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Meta-Analysis
. 2021 Jan 18;1(1):CD011302.
doi: 10.1002/14651858.CD011302.pub3.

Wheat flour fortification with iron and other micronutrients for reducing anaemia and improving iron status in populations

Martha S Field  1 , Prasanna Mithra  2 , Juan Pablo Peña-Rosas  3
Affiliations
Meta-Analysis

Wheat flour fortification with iron and other micronutrients for reducing anaemia and improving iron status in populations

Martha S Field et al. Cochrane Database Syst Rev. .

Abstract

Background: Anaemia is a condition where the number of red blood cells (and consequently their oxygen-carrying capacity) is insufficient to meet the body's physiological needs. Fortification of wheat flour is deemed a useful strategy to reduce anaemia in populations.

Objectives: To determine the benefits and harms of wheat flour fortification with iron alone or with other vitamins and minerals on anaemia, iron status and health-related outcomes in populations over two years of age.

Search methods: We searched CENTRAL, MEDLINE, Embase, CINAHL, 21 other databases and two trials registers up to 21 July 2020, together with contacting key organisations to identify additional studies.

Selection criteria: We included cluster- or individually-randomised controlled trials (RCTs) carried out among the general population from any country, aged two years and above. The interventions were fortification of wheat flour with iron alone or in combination with other micronutrients. We included trials comparing any type of food item prepared from flour fortified with iron of any variety of wheat DATA COLLECTION AND ANALYSIS: Two review authors independently screened the search results and assessed the eligibility of studies for inclusion, extracted data from included studies and assessed risks of bias. We followed Cochrane methods in this review.

Main results: Our search identified 3538 records, after removing duplicates. We included 10 trials, involving 3319 participants, carried out in Bangladesh, Brazil, India, Kuwait, Philippines, South Africa and Sri Lanka. We identified two ongoing studies and one study is awaiting classification. The duration of interventions varied from 3 to 24 months. One study was carried out among adult women and one trial among both children and nonpregnant women. Most of the included trials were assessed as low or unclear risk of bias for key elements of selection, performance or reporting bias. Three trials used 41 mg to 60 mg iron/kg flour, three trials used less than 40 mg iron/kg and three trials used more than 60 mg iron/kg flour. One trial used various iron levels based on type of iron used: 80 mg/kg for electrolytic and reduced iron and 40 mg/kg for ferrous fumarate. All included studies contributed data for the meta-analyses. Iron-fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with the same other micronutrients added Iron-fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with the same other micronutrients added may reduce by 27% the risk of anaemia in populations (risk ratio (RR) 0.73, 95% confidence interval (CI) 0.55 to 0.97; 5 studies, 2315 participants; low-certainty evidence). It is uncertain whether iron-fortified wheat flour with or without other micronutrients reduces iron deficiency (RR 0.46, 95% CI 0.20 to 1.04; 3 studies, 748 participants; very low-certainty evidence) or increases haemoglobin concentrations (in g/L) (mean difference MD 2.75, 95% CI 0.71 to 4.80; 8 studies, 2831 participants; very low-certainty evidence). No trials reported data on adverse effects in children (including constipation, nausea, vomiting, heartburn or diarrhoea), except for risk of infection or inflammation at the individual level. The intervention probably makes little or no difference to the risk of Infection or inflammation at individual level as measured by C-reactive protein (CRP) (mean difference (MD) 0.04, 95% CI -0.02 to 0.11; 2 studies, 558 participants; moderate-certainty evidence). Iron-fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added) It is unclear whether wheat flour fortified with iron, in combination with other micronutrients decreases anaemia (RR 0.77, 95% CI 0.41 to 1.46; 2 studies, 317 participants; very low-certainty evidence). The intervention probably reduces the risk of iron deficiency (RR 0.73, 95% CI 0.54 to 0.99; 3 studies, 382 participants; moderate-certainty evidence) and it is unclear whether it increases average haemoglobin concentrations (MD 2.53, 95% CI -0.39 to 5.45; 4 studies, 532 participants; very low-certainty evidence). No trials reported data on adverse effects in children. Nine out of 10 trials reported sources of funding, with most having multiple sources. Funding source does not appear to have distorted the results in any of the assessed trials.

Authors' conclusions: Fortification of wheat flour with iron (in comparison to unfortified flour, or where both groups received the same other micronutrients) may reduce anaemia in the general population above two years of age, but its effects on other outcomes are uncertain. Iron-fortified wheat flour in combination with other micronutrients, in comparison with unfortified flour, probably reduces iron deficiency, but its effects on other outcomes are uncertain. None of the included trials reported data on adverse side effects except for risk of infection or inflammation at the individual level. The effects of this intervention on other health outcomes are unclear. Future studies at low risk of bias should aim to measure all important outcomes, and to further investigate which variants of fortification, including the role of other micronutrients as well as types of iron fortification, are more effective, and for whom.

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Conflict of interest statement

Martha Field ‐ none known.

Juan Pablo Peña‐Rosas ‐ the WHO receives partial financial support from the Bill & Melinda Gates Foundation, Global Alliance for Improved Nutrition and Nutrition International to support its work in the area of nutrition, including the commissioning of systematic reviews of interventions for health throughout the life course.

Prasanna Mithra ‐ none known.

Figures

1
1
WHO/CDC generic logic model for micronutrient interventions (with permission from WHO)
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: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 1: Anaemia (haemoglobin below WHO cut‐off for age, adjusted for altitude)
1.2
1.2. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 2: Anaemia (subgroup: by prevalence of anaemia at baseline)
1.3
1.3. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 3: Anaemia (subgroup: by type or iron compound)
1.4
1.4. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 4: Anaemia (subgroup: by duration of intervention)
1.5
1.5. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 5: Anaemia (subgroup: by amount of elemental iron added to flour)
1.6
1.6. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 6: Iron deficiency (as defined by study authors, based on a biomarker of iron status)
1.7
1.7. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 7: Haemoglobin concentration (g/L)
1.8
1.8. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 8: Haemoglobin concentration (subgroup: by prevalence of anaemia at baseline (g/L))
1.9
1.9. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 9: Haemoglobin concentration (subgroup: by type of iron compound (g/L))
1.10
1.10. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 10: Haemoglobin concentration (subgroup: by duration of intervention (g/L))
1.11
1.11. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 11: Haemoglobin concentration (subgroup: by amount of elemental iron added to flour (g/L))
1.12
1.12. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 12: Haemoglobin concentration (subgroup: by iron alone or combination)
1.13
1.13. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 13: Infection or inflammation (CRP) (only in children 2 to 11 years of age)
1.14
1.14. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 14: Height‐for‐age z‐score (in children)
1.15
1.15. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 15: Weight‐for‐age z‐score (in children)
1.16
1.16. Analysis
Comparison 1: Iron‐fortified wheat flour with or without other micronutrients added versus wheat flour (no added iron) with or without other micronutrients added, Outcome 16: Cognitive development (in children)
2.1
2.1. Analysis
Comparison 2: Iron‐fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added), Outcome 1: Anaemia (haemoglobin below WHO cut‐off for age and adjusted for altitude)
2.2
2.2. Analysis
Comparison 2: Iron‐fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added), Outcome 2: Iron deficiency (as defined by study authors, based on a biomarker of iron status)
2.3
2.3. Analysis
Comparison 2: Iron‐fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added), Outcome 3: Haemoglobin concentration (g/L)
2.4
2.4. Analysis
Comparison 2: Iron‐fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added), Outcome 4: Haemoglobin concentration (subgroup: by type of iron compound (g/L))
2.5
2.5. Analysis
Comparison 2: Iron‐fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added), Outcome 5: Haemoglobin concentration (subgroup: by amount of elemental iron added to flour (g/L))
2.6
2.6. Analysis
Comparison 2: Iron‐fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added), Outcome 6: Height‐for‐age z‐score (in children)
2.7
2.7. Analysis
Comparison 2: Iron‐fortified wheat flour with other micronutrients added versus unfortified wheat flour (nil micronutrients added), Outcome 7: Weight‐for‐age z‐score (in children)
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Update of

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References to studies awaiting assessment

Metwally 2020 {published data only}
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References to ongoing studies

Arcot 2017 {unpublished data only}
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References to other published versions of this review

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