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      Micronutrient Supplementation for Pregnant and Lactating Women to Improve Maternal and Infant Nutritional Status in Low- and Middle-Income Countries: Protocol for a Systematic Review and Meta-analysis

      , MA, MPA, PhD 1 , , , PhD 1 , , PhD 2 , , MD, MPH 2 , , PhD 3 , , MD, MPH, PhD 1
      (Reviewer), (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      antenatal care, multiple micronutrient supplementation, pregnant and lactating women, systematic review and meta-analysis, review, meta-analysis, meta-analyses, low- and middle-income countries, LMIC, low income, middle income, women's health, pregnant, pregnancy, natal, maternal, maternity, infant, baby, babies, lactation, lactating, breastfeed, nutrition, vitamin, nutrient, supplement

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          Two billion people in low- and middle-income countries (LMICs) are deficient in key nutrients. Nutritional deficiencies worsen during pregnancy, causing adverse outcomes for the mother and the fetus, with consequences after pregnancy. These effects may be mitigated by providing micronutrient supplementation to women during pregnancy and lactation. However, the effects of micronutrient supplementation on the nutritional status of pregnant and lactating women and that of their infants remain largely unclear in LMICs. 


          The purpose of this systematic review and meta-analysis is to determine the effects of single, double, or multiple micronutrient supplements during pregnancy or lactation on maternal and infant nutritional status in LMICs.


          Randomized controlled trials of single, double, or combinations of micronutrients assessing effects on the maternal (serum, plasma, and breastmilk) and infant (serum and plasma) nutritional status will be included. MEDLINE (through PubMed), EMBASE, CENTRAL (through Cochrane Library), and the World Health Organization (WHO) library database will be used to identify relevant published studies, starting from the inception of each database until February 28, 2022. The Cochrane Risk of Bias Tool will be used to assess the risk of bias in the included studies. The selection of studies, data extraction, and risk of bias assessment will be carried out independently by 2 reviewers. A narrative summary will be provided of all the included studies. Meta-analyses will be performed whenever possible, and the heterogeneity of effects will be evaluated using I 2, subgroup analyses, and metaregression. The certainty of the evidence for each outcome will be assessed using the GRADE (Grading of Recommendation, Assessment, Development, and Evaluation) approach.


          We will conduct meta-analyses using Stata software (version 16, StataCorp) and present both a narrative and systematic summary of all studies included in this review in text and table form. For continuous outcomes, effect estimates will be expressed as mean differences and standardized mean differences, while for binary outcomes, they will be expressed as risk ratios, rate ratios, hazards ratios, or odds ratios, all with 95% CIs and comparing the intervention group with the control group. When studies for an outcome are adequately consistent with respect to intervention, comparator, and definition of the outcome, a random-effects, inverse variance-weighted meta-analysis will be conducted. We will provide a narrative synthesis for outcomes with insufficient data or extreme heterogeneity.


          This review will provide evidence upon which to base policy and programming for women in LMICs to supplement micronutrients in pregnancy and lactation. Detailed results disaggregated by variables such as maternal age, sex of infant, duration, and dose of intervention may also help policy makers, researchers, practitioners, and government agencies to adopt more effective maternal and child health policies and programs in LMICs. The review will also identify any gaps in the existing evidence.

          Trial Registration

          PROSPERO CRD42022308715; https://tinyurl.com/y33cxekr.

          International Registered Report Identifier (IRRID)


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          Most cited references41

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          Bias in meta-analysis detected by a simple, graphical test

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            Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement

            Systematic reviews should build on a protocol that describes the rationale, hypothesis, and planned methods of the review; few reviews report whether a protocol exists. Detailed, well-described protocols can facilitate the understanding and appraisal of the review methods, as well as the detection of modifications to methods and selective reporting in completed reviews. We describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.
              • Record: found
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              RoB 2: a revised tool for assessing risk of bias in randomised trials


                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                August 2022
                30 August 2022
                : 11
                : 8
                : e40134
                [1 ] T H Chan School of Public Health Harvard University Boston, MA United States
                [2 ] Africa Academy for Public Health Dar es Salaam United Republic of Tanzania
                [3 ] Department of Microbiology and Immunology Muhimbili University of Health and Allied Sciences Dar es Salaam United Republic of Tanzania
                Author notes
                Corresponding Author: Sachin Shinde sshinde@ 123456hsph.harvard.edu
                Author information
                ©Sachin Shinde, Dongqing Wang, Mashavu H Yussuf, Mary Mwanyika-Sando, Said Aboud, Wafaie W Fawzi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.08.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 7 June 2022
                : 29 June 2022
                : 8 July 2022
                : 14 July 2022

                antenatal care,multiple micronutrient supplementation,pregnant and lactating women,systematic review and meta-analysis,review,meta-analysis,meta-analyses,low- and middle-income countries,lmic,low income,middle income,women's health,pregnant,pregnancy,natal,maternal,maternity,infant,baby,babies,lactation,lactating,breastfeed,nutrition,vitamin,nutrient,supplement


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