Ferrous gluconate 250mg / Folic acid 4mg modified-release tablets

BackgroundPre-eclampsia can lead to maternal and neonatal complications and is a common cause of maternal mortality worldwide. This review has examined the effect of micronutrient supplementation interventions in women identified as having a greater risk of developing pre-eclampsia.MethodsA systematic review was performed using the PRISMA guidelines. The electronic databases MEDLINE, EMBASE and the Cochrane Central Register of Controlled trials were searched for relevant literature and eligible studies identified according to a pre-specified criteria. A meta-analysis of randomised controlled trials (RCTs) was conducted to examine the effect of micronutrient supplementation on pre-eclampsia in high-risk women.ResultsTwenty RCTs were identified and supplementation included vitamin C and E (n = 7), calcium (n = 5), vitamin D (n = 3), folic acid (n = 2), magnesium (n = 1) and multiple micronutrients (n = 2). Sample size and recruitment time point varied across studies and a variety of predictive factors were used to identify participants, with a previous history of pre-eclampsia being the most common. No studies utilised a validated prediction model. There was a reduction in pre-eclampsia with calcium (risk difference, -0.15 (-0.27, -0.03, I2 = 83.4%)), and vitamin D (risk difference, -0.09 (-0.17, -0.02, I2 = 0.0%)) supplementation.ConclusionOur findings show a lower rate of pre-eclampsia with calcium and vitamin D, however, conclusions were limited by small sample sizes, methodological variability and heterogeneity between studies. Further higher quality, large-scale RCTs of calcium and vitamin D are warranted. Exploration of interventions at different time points before and during pregnancy as well as those which utilise prediction modelling methodology, would provide greater insight into the efficacy of micronutrient supplementation intervention in the prevention of pre-eclampsia in high-risk women.

Abstract licence: CC BY

BackgroundPatients with a low serum blood hemoglobin concentration suffer from a pathologic state that contributes significantly to morbidity and mortality figures worldwide. Oral iron supplementation, the most common method of treatment, is reported to have poor patient adherence, due to its unwanted side effects. Lactoferrin is a globular glycoprotein of the transferrin family that has shown promising results in patients with a low hemoglobin profile. This systematic review and meta-analysis of randomized clinical trials explore its effect on blood hemoglobin compared to conventional iron preparations.MethodsWe followed the PRISMA Guidelines for reporting systematic reviews and meta-analyses. A systematic search was conducted in electronic databases (PubMed, CINAHL, Scopus, and Cochrane) from inception to June 2022. Meta-analysis was performed on studies where the primary outcome was the mean Hb concentration, comparing lactoferrin to ferrous sulfate subgroups. We assessed the methodological quality of the trials using the Jadad scoring scale.ResultsNineteen trials published between 2006 and 2022 met the eligibility criteria. It has been found that the levels of Hb concentration in different populations with varying health conditions undergo a moderate to significant change after treatment with all types of trialed interventions, including both iron and lactoferrin treatment, in both the intervention group and the comparison group. Most of the studies report that LF showed a statistically significant increase in Hb concentration levels, compared to those in the iron group. The meta-analysis included seven trials comparing the effectiveness of lactoferrin to ferrous sulfate for patients with low Hb concentration. The analysis showed a statistically significant increase in Hb levels in the oral bovine lactoferrin group compared to ferrous sulfate (SMD -0.81, 95% CI: -1.21, -0.42, p 2 = 95.8%, P heterogeneity ConclusionsLactoferrin is an effective intervention at doses of 100-250 ng/day, for patients with a low Hb concentration. As a safer option and with high compliance evidence, lactoferrin can serve as an iron replacement treatment for patients who may be experiencing adverse side effects due to iron intake.

Abstract licence: CC BY

IntroductionAnemia remains a prevalent global health issue with varying severity. Intravenous iron supplementation, particularly with ferric carboxymaltose (FCM), has appeared as a possible therapeutic intervention for individuals with moderate to severe anemia. The study aimed to assess the efficacy and safety of ferric carboxymaltose (FCM) in reducing anemia.MethodsWe searched electronic databases, registries, websites, e-libraries, reference lists of reviews, citations, etc. We included randomized control trials (RCTs), non-RCTs, and single-arm studies, while observational studies, case series, and case studies were excluded. Two reviewers independently screened the studies and extracted the data. We included studies of moderate-to-severely anemic Indians and excluded Indians with other comorbidities. We assessed the risk of bias and the overall quality of evidence (QoE) using GRADE GDT.ResultWe identified 255 studies and included 14 studies (11 RCT, one non-RCT, and two single-arm studies) with 1,972 participants for qualitative analysis and 10 studies in the meta-analysis. All the included studies detailed the use of FCM for anemia. The primary outcomes assessed in the included studies were anemia, hemoglobin, and adverse events. The outcomes assessed ranged from 2 weeks to 12 weeks. The risk of bias varied across different studies with different outcomes. FCM is consistent with a fewer number of adverse events as compared to other interventions and provides "moderate" to "very low" QoE.ConclusionA slow single infusion of 1 gram of FCM is well-tolerated, safe, and effective in treating iron deficiency anemia (IDA) and surpasses other interventions (Iron Sucrose Complex (ISC), Iron sucrose, and ferrous ascorbate) in elevating hemoglobin levels and replenishing iron stores.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?RecordID=459363, CRD42023459363.

Abstract licence: CC BY

In the US, 70% of pregnant women use an iron-containing prenatal supplement product; however, only 2.6% of pregnant women have iron-deficiency anemia and 16.3% are iron deficient. Yet, published data on the amounts and chemical forms of iron used in formulating these products are not available, although they are known to affect bioavailability. This information is especially important in comparing commercially available products with those that were tested in clinical trials. Our examination of nonprescription and prescription iron-containing prenatal supplement products in NIH's Dietary Supplement Label Database (DSLD) and DailyMed found the labeled amount of elemental iron ranged between 9 and 60 mg/serving in 148 nonprescription supplements and between 4.5 and 106 mg/serving in 101 prescription supplements. Ferrous fumarate was the preferred chemical form used in these products. In contrast, ferrous sulfate was the preferred chemical form of iron reported in the clinical trials summarized in a 2015 Cochrane Systematic review assessing the effects of daily oral iron supplements for pregnant women. Ferrous sulfate was not found on any prenatal supplement product label in the DSLD or DailyMed. The chemical forms of products on the market and those tested in clinical trials are dissimilar, and we believe this may have clinical implications. The findings raise several questions. Do outcomes in clinical trials correlate with the benefits and risks that might adhere to iron supplements with different iron formulations? Should the differences in chemical forms, their bioavailability, and safety profiles, be considered in greater depth when evaluating the effect of the various formulations on maternal iron nutriture? Should new clinical trials for pregnant and lactating women in the US use a form of iron not found in prenatal supplements sold in the US or should a more common form be used?

Abstract licence: Public domain

BackgroundThe UN Sustainable Development Goal aims at a 50% reduction of anemia in women of reproductive age (WRA) by 2030. Several nutrition-specific and sensitive interventions are targeted across low- and middle-income countries (LMICs) to reduce anemia.ObjectivesIn this meta-review we comprehensively assessed the effectiveness of nutrition-specific and -sensitive interventions on hemoglobin (Hb) and serum ferritin (SF) concentrations and the prevalence of iron deficiency and anemia among WRA, pregnant women, and lactating women from LMICs.MethodThe preparation of the present meta-review followed a double-blinded synthesis process with 3 stages: screening, quality appraisal, and data extraction in Eppi Reviewer. A comprehensive search was performed for systematic reviews (SRs) published between January 2000 and May 2022 using 21 international, national, and regional databases. The methodological quality appraisal of included studies was conducted using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) checklist.ResultsA total of 23 SRs evaluated the effects of various nutrition-specific interventions included in the final synthesis. The included SRs included analyses of nutrition-specific interventions such as supplementation of the nutrients iron (n = 7), iron and folic acid (n = 4), vitamin A (n = 3), calcium (n = 2), multiple micronutrients (n = 7), and intravenous iron sucrose (n = 2). Also, SRs on fortification of nutrients included multiple micronutrients (n = 6), iron and folic acid (n = 4), and iron (n = 4). Of the 23 SRs, 22 were of high quality. Iron with or without folic acid supplementation and fortification and vitamin A supplementation consistently showed positive effects on either reduction in the prevalence of anemia or iron deficiency and improving the Hb or SF concentrations in WRA and pregnant women from LMICs.ConclusionThe comprehensive meta-review reported the beneficial effects of iron with or without folic acid, multiple micronutrient supplementation/fortification, and vitamin A supplementation in reducing the prevalence of anemia or iron deficiency and increasing Hb or SF concentrations in WRA from LMICs.

Abstract licence: CC BY