Trial reportPloS one2022
Bioequivalence of micronutrient powders to Corn-soy Blend on serum zinc concentration of children (6-36 months) with Moderate Acute Malnutrition in Thika urban slums, Kenya: A cluster-randomized controlled trial.
Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 3 citations in OpenAlex.
- Trace Element Intake from Dairy-Free Infant Porridges and Its Nutritional and Safety Implications for Infants Aged Six Months and Older.Nutrients · 2026Article
- Could Urinary Copper/Zinc Ratio Be a Newer Tool to Replace 24-Hour Urinary Copper Excretion for Diagnosing Wilson Disease in Children?Pediatric gastroenterology, hepatology & nutrition · 2024Article
- Home processed complementary foods, caregivers' knowledge, attitude, and practice in a rural community in Kenya: a mixed method study.The Pan African medical journal · 2024Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Zinc deficiency is common among children with Moderate Acute Malnutrition (MAM) and contributes to growth failure, increased morbidity and mortality. Diarrhoea and poor dietary practices are the main causes of zinc deficiency. Corn-soy Blend (CSB), the standard product in management of children with MAM has a limitation of poor micronutrient bioavailability. Micronutrient powders (MNPs) which are added at the point of consumption have a potential in improving micronutrient status however, scientific evidence on efficacy on improving the zinc status is scarce. A cluster-randomized clinical trial was designed to establish bioequivalence of MNPs to CSB on serum zinc status among children (6-36 months) with MAM in Thika informal settlements, Kenya. Sample size was calculated to show bioequivalence within ±20% limit. Twelve villages were randomized to four study groups. Three experimental groups received different formulations of MNPs added to unfortified CSB porridge as; multiple micronutrients containing zinc (CSB-MNP-A n = 84), multiple micronutrients without zinc (CSB-MNP-B n = 88) and zinc only (CSB-MNP-C n = 94). Control group (n = 80) received standard CSB fortified with multiple micronutrients. Standard amount of CSB was consumed in feeding centres for six months. Serum zinc concentration was assessed pre- and post-intervention. Data was analyzed based on treatment assignment regardless of adherence and drop-out status. Mixed effects linear regression was used to model pre-post change in serum zinc concentration, adjusting for clustering effect and baseline differences. Bioequivalence was assessed using two one-sided t-tests. At baseline, 84.4% were zinc deficient (serum zinc <65μg/dL) and zinc intake was sub-optimal (<3 mg/day) for 95.7% of children. Mean change in serum zinc concentration was significantly higher (p = 0.024) in CSB-MNP-A (18.7 ± 2.1) μg/dL compared to control group (11.8 ± 2.6 μg/dL). MNPs are not bioequivalent to CSB within the ±20% bioequivalence limit. MNPs are more effective in improving serum zinc status compared to CSB. Trials with larger sample sizes are recommended to validate the current findings. Trial registration: Pan African Clinical Trials Registry: PACTR201907492232376.
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