Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2015
Supplemented vs. unsupplemented human milk on bone mineralization in very low birth weight preterm infants: a randomized clinical trial.
Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.
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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.
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Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.
- Fortified Human Milk Compared with Unfortified Human Milk in Preterm Low Birth Weight Neonates: A Systematic Review and Meta-Analysis.Nutrients · 2026Pooled it
- Multi-nutrient fortification of human milk for preterm infants.The Cochrane database of systematic reviews · 2020Pooled it
- Higher bone mineral density at six years of age in very preterm-born infants fed human milk compared to formula feeding. A secondary analysis of an RCT.European journal of pediatrics · 2025Trial
- Trial
- Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial.Journal of pediatric gastroenterology and nutrition · 2017Trial
- Early Life Programming of Skeletal Health.Current osteoporosis reports · 2023Review
- Regulation of Gut Microbiota through Breast Milk Feeding Benefits Language and Cognitive Development of Preterm Toddlers.Microorganisms · 2023Article
- Associated neonatal and maternal factors of osteopenia of prematurity in low resource setting: A cross-sectional study.Annals of medicine and surgery (2012) · 2021Article
- Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
unlabelledVery low birth weight preterm newborns weighing less than 1500 g were randomized to receive human milk supplemented with FM 85® or not. They have similar bone mineral content (BMC) at baseline, but, at the end of study, BMC was increasingly higher in the FM 85® group.
introductionThe purpose of this study is to evaluate the effectiveness of a human milk supplement (FM 85®; Nestlé, Vevey, Switzerland) developed for the purpose of improving nutrition, including bone mineralization, in very low birth weight preterm newborns.
methodsPreterm infants weighing less than 1500 g at birth admitted to the neonatal intensive care unit of a university hospital were studied. During hospitalization, they were fed at least 50 % of human milk. Newborns with ≥20 days of age were randomly assigned to the intervention group (n = 19) to receive human milk supplemented with FM 85® or to a control group (n = 19) to receive human milk only. Anthropometric measurements, whole-body bone densitometry (DXA), and biochemical tests were performed at study entry and at the end of the study (shortly before discharge when the infant had reached 2000 g).
resultsThere were no start- or end-of-study differences between the two groups, except for daily increase in length (p = 0.010). At baseline, both groups had similar BMC: 5.49 ± 3.65 vs. 4.34 ± 2.98 g (p = 0.39) for the intervention and control group, respectively. However, at the end of the study, BMC was higher in the intervention group: 10.3 ± 4.71 vs. 6.19 ± 3.23 g (p = 0.003). The mean increase in BMC during the observation period was 4.90 ± 4.46 g for the intervention group and 1.86 ± 3.17 g for the control group (p = 0.020). Serum alkaline phosphatase levels were higher in the control group (720 ± 465 vs. 391 ± 177 IU/L; p = 0.007).
conclusionsOur data suggest that supplementation of human milk with FM 85® leads to improved bone mineralization in very low birth weight preterm newborns.
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