TY - JOUR
T1 - Lipid-based nutrient supplements for maternal, birth, and infant developmental outcomes
AU - Das, Jai K.
AU - Hoodbhoy, Zahra
AU - Salam, Rehana A.
AU - Bhutta, Afsah Zulfiqar
AU - Valenzuela-Rubio, Nancy G.
AU - Weise Prinzo, Zita
AU - Bhutta, Zulfiqar A.
N1 - Funding Information:
Blinding of participants and personnel (performance bias) All outcomes Study duration: February 2011 to December 2015 Conflict of interest: one of the authors, Mamane Zeilani, works as a Drector of Research for Nutriset SAS, a company that produces and sells LNS supplements and also prepared the LNS supplements purchased for the current trial. The other authors declared no conflicts of interest related to this study Source of funding: supported, in part, by a grant from the Bill & Melinda Gates Foundation, with additional funding from the Office of Health, Infectious Diseases, and Nutrition, Bureau for Global Health, US Agency for International Development (USAID) under terms of Cooperative Agreement No. AID-OAA-A-12-00005, through the Food and Nutrition Technical Assistance III Project (FANTA), managed by FHI 360. For data management and statistical analysis, the team received additional support in grants from the Academy of Finland (grant 252075) and the Medical Research Fund of Tampere University Hospital (grant 9M004). The author Yin Bun Cheung was supported by the Singapore Ministry of Health’s National Medical Research Council under its Clinician Scientist Award. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript
Funding Information:
Study duration: March 2006 to June 2008 Conflict of interest: authors declared that none of the authors had any potential conflicts of interest Source of funding: Supported by Nutrition Third World, the Belgian Ministry of Development under agreement 96501, and the Flemish University Council under contract
Funding Information:
This study is funded by Strategic Impact Evaluation Fund (SIEF), the World Bank Innovation Grant, the Early Learning Partnership Grant, and the National Nutrition Office in Madagascar
Funding Information:
Quote: “Laboratory staff, anthropometrists, and data analysts had no knowledge of group assignment until all preliminary analyses had been completed” Comment: adequately done Comment: in IFA arm: 15/408 (3.7%) lost to follow-up; in MMN arm: 10/411 (2. 4%) lost to follow-up; in LNS arm: 18/409 (4.4%) lost to follow-up Comment: registered at ClinicalTrials.gov as NCT00970866. Statistical analysis plan was posted before (www.ilins.org) and all presented analyses were prespecified in the statistical analysis plan; adequately done Comment: no other sources of bias were identified. The study was funded by the Bill & Melinda Gates Foundation
Funding Information:
Comment: all presented analyses were prespecified either in the trial protocol or in the statistical analysis plan registered at Clinical.Trials.gov as NCT00909974 Comment: no other sources of bias were identified. The study was supported by the Flemish University Council, Nutrition Third World, and the Belgian Ministry of Development. The multiple micronutrient premix was donated by Nutriset, France
Funding Information:
Comment: overall 6.04% similar between groups; adequately done Comment: all presented analyses were prespecified either in the trial protocol or in the statistical analysis plan. Registered at clinicaltrials.gov as NCT01239693. Adequately done Comment: no other sources of bias were identified. The study was supported, in part, by a grant to the University of California, Davis, from the Bill & Melinda Gates Foundation, with additional funding from the Office of Health, Infectious Diseases, and Nutrition, Bureau for Global Health, US Agency for International Development (USAID)
Publisher Copyright:
© 2018 The Cochrane Collaboration.
PY - 2018/8/31
Y1 - 2018/8/31
N2 - Background: Ready-to-use lipid-based nutrient supplements (LNS) are a highly nutrient-dense supplement, which could be a good source of macro- and micronutrients for pregnant women who need to supplement their nutrient intake. Objectives: To assess the effects of LNS for maternal, birth and infant outcomes in pregnant women. Secondary objectives were to explore the most appropriate composition, frequency and duration of LNS administration. Search methods: In May 2018, we searched CENTRAL, MEDLINE, Embase, 22 other databases and two trials registers for any published and ongoing studies. We also checked the reference lists of included studies and relevant reviews, and we contacted the authors of included studies and other experts in the field to identify any studies we may have missed, including any unpublished studies. Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs that compared LNS given in pregnancy to no intervention, placebo, iron folic acid (IFA), multiple micronutrients (MMN) or nutritional counselling. Data collection and analysis: We used standard Cochrane procedures. Main results: We included four studies in 8018 pregnant women. All four studies took place in stable community settings in low- and middle-income countries: Bangladesh, Burkina Faso, Ghana and Malawi. None were in emergency settings. The oldest trial was published in 2009. Of the four included studies, one compared LNS to IFA, one compared LNS to MMN, and two compared LNS to both IFA and MMN. We considered the included studies to be of medium to high quality, and we rated the quality of the evidence as moderate using the GRADE approach. LNS versus IFA Maternal outcomes: there was no difference between the LNS and IFA groups as regards maternal gestational weight gain per week (standard mean difference (SMD) 0.46, 95% confidence interval (CI) -0.44 to 1.36; 2 studies, 3539 participants). One study (536 participants) showed a two-fold increase in the prevalence of maternal anaemia in the LNS group compared to the IFA group, but no difference between the groups as regards adverse effects. There was no difference between the two groups for maternal mortality (risk ratio (RR) 0.53, 95% CI 0.12 to 2.41; 3 studies, 5628 participants). Birth and infant outcomes: there was no difference between the LNS and IFA groups for low birth weight (LBW) (RR 0.87, 95% CI 0.72 to 1.05; 3 studies, 4826 participants), though newborns in the LNS group had a slightly higher mean birth weight (mean difference (MD) 53.28 g, 95% CI 28.22 to 78.33; 3 studies, 5077 participants) and birth length (cm) (MD 0.24 cm, 95% CI 0.11 to 0.36; 3 studies, 4986 participants). There was a reduction in the proportion of infants who were small for gestational age (SGA) (RR 0.94, 95% CI 0.89 to 0.99; 3 studies, 4823 participants) and had newborn stunting (RR 0.82, 95% CI 0.71 to 0.94; 2 studies, 4166 participants) in the LNS group, but no difference between the LNS and IFA groups for preterm delivery (RR 0.94, 95% CI 0.80 to 1.11; 4 studies, 4924 participants), stillbirth (RR 1.14; 95% CI 0.52 to 2.48; 3 studies, 5575 participants) or neonatal death (RR 0.96, 95% CI 0.14 to 6.51). The current evidence for child developmental outcomes is not sufficient to draw any firm conclusions. LNS versus MMN Maternal outcomes: one study (662 participants) showed no difference between the LNS and MMN groups as regards gestational weight gain per week or adverse effects. Another study (557 participants) showed an increased risk of maternal anaemia in the LNS group compared to the MMN group. Birth and infant outcomes: there was no difference between the LNS and MMN groups for LBW (RR 0.92, 95% CI 0.74 to 1.14; 3 studies, 2404 participants), birth weight (MD 23.67 g, 95% CI -10.53 to 57.86; 3 studies, 2573 participants), birth length (MD 0.20 cm, 95% CI -0.02 to 0.42; 3 studies, 2567 participants), SGA (RR 0.95, 95% CI 0.84 to 1.07; 3 studies, 2393 participants), preterm delivery (RR 1.15, 95% CI 0.93 to 1.42; 3 studies, 2630 participants), head circumference z score (MD 0.10, 95% CI -0.01 to 0.21; 2 studies, 1549 participants) or neonatal death (RR 0.88, 95% CI 0.36 to 2.15; 1 study, 1175 participants). Authors' conclusions: Findings from this review suggest that LNS supplementation has a slight, positive effect on weight at birth, length at birth, SGA and newborn stunting compared to IFA. LNS and MMN were comparable for all maternal, birth and infant outcomes. Both IFA and MMN were better at reducing maternal anaemia when compared to LNS. We did not find any trials for LNS given to pregnant women in emergency settings. Readers should interpret the beneficial findings of the review with caution since the evidence comes from a small number of trials, with one-large scale study (conducted in community settings in Bangladesh) driving most of the impact. In addition, effect sizes are too small to propose any concrete recommendation for practice.
AB - Background: Ready-to-use lipid-based nutrient supplements (LNS) are a highly nutrient-dense supplement, which could be a good source of macro- and micronutrients for pregnant women who need to supplement their nutrient intake. Objectives: To assess the effects of LNS for maternal, birth and infant outcomes in pregnant women. Secondary objectives were to explore the most appropriate composition, frequency and duration of LNS administration. Search methods: In May 2018, we searched CENTRAL, MEDLINE, Embase, 22 other databases and two trials registers for any published and ongoing studies. We also checked the reference lists of included studies and relevant reviews, and we contacted the authors of included studies and other experts in the field to identify any studies we may have missed, including any unpublished studies. Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs that compared LNS given in pregnancy to no intervention, placebo, iron folic acid (IFA), multiple micronutrients (MMN) or nutritional counselling. Data collection and analysis: We used standard Cochrane procedures. Main results: We included four studies in 8018 pregnant women. All four studies took place in stable community settings in low- and middle-income countries: Bangladesh, Burkina Faso, Ghana and Malawi. None were in emergency settings. The oldest trial was published in 2009. Of the four included studies, one compared LNS to IFA, one compared LNS to MMN, and two compared LNS to both IFA and MMN. We considered the included studies to be of medium to high quality, and we rated the quality of the evidence as moderate using the GRADE approach. LNS versus IFA Maternal outcomes: there was no difference between the LNS and IFA groups as regards maternal gestational weight gain per week (standard mean difference (SMD) 0.46, 95% confidence interval (CI) -0.44 to 1.36; 2 studies, 3539 participants). One study (536 participants) showed a two-fold increase in the prevalence of maternal anaemia in the LNS group compared to the IFA group, but no difference between the groups as regards adverse effects. There was no difference between the two groups for maternal mortality (risk ratio (RR) 0.53, 95% CI 0.12 to 2.41; 3 studies, 5628 participants). Birth and infant outcomes: there was no difference between the LNS and IFA groups for low birth weight (LBW) (RR 0.87, 95% CI 0.72 to 1.05; 3 studies, 4826 participants), though newborns in the LNS group had a slightly higher mean birth weight (mean difference (MD) 53.28 g, 95% CI 28.22 to 78.33; 3 studies, 5077 participants) and birth length (cm) (MD 0.24 cm, 95% CI 0.11 to 0.36; 3 studies, 4986 participants). There was a reduction in the proportion of infants who were small for gestational age (SGA) (RR 0.94, 95% CI 0.89 to 0.99; 3 studies, 4823 participants) and had newborn stunting (RR 0.82, 95% CI 0.71 to 0.94; 2 studies, 4166 participants) in the LNS group, but no difference between the LNS and IFA groups for preterm delivery (RR 0.94, 95% CI 0.80 to 1.11; 4 studies, 4924 participants), stillbirth (RR 1.14; 95% CI 0.52 to 2.48; 3 studies, 5575 participants) or neonatal death (RR 0.96, 95% CI 0.14 to 6.51). The current evidence for child developmental outcomes is not sufficient to draw any firm conclusions. LNS versus MMN Maternal outcomes: one study (662 participants) showed no difference between the LNS and MMN groups as regards gestational weight gain per week or adverse effects. Another study (557 participants) showed an increased risk of maternal anaemia in the LNS group compared to the MMN group. Birth and infant outcomes: there was no difference between the LNS and MMN groups for LBW (RR 0.92, 95% CI 0.74 to 1.14; 3 studies, 2404 participants), birth weight (MD 23.67 g, 95% CI -10.53 to 57.86; 3 studies, 2573 participants), birth length (MD 0.20 cm, 95% CI -0.02 to 0.42; 3 studies, 2567 participants), SGA (RR 0.95, 95% CI 0.84 to 1.07; 3 studies, 2393 participants), preterm delivery (RR 1.15, 95% CI 0.93 to 1.42; 3 studies, 2630 participants), head circumference z score (MD 0.10, 95% CI -0.01 to 0.21; 2 studies, 1549 participants) or neonatal death (RR 0.88, 95% CI 0.36 to 2.15; 1 study, 1175 participants). Authors' conclusions: Findings from this review suggest that LNS supplementation has a slight, positive effect on weight at birth, length at birth, SGA and newborn stunting compared to IFA. LNS and MMN were comparable for all maternal, birth and infant outcomes. Both IFA and MMN were better at reducing maternal anaemia when compared to LNS. We did not find any trials for LNS given to pregnant women in emergency settings. Readers should interpret the beneficial findings of the review with caution since the evidence comes from a small number of trials, with one-large scale study (conducted in community settings in Bangladesh) driving most of the impact. In addition, effect sizes are too small to propose any concrete recommendation for practice.
UR - http://www.scopus.com/inward/record.url?scp=85052621966&partnerID=8YFLogxK
U2 - 10.1002/14651858.CD012610.pub2
DO - 10.1002/14651858.CD012610.pub2
M3 - Review article
C2 - 30168868
AN - SCOPUS:85052621966
SN - 1361-6137
VL - 2018
JO - Cochrane Database of Systematic Reviews
JF - Cochrane Database of Systematic Reviews
IS - 8
M1 - CD012610
ER -