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Meta-Analysis
. 2018 Dec 22;12(12):CD010187.
doi: 10.1002/14651858.CD010187.pub2.

Fortification of maize flour with iron for controlling anaemia and iron deficiency in populations

Maria N Garcia-Casal  1 , Juan Pablo Peña-Rosas, Luz Maria De-Regil, Jeffrey A Gwirtz, Sant-Rayn Pasricha
Affiliations
Meta-Analysis

Fortification of maize flour with iron for controlling anaemia and iron deficiency in populations

Maria N Garcia-Casal et al. Cochrane Database Syst Rev. .

Abstract

Background: Approximately 800 million women and children have anaemia, a condition thought to cause almost 9% of the global burden of years lived with disability. Around half this burden could be amenable to interventions that involve the provision of iron. Maize (corn) is one of the world's most important cereal grains and is cultivated across most of the globe. Several programmes around the world have fortified maize flour and other maize-derived foodstuffs with iron and other vitamins and minerals to combat anaemia and iron deficiency.

Objectives: To assess the effects of iron fortification of maize flour, corn meal and fortified maize flour products for anaemia and iron status in the general population.

Search methods: We searched the following international and regional sources in December 2017 and January 2018: Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; MEDLINE (R) In Process; Embase; Web of Science (both the Social Science Citation Index and the Science Citation Index); CINAHL Ebsco; POPLINE; AGRICOLA (agricola.nal.usda.gov); BIOSIS (ISI); Bibliomap and TRoPHI; IBECS; Scielo; Global Index Medicus - AFRO (includes African Index Medicus); EMRO (includes Index Medicus for the Eastern Mediterranean Region); LILACS; PAHO (Pan American Health Library); WHOLIS (WHO Library); WPRO (includes Western Pacific Region Index Medicus); IMSEAR, Index Medicus for the South-East Asian Region; IndMED, Indian medical journals; and the Native Health Research Database. We searched clinicaltrials.gov and the International Clinical Trials Registry Platform (ICTRP) for any ongoing or planned studies on 17 January 2018 and contacted authors of such studies to obtain further information or eligible data if available.For assistance in identifying ongoing or unpublished studies, we also contacted relevant international organisations and agencies working in food fortification on 9 August 2016.

Selection criteria: We included cluster- or individually randomised controlled trials and observational studies. Interventions included (central/industrial) fortification of maize flour or corn meal with iron alone or with other vitamins and minerals and provided to individuals over 2 years of age (including pregnant and lactating women) from any country.

Data collection and analysis: Two review authors independently assessed the eligibility of studies for inclusion, extracted data from included studies and assessed the risk of bias of the included studies. Trial designs with a comparison group were included to assess the effects of interventions. Trial designs without a control or comparison group (uncontrolled before-and-after studies) were included for completeness but were not considered in assessments of the overall effectiveness of interventions or used to draw conclusions regarding the effects of interventions in the review.

Main results: Our search yielded 4529 records. After initial screening of titles and abstracts, we reviewed the full text of 75 studies (80 records). We included 5 studies and excluded 70. All the included studies assessed the effects of providing maize products fortified with iron plus other vitamins and minerals versus unfortified maize flour. No studies compared this intervention to no intervention or looked at the relative effect of flour and products fortified with iron alone (without other vitamins and minerals). Three were randomised trials involving 2610 participants, and two were uncontrolled before-and-after studies involving 849 participants.Only three studies contributed data for the meta-analysis and included children aged 2 to 11.9 years and women. Compared to unfortified maize flour, it is uncertain whether fortifying maize flour or corn meal with iron and other vitamins and minerals has any effect on anaemia (risk ratio (RR) 0.90, 95% confidence interval (CI) 0.58 to 1.40; 2 studies; 1027 participants; very low-certainty evidence), or on the risk of iron deficiency (RR 0.75, 95% CI 0.49 to 1.15; 2 studies; 1102 participants; very low-certainty evidence), haemoglobin concentration (mean difference (MD) 1.25 g/L, 95% CI -2.36 to 4.86 g/L; 3 studies; 1144 participants; very low-certainty evidence) or ferritin concentrations (MD 0.48 µg/L, 95% CI -0.37 to 1.33 µg/L; 1 study; 584 participants; very low-certainty evidence).None of the studies reported on any adverse effects. We judged the certainty of the evidence to be very low based on GRADE, so we are uncertain whether the results reflect the true effect of the intervention. We downgraded evidence due to high risk of selection bias and unclear risk of performance bias in one of two included studies, high heterogeneity and wide CIs crossing the line of no effect for anaemia prevalence and haemoglobin concentration.

Authors' conclusions: It is uncertain whether fortifying maize flour with iron and other vitamins and minerals reduces the risk of anaemia or iron deficiency in children aged over 2 years or in adults. Moreover, the evidence is too uncertain to conclude whether iron-fortified maize flour, corn meal or fortified maize flour products have any effect on reducing the risk of anaemia or on improving haemoglobin concentration in the population.We are uncertain whether fortification of maize flour with iron reduces anaemia among the general population, as the certainty of the evidence is very low. No studies reported on any adverse effects.Public organisations funded three of the five included studies, while the private sector gave grants to universities to perform the other two. The presence of industry funding for some of these trials did not appear to positively influence results from these studies.The reduced number of studies, including only two age groups (children and women of reproductive age), as well as the limited number of comparisons (only one out of the four planned) constitute the main limitations of this review.

PubMed Disclaimer

Conflict of interest statement

Sant‐Rayn S Pasricha ‐ has received an unrestricted research grant as a co‐investigator from Vifor Pharma Ltd and has served as a consultant to the Meat & Livestock Authority Australia.

Luz Maria De‐Regil ‐ works for Nutrition International, an international non‐governmental organisation that supports, among other interventions, fortification programmes and implementation research of maize and wheat flours, rice and condiments. None of these research studies met the inclusion criteria of this review. She is currently a member of the executive management committee of Food Fortification Initiative. The authors alone are responsible for the views expressed in this publication, and they do not necessarily represent the decisions, policy or views of FFI or Nutrition International.

Maria Nieves Garcia‐Casal is an author of some studies on iron fortification of maize flour, none of which were included in the review.

Juan Pablo Peña‐Rosas ‐ none known.

Jeff Gwirtz is currently president at JAG Service Inc, a consulting firm that provides technical advising, research, training and trouble‐shooting in the US and international grain‐based foods sectors. He was not involved in the screening or selection of the studies and provided technical support for the preparation of the Background section and overall interpretation of the results and conclusions.

Figures

1
1
Logic model for maize flour and corn meal fortification with iron and other micronutrients in public health (adapted from WHO/CDC 2011)
2
2
Study flow diagram.
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
4
4
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Maize flour or maize flour products fortified with iron plus other vitamins and minerals versus unfortified maize flours or maize flour products (not containing iron nor any other vitamin and minerals), Outcome 1 Anaemia (defined as haemoglobin (Hb) below WHO cut‐off, adjusted for altitude and smoking, as appropriate).
1.2
1.2. Analysis
Comparison 1 Maize flour or maize flour products fortified with iron plus other vitamins and minerals versus unfortified maize flours or maize flour products (not containing iron nor any other vitamin and minerals), Outcome 2 Iron deficiency (as defined by trialists, based on a biomarker of iron status).
1.3
1.3. Analysis
Comparison 1 Maize flour or maize flour products fortified with iron plus other vitamins and minerals versus unfortified maize flours or maize flour products (not containing iron nor any other vitamin and minerals), Outcome 3 Haemoglobin concentration (in g/L).
1.4
1.4. Analysis
Comparison 1 Maize flour or maize flour products fortified with iron plus other vitamins and minerals versus unfortified maize flours or maize flour products (not containing iron nor any other vitamin and minerals), Outcome 4 Ferritin concentrations (in µg/L).
1.5
1.5. Analysis
Comparison 1 Maize flour or maize flour products fortified with iron plus other vitamins and minerals versus unfortified maize flours or maize flour products (not containing iron nor any other vitamin and minerals), Outcome 5 Iron‐deficiency anaemia (as defined by trialists).
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References to other published versions of this review

Pasricha 2012
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