Trial reportThe American journal of clinical nutrition2021
Biofortified and fortified maize consumption reduces prevalence of low milk retinol, but does not increase vitamin A stores of breastfeeding Zambian infants with adequate reserves: a randomized controlled trial.
Trial report in The American journal of clinical nutrition, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02804490 (Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Efficacy of Biofortified Maize to Improve Maternal and Infant Vitamin A Status
Who cites it
8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- Selected laboratory-based biomarkers for assessing vitamin A deficiency in at-risk individuals.The Cochrane database of systematic reviews · 2025Pooled it
- Vitamin A Concentration in Human Milk: A Meta-Analysis.Nutrients · 2022Pooled it
- Health outcomes associated with micronutrient-fortified complementary foods in infants and young children aged 6-23 months: a systematic review and meta-analysis.The Lancet. Child & adolescent health · 2022Pooled it
- Maternal multiple micronutrient supplementation in rural Pakistan increased some milk micronutrient concentrations, but not infant growth, at three-months postpartum: a randomized controlled trial substudy.The American journal of clinical nutrition · 2025Trial
- Maize Biofortification Approaches for Fighting Malnutrition in Sub-Saharan Africa.Plant-environment interactions (Hoboken, N.J.) · 2026Review
- Simulated Impact of Vitamin A-Fortified Sugar on Dietary Adequacy and Association of Usual Sugar Intake With Plasma and Breast Milk Retinol Among Lactating Zambian Women.Maternal & child nutrition · 2025Article
- Article
- Evidence to Underpin Vitamin A Requirements and Upper Limits in Children Aged 0 to 48 Months: A Scoping Review.Nutrients · 2022Article
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundReplacement of conventional staples with biofortified or industrially fortified staples in household diets may increase maternal breast milk retinol content and vitamin A intakes from complementary foods, improving infant total body stores (TBS) of vitamin A.
objectivesTo determine whether biofortified or industrially fortified maize consumption by Zambian women and their breastfeeding infants could improve milk retinol concentration and infant TBS.
methodsWe randomly assigned 255 lactating women and their 9-mo-old infants to a 90-d intervention providing 0 µg retinol equivalents (RE)/d as conventional maize or ∼315 µg RE/d to mothers and ∼55 µg RE/d to infants as provitamin A carotenoid-biofortified maize or retinyl palmitate-fortified maize. Outcomes were TBS, measured by retinol isotope dilution in infants (primary), and breast milk retinol, measured by HPLC in women (secondary).
resultsThe intervention groups were comparable at baseline. Loss to follow-up was 10% (n = 230 mother-infant pairs). Women consumed 92% of the intended 287 g/d and infants consumed 82% of the intended 50 g/d maize. The baseline geometric mean (GM) milk retinol concentration was 1.57 μmol/L (95% CI: 1.45, 1.69 μmol/L), and 24% of women had milk retinol <1.05 μmol/L. While mean milk retinol did not change in the biofortified arm (β: 0.11; 95% CI: -0.02, 0.24), the intervention reduced low milk retinol (RR: 0.42; 95% CI: 0.21, 0.85). Fortified maize increased mean milk retinol (β: 0.17; 95% CI: 0.04, 0.30) and reduced the prevalence of low milk retinol (RR: 0.46; 95% CI: 0.25, 0.82). The baseline GM TBS was 178 μmol (95% CI: 166, 191 μmol). This increased by 24 µmol (± 136) over the 90-d intervention period, irrespective of treatment group.
conclusionsBoth biofortified and fortified maize consumption improved milk retinol concentration. This did not translate into greater infant TBS, most likely due to adequate TBS at baseline. This trial was registered at clinicaltrials.gov as NCT02804490.
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