Ferrous sulfate 325mg / Folic acid 350microgram modified-release tablets

BackgroundThis review aims to assess the effect of oral administration of probiotics and/or prebiotics in children and women of reproductive age (WRA) to improve intestinal iron absorption, hemoglobin, and ferritin levels.MethodsRandomized controlled trials from published literature on probiotics and or prebiotics for prevention or treatment of anemia as a supplement or fortification in children or WRA till Jan 31, 2023, were included. Studies on probiotics and prebiotics in patients with anemia due to other causes were excluded. Screening and data extraction was done using Distiller SR and meta-analysis was performed using Revman 5.4.1.ResultsA total of 1925 records were identified from Pubmed, Embase, and Cochrane, of which 29 were included in the systematic review (14 supplementation and 15 fortification studies; 15 studies in children and 14 studies in WRA). The major interventions included galacto-oligosaccharide, inulin, heat-killed H61, Lactobacillus plantarum 299v, Lactobacillus reuteri, Lactobacillus acidophilus. Meta-analysis of 5 studies in WRA showed that the use of prebiotics and/or probiotics with or without iron was associated with little or no effect on hemoglobin. However, there is low certainty of evidence that the intervention led to improvement in fractional absorption of iron as compared to placebo or iron [8 studies, n = 335, mean increase 0.74%, 95%CI-0.11-1.38, p = 0.02]. Meta-analysis of 6 studies in WRA using prebiotics and/or probiotics with or without iron led to a significant increase in ferritin levels in WRA (mean increase 2.45 ng/ml, 95% CI 0.61-4.3, p = 0.009, n = 320) [Moderate certainty of evidence]. In children, meta-analysis of up to 8 studies did not result in any significant change in hemoglobin, ferritin and fractional iron absorption [low or very low certainty of evidence].ConclusionThere is some evidence to show that the use of prebiotics or probiotics (especially Lp299v and GOS) with or without oral iron can improve iron absorption in women and lead to improvement in ferritin levels in women. However, the current evidence does not conclusively show the benefit of these interventions in improving hemoglobin levels in women and children.

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Nutritional deficiencies are prevalent in populations across the world. Fortification of staple foods has been used as an alternative to supplementation to address many deficiencies. One such staple is salt, which has long been fortified with iodine, but more recently with iron, folate, and other micronutrients. Our objective was to determine the effects of fortified salt on nutritional and health outcomes among children, adolescents, and adults. We conducted a systematic review of published and unpublished literature using a pre-defined search strategy. Abstracts and full texts were screened for randomized trials, quasi-randomized trials, and pre-post-designs of double or multiple fortified salt. We calculated the weighted pooled effect sizes for the effects of fortified salt on nutritional and health outcomes. Of the 395 studies identified, 33 (including 37 intervention-control comparisons) fit our inclusion criteria. Of these comparisons, 26 studied the effects of salt fortified with iron and iodine [double fortified salt (DFS)], 2 studied the effects of salt fortified with folic acid and iodine, 1 studied the effect of triple fortified salt, 1 studied the effect of quadruple fortified salt, and 7 studied the effects of multiple micronutrient fortified salt (MMFS; fortified with ≥5 nutrients). Pooled effect sizes indicated positive effects from all iron-containing fortified salt on hemoglobin concentration [standardized mean difference (95% confidence interval): DFS 0.36 (0.22, 0.50), n comparisons = 26; triple fortified salt 1.56 (1.42, 1.70), n comparisons = 1; quadruple fortified salt 0.33 (0.02, 0.63), n comparisons = 1; MMFS 0.23 (0.03, 0.43), n comparisons = 6]. DFS and MMFS reduced the odds of anemia and iron deficiency (ID) anemia. MMFS improved serum folate and reduced the odds of ID. Pooled effects on biomarkers of vitamin B12, vitamin A, and zinc status varied by type of salt, but were largely not significant. Fortification of salt with iodine and iron, with and without other nutrients, is effective in increasing hemoglobin and reducing the odds of anemia and ID in population-based studies.

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Ferric carboxymaltose (FCM) is widely used to correct anemia and replenish iron stores rapidly, particularly in Western populations. However, lower doses of FCM are typically used in East Asia, with limited research on their effectiveness, especially in postpartum women. This randomized controlled trial aimed to assess the efficacy of low-dose FCM compared with oral ferrous sulfate in increasing postpartum hemoglobin (Hb) levels and replenishing iron stores in East Asian women. Sixty postpartum women with Hb levels < 10 g/dL and serum ferritin ≤ 30 ng/mL were randomized to receive either intravenous FCM (500 mg at baseline and 2 weeks) or oral ferrous sulfate (210 mg daily for 4 weeks). The primary outcome was the increase in Hb levels at 2 weeks post-enrollment. Secondary outcomes included serum ferritin, transferrin saturation, the Edinburgh Postnatal Depression Scale (EPDS) score, and adverse events at 4 weeks. The FCM group demonstrated a significantly greater increase in Hb levels at 2 weeks (mean difference 0.42 g/dL; 95% CI: 0.12-0.72; P =  0.006), with markedly higher ferritin (adjusted mean difference 356.0 ng/mL; 95% CI: 321.0-403.0; P <  0.001) and transferrin saturation (adjusted mean difference 10.76%; 95% CI: 4.20-17.31; P =  0.002) at 4 weeks. Although there was no significant difference in final Hb levels at 4 weeks (mean difference 0.36 g/dL; 95% CI: -0.01-0.72; P =  0.055), the FCM group had a lower median EPDS score (median difference -3.0; 95% CI: -5.0 to -1.0; P =  0.002) and fewer gastrointestinal side effects, including constipation and nausea. Hypophosphatemia occurred asymptomatically in three patients in the FCM group. These findings suggest that low-dose FCM infusion is highly effective in increasing Hb levels at 2 weeks post-enrollment, with fewer gastrointestinal side effects and higher ferritin levels observed at 4 weeks post-enrollment compared with oral ferrous sulfate. This study was registered at the UMIN Clinical Trials Registry, which meets the requirements of the ICMJE, on December 1, 2021 (ID: UMIN000046049).

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BackgroundAdding Drakshavaleha to iron-folic acid (IFA) supplementation could lead to a significant increase in hemoglobin (Hb) levels compared to IFA alone due to its bioavailability-enhancing property. This paper presents a protocol for the randomized controlled trial (RCT) assessing the efficacy and safety of integrating Drakshavaleha with IFA supplementation in improving hemoglobin levels among women aged 18-49 years with mild to moderate iron-deficiency anaemia.MethodsThis parallel-group, open-label, community-based randomized controlled trial will include women aged 18 to 49 years with mild (Hb 11-11.9 g/dL) to moderate (Hb 8-10.9 g/dL) iron deficiency anaemia. Consecutive participants meeting the inclusion/exclusion criteria will be enrolled after providing written informed consent and randomly assigned to one of two groups in a 1:1 ratio using block randomization. The control group will receive 200 mg of ferrous sulphate and 0.5 mg of folic acid orally, twice daily after food for 3 months. The intervention group will receive 6 g of Drakshavaleha orally, twice daily before food, in addition to the same IFA dosage as the control group. Participants will be followed up monthly at 1, 2 and 3 months. At all follow-up visits, CBC and iron profiles will be done whereas serum creatinine, serum bilirubin, serum glutamic pyruvic aminotransferase (SGPT), and HbA1C will be done at 3 months.ConclusionThis protocol outlines the RCT to assess the efficacy and safety of integrating Drakshavaleha with IFA supplements and explore Drakshavaleha's role in enhancing assimilation of oral iron from supplements and nutrition.Trial registration numberThe trial is registered in Clinical Trials Registry - India (CTRI) under registration number CTRI/2024/05/067169.

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