Cargando…
Sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period
BACKGROUND: Postpartum iron deficiency anemia (PPIDA) is highly prevalent in developing countries where it constitutes an important cause of maternal morbidity and mortality. Potential determinants of PPIDA are prepartum iron deficiency or iron deficiency anemia in association with severe blood loss...
Autores principales: | , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10190002/ https://www.ncbi.nlm.nih.gov/pubmed/37198549 http://dx.doi.org/10.1186/s12884-023-05658-7 |
_version_ | 1785043199704694784 |
---|---|
author | Antoine, Edu Mehedintu, Claudia Mitran, Mihai Diculescu, Doru |
author_facet | Antoine, Edu Mehedintu, Claudia Mitran, Mihai Diculescu, Doru |
author_sort | Antoine, Edu |
collection | PubMed |
description | BACKGROUND: Postpartum iron deficiency anemia (PPIDA) is highly prevalent in developing countries where it constitutes an important cause of maternal morbidity and mortality. Potential determinants of PPIDA are prepartum iron deficiency or iron deficiency anemia in association with severe blood loss during delivery. We investigated the efficacy of oral Sucrosomial® iron for recover from mild-to-moderate PPIDA. METHODS: This pilot study was conducted in three medical centers in Romania. Adult women (≥ 18y) with mild (hemoglobin [Hb] 9–11 g/dL) or moderate (Hb 7–9 g/dL) PPIDA diagnosed at screening (2–24 h after delivery) were eligible. Women with mild PPIDA received oral Sucrosomial® iron (Pharmanutra, S.p.A, Italy) once daily (30 mg elemental iron per capsule) for 60 days. Those with moderate PPIDA received oral Sucrosomial® iron twice daily (60 mg elemental iron) for 10 days, followed by a 50-day course of oral Sucrosomial® iron once daily (30 mg elemental iron). Laboratory parameters, as well as subjective clinical symptoms using a 3-point Likert Scale, were assessed at baseline and on study days 10, 30 and 60. RESULTS: Sixty anemic women entered the study, but three were missed during follow-up. At day 60, a Hb rise was observed in both groups (+ 3.6 ± 1.5 g/dL; p < 0.01), 81% experienced correction of anemia (Hb ≥ 12 g/dL), 36% achieved a ferritin concentration ≥ 30 ng/mL (p < 0.05), and 54% a transferrin saturation (TSAT) ≥ 20% (p < 0.01). For women still anemic at day 60, mean Hb was close to normality (11.3 ± 0.8 g/dL). Resolution of IDA-associated clinical symptoms was already observed just 10 days after treatment initiation. No patient discontinued treatment due to gastrointestinal adverse events. CONCLUSIONS: Sucrosomial® iron was shown to be potentially effective and well tolerated at treating mild and moderate PPIDA. These results encourage the use of oral Sucrosomial® iron as a treatment option for PPIDA, but larger studies with longer follow-up are warrant. |
format | Online Article Text |
id | pubmed-10190002 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-101900022023-05-18 Sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period Antoine, Edu Mehedintu, Claudia Mitran, Mihai Diculescu, Doru BMC Pregnancy Childbirth Research BACKGROUND: Postpartum iron deficiency anemia (PPIDA) is highly prevalent in developing countries where it constitutes an important cause of maternal morbidity and mortality. Potential determinants of PPIDA are prepartum iron deficiency or iron deficiency anemia in association with severe blood loss during delivery. We investigated the efficacy of oral Sucrosomial® iron for recover from mild-to-moderate PPIDA. METHODS: This pilot study was conducted in three medical centers in Romania. Adult women (≥ 18y) with mild (hemoglobin [Hb] 9–11 g/dL) or moderate (Hb 7–9 g/dL) PPIDA diagnosed at screening (2–24 h after delivery) were eligible. Women with mild PPIDA received oral Sucrosomial® iron (Pharmanutra, S.p.A, Italy) once daily (30 mg elemental iron per capsule) for 60 days. Those with moderate PPIDA received oral Sucrosomial® iron twice daily (60 mg elemental iron) for 10 days, followed by a 50-day course of oral Sucrosomial® iron once daily (30 mg elemental iron). Laboratory parameters, as well as subjective clinical symptoms using a 3-point Likert Scale, were assessed at baseline and on study days 10, 30 and 60. RESULTS: Sixty anemic women entered the study, but three were missed during follow-up. At day 60, a Hb rise was observed in both groups (+ 3.6 ± 1.5 g/dL; p < 0.01), 81% experienced correction of anemia (Hb ≥ 12 g/dL), 36% achieved a ferritin concentration ≥ 30 ng/mL (p < 0.05), and 54% a transferrin saturation (TSAT) ≥ 20% (p < 0.01). For women still anemic at day 60, mean Hb was close to normality (11.3 ± 0.8 g/dL). Resolution of IDA-associated clinical symptoms was already observed just 10 days after treatment initiation. No patient discontinued treatment due to gastrointestinal adverse events. CONCLUSIONS: Sucrosomial® iron was shown to be potentially effective and well tolerated at treating mild and moderate PPIDA. These results encourage the use of oral Sucrosomial® iron as a treatment option for PPIDA, but larger studies with longer follow-up are warrant. BioMed Central 2023-05-17 /pmc/articles/PMC10190002/ /pubmed/37198549 http://dx.doi.org/10.1186/s12884-023-05658-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Antoine, Edu Mehedintu, Claudia Mitran, Mihai Diculescu, Doru Sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period |
title | Sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period |
title_full | Sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period |
title_fullStr | Sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period |
title_full_unstemmed | Sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period |
title_short | Sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period |
title_sort | sucrosomial® iron effectiveness in recovering from mild and moderate iron-deficiency anemia in the postpartum period |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10190002/ https://www.ncbi.nlm.nih.gov/pubmed/37198549 http://dx.doi.org/10.1186/s12884-023-05658-7 |
work_keys_str_mv | AT antoineedu sucrosomialironeffectivenessinrecoveringfrommildandmoderateirondeficiencyanemiainthepostpartumperiod AT mehedintuclaudia sucrosomialironeffectivenessinrecoveringfrommildandmoderateirondeficiencyanemiainthepostpartumperiod AT mitranmihai sucrosomialironeffectivenessinrecoveringfrommildandmoderateirondeficiencyanemiainthepostpartumperiod AT diculescudoru sucrosomialironeffectivenessinrecoveringfrommildandmoderateirondeficiencyanemiainthepostpartumperiod |