Ferrous sulfate 325mg / Ascorbic acid 500mg modified-release tablets

BACKGROUND: Iron-Folic Acid (IFA) supplementation during pregnancy is widely recommended to prevent maternal anemia and improve birth outcomes. However, the optimal formulation, dose, and frequency of IFA supplementation remain uncertain. This systematic review and meta-analysis aimed to evaluate the effect of different IFA formulations, doses, and frequencies on pregnancy and neonatal outcomes compared to Multiple Micronutrients (MMN) among pregnant women. METHODS: A comprehensive literature search was conducted across PubMed, Google Scholar, Cochrane Library, Scopus, and TRIP databases to identify pertinent studies published up to December 31st, 2023. Outcome measures includes preterm birth (PTB), stillbirths, low birth weight (LBW), small for gestational age (SGA), miscarriage rate (MR), neonatal mortality, and perinatal mortality. Pooled risk ratios (RRs) with 95% confidence intervals (CIs) were calculated, and the quality of evidence was assessed using GRADEpro. RESULTS: Among 20 studies comparing IFA to MMN, our analysis showed a significant increased risk with LBW (RR: 1.07, 95% CI: 1.01 to 1.13, p = 0.02, I2 = 24%) associated with IFA and MMN and elevated risk of stillbirth (RR: 1.08, 95% CI: 1.00 to 1.17, p = 0.05, I2 = 19%), SGA (RR: 1.03, 95% CI: 0.99 to 1.06) compared to IFA with MMN. However, non-significant risk of PTB (RR: 0.84, 95% CI: 0.38 to 1.84) and MR (RR: 1.04, 95% CI: 0.92 to 1.16, p = 0.54) was observed with IFA as compared to MMN. Neonatal mortality and perinatal mortality also did not significantly differ between the two groups. Certain formulations and doses showed trend of risk, particularly in relation to stillbirth and SGA. CONCLUSIONS: Our findings emphasize the importance of carefully considering the potential risks and benefits of IFA supplementation in pregnancy, and suggest the need for further research to elucidate the underlying mechanisms driving these associations and to optimize supplementation strategies for maternal and neonatal health.

Abstract licence: CC BY-NC-ND

This systematic review, conducted under the COST Action CA20218 "Promoting Innovation of fermented foods" (PIMENTO), aimed to evaluate whether sourdough- and regular-bread fermentation improve iron bioavailability, absorption, and status in humans. Screening of PubMed, Scopus, and Cochrane Library (January 1970-December 2024) identified 8 human intervention studies, in healthy or iron-deficient participants, that met inclusion criteria. EFSA's scientific guidance for health claim applications, which integrates product characteristics and mechanisms of action to the human studies, was followed, and the extracted data were narratively presented. Results were inconclusive as acute postprandial studies increased non-haem iron bioavailability (especially in low-phytate breads); for example, low-phytate white bread produced a greater 2 h increase in serum iron than high-phytate wholemeal bread (59 vs. 30 μg Fe/100 mL), while exogenous phytase increased iron absorption by 50% for ferrous sulfate and 61% for iron bis-glycine chelate. However, long-term trials did not improve, and in one case even decreased, ferritin and total body iron; specifically, in the low-phytate sourdough rye bread group, ferritin declined from 32 ± 7 to 27 ± 6 μg/L and total body iron from 6.9 ± 1.4 to 5.4 ± 1.1 mg/kg over 12 weeks. On the other hand, phytate reduction combined with iron fortification showed positive effects on haemoglobin or prevented iron depletion; in anaemic children, fermented amaranth bread increased haemoglobin [adjusted β = 8.9 g/L (95% CI: 3.5-14.3)] and reduced anaemia prevalence (32% vs. 56%) compared to control bread. Despite convincing mechanistic evidence that the sourdough-fermentation process in bread fabrication improves iron bioavailability, through reduction of phytate, no human studies address this research question with the appropriate control and study quality.Systematic review registrationosf.io/gzt8m.

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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.

Abstract licence: CC BY-NC-ND