisten lisäravinteiden tai maissi-soijaseoksen nauttiminen ei vaikuttanut valittujen kehityksen virstanpylväiden saavuttamiseen ja vaikutukset lapsen kehitykseen olivat samanlaisia lisäravinteita sisältävän ja sisältämättömän ruokavalion välillä. Ruokavalion täydentäminen rasvapohjaisilla lisäravinteilla tai maissi-soijaseoksella ei lisännyt malarian tai hengitysvaikeuksien sairastamisen ilmaantuvuutta. Rasvapohjaisten lisäravinteiden nauttiminen yhdistettiin kuitenkin vähäiseen ripulin ilmaantuvuuden lisääntymiseen, joskaan tutkimustulosten perusteella ei voida päätellä, onko rasvapohjaisilla lisäravinteilla huonompi vaikutus kuin ruokavaliolla ilman lisäravinteita. Tässä tutkimuksessa saatuja etelämalawilaisia lapsia koskevia tuloksia voidaan käyttää sellaisten rasvapohjaisia lisäravinteita hyödyntävien ohjelmien suunnitteluun, joilla pyritään ehkäisemään aliravitsemusta ja edistämään normaalia pituuskasvua sekä lasten varhaista kasvua samankaltaisissa olosuhteissa. Tällaisten ohjelmien tulee kuitenkin arvioida, olisiko hyödyllistä yhdistää lisäravinteisiin muita interventiostrategioita, kuten sellaisia, jotka pyrkivät parantamaan vedenlaatua, yleistä puhtaanapitoa ja hygieniaa tai ehkäisemään ja hallitsemaan infektioita subkliiniset infektiot mukaan lukien.Childhood stunting (length-for-age z-score of <-2.00) remains a global health priority affecting millions of children. About a third of all children younger than 5 years in low-income and middle-income countries (LMICs) are estimated to be stunted. Impaired development is common too, with an estimated 200 million of these children failing to attain their developmental potential. Stunting commonly occurs between the ages of 6 to 24 months, contributes to increased morbidity and mortality and is a risk factor for developmental delay or deficits. It also affects health and productivity in adulthood. Stunting is associated with poor complementary feeding in children living in LMICs. Interventions addressing this have so far had modest success in promotion of linear growth and its prevention. Recently, lipid-based nutrient supplements (LNS) have emerged as a potential low-cost strategy for enrichment of local complementary foods. They have been used successfully in treatment of children with severe acute malnutrition. Evidence from subsequent studies seems to indicate that some versions of LNS products might promote healthy growth and also prevent the development of undernutrition. Nevertheless, evidence of this is modest and still developing. Furthermore, in most of these studies, the focus has been on outcomes related to anthropometric measurements (such as height, weight) or micronutrient status (mainly iron, hemoglobin concentration). Only a few of the studies have also evaluated the effect of supplementation of complementary diet with LNS on child development, or on morbidity. In addition, the safety of universal use of LNS products in malaria-endemic areas (in view of their iron-fortification) has scarcely been assessed. Excess iron availability in the body has been suggested to facilitate infection from malaria parasites, and growth of pathogenic intestinal bacteria, leading to increased morbidity from malaria and other infections. The present study was therefore conducted first, to evaluate the effects of supplementation with LNS on the prevention of stunting, and promotion of growth among infants and young children. The second aim was to assess the effect of the supplementation on the achievement of developmental milestones. The third aim was to assess the safety of LNS products by evaluating if supplementation leads to more frequent morbidity compared to no supplementation, and in the absence of excess morbidity, to evaluate effect of LNS on morbidity reduction. To evaluate these aims, a randomized community-based clinical trial was conducted in rural Malawi. A total of 840 6-month-old infants were enrolled and allocated to receive supplementation with either Milk-LNS, Soy-LNS, corn-soy blend (CSB) or no nutritional supplementation (control) for 12 months. Children were followed every 2-weeks at home on morbidity, and developmental outcomes. At every 12-weeks interval from enrolment, outcomes on growth, haemoglobin concentration, malaria parasitemia and development were assessed at trial office. At the end of 12-month follow-up period, final growth measurements were obtained from 747 of the participants (88.9%). There was no significant differences between intervention groups on their success to follow-up (P = 0.852). The incidence of severe stunting was 11.8%, 8.2%, 9.1%, and 15.5% (p=0.098) and that of very severe stunting 7.4%, 2.9%, 8.0%, and 6.4% (p=0.138) in control, Milk-LNS, Soy-LNS, or CSB respectively during the follow-up period. In the same groups, the proportion of children who were severely stunted at the end of the intervention period was 14.1%, 11.0%, 16.0%, and 16.1% (p=0.454) .Mean length and weight gains were 13.0 cm, 13.2 cm, 13.0 cm and 12.9 cm (p=0.43) and 2.42 kg, 2.53 kg, 2.46 kg and 2.32 kg (p=0.12) in control, Milk-LNS, Soy-LNS, or CSB respectively. Between 9 and 12 months of age, the mean change in length-for-age was -0.15 in control, -0.02 in milk–LNS, -0.12 in soy–LNS and -0.18 (P = 0.045) in CSB group. There were however no significant differences between the groups in linear growth during the other age-intervals. Related to the achievement of developmental milestones, the mean age at achievement of walking with assistance was 42.5, 42.3, 42.7, and 43.2 weeks in control, milk-LNS, soy-LNS and CSB, respectively (p=0.75). Similarly, in the same groups, no significant differences were observed in either the mean age at standing alone (45.0, 44.9, 45.1, and 46.3 weeks), walking alone (54.6, 55.1, 55.3, 56.5 weeks), or running (64.6, 63.7, 64.8, 65.9 weeks). Regarding morbidity, the proportion of days with febrile illness between 6 and 18 months was 4.9% and there were no differences between the groups: 4.9% (95% CI 4.3, 5.5%), 4.5% (3.9, 5.1%), 4.7% (4.1, 5.3%), 5.5% (4.7-6.3%) in milk-LNS, soy-LNS, CSB and control, respectively. The proportion of days with respiratory problems and diarrhea between 6 and 18 months of age did not also differ between groups. The risk of clinical malaria was similar between the intervention groups and the control group over the 12 months follow-up period with 95% confidence intervals confirming non-inferiority (incident rate ratio [95%CI] for milk-LNS=0.80 (0.59, 1.09); 0.77 (0.56, 1.06) for soy-LNS; and 0.79 (0.58, 1.08) for CSB). Incidence of febrile episodes, respiratory problems or admission to hospital, prevalence of malaria parasitemia throughout the follow-up were also similar between the groups. There was non-significant increase in diarrhea incidence in the two LNS groups compared to the control group. In conclusion, a year-long supplementation with LNS did not generally prevent incidence of stunting or result in growth promotion compared to CSB or no supplementation. However, the study findings suggest that supplementation with milk-LNS may slow down the process of infant growth faltering at the ages of 9-to-12 months. This period corresponds with the time when the normal growth of a child, as described by the infancy-childhood-puberty model, transition from the infancy phase into the childhood phase of growth. Secondly, provision of LNS or CSB did not have an impact on the achievement of the selected developmental milestones with similar effect between the supplements and no supplementation on child development. Lastly, supplementation with LNS or CSB did not result in increases in malaria or respiratory morbidity. However, LNS supplementation was associated with modest increase in diarrhea incidence though the findings could not conclude non-inferiority of the LNS products in comparison to no supplementation. The findings from the present study obtained from southern Malawi could be used for designing of programmes using LNS products that aim at prevention of undernutrition, and promotion of normal linear growth and early child development in similar settings. Such programmes however need to evaluate the benefits of incorporating other intervention strategies such as those that aim to improve water quality, general sanitation and hygiene, or prevent and control infections including subclinical conditions