Impact of supplementation with iron-folic acid (IFA) and vitamin D3 compared with IFA alone on haemoglobin levels in elderly people with mild-to-moderate anaemia: protocol for the double-blind, randomised, placebo-controlled Iron and vitamin D trial in Elderly Anemia (IDEA).

INTRODUCTION: Anaemia in the elderly is often difficult to treat with iron supplementation alone as prevalence of anaemia of chronic disease (ACD) alone or mixed with iron-deficiency anaemia (IDA) is high in this age group. Hepcidin remains high in ACD, preventing utilisation of iron for heme synthesis. Vitamin D3 has shown hepcidin suppression activity in both in vitro and in vivo studies. As there is no study assessing the effect of iron-folic acid (IFA) with vitamin D3 on haemoglobin levels in the elderly in India, we want to conduct this study to estimate the impact of supplementation of a therapeutic package of IFA and vitamin D3 on haemoglobin levels in the elderly with mild-to-moderate anaemia in comparison with IFA only. The study will also assess the impact of the proposed intervention on ferritin, hepcidin, 25-hydroxyvitamin D, C reactive protein (CRP) and parathyroid hormone (PTH) levels. METHODS AND ANALYSIS: This study is a community-based, double-blind, placebo-controlled, randomised trial. The study will be done in the Kalyani municipality area. Individuals aged ≥60 years with mild-to-moderate anaemia and normal vitamin D3 levels will be randomised into the intervention (IFA and vitamin D3 supplementation) group or the control group (IFA and olive oil as placebo). All medications will be self-administered. Follow-up will be done on a weekly basis for 12 weeks. The calculated sample size is 150 in each arm. Block randomisation will be done. The primary outcome is change in haemoglobin levels from baseline to 12 weeks. Secondary outcome is change in serum ferritin, 25-hydroxyvitamin D, hepcidin, CRP and PTH levels from baseline to 12 weeks. ETHICS AND DISSEMINATION: Ethical approval from the Institutional Ethics Committee of All India Institute of Medical Sciences Kalyani has been obtained (IEC/AIIMS/Kalyani/Meeting/2022/03). Written informed consent will be obtained from each study participant. The trial results will be reported through publication in a reputable journal and disseminated through health talks within the communities. TRIAL REGISTRATION NUMBER: CTRI/2022/05/042775. PROTOCOL VERSION: Version 1.0.

Compliance with iron folic acid (IFA) tablets and associated factors among pregnant women attending ante-natal care clinic at Sub District Hospital, Ballabgarh.

INTRODUCTION: Anemia is a common public health problem among children, adolescent girls, women in reproductive age groups, pregnant and lactating women, with an estimated prevalence of 50.3% among pregnant women according to National Family Health Survey (NFHS) 4. Iron deficiency is regarded as the most common cause of anemia among pregnant women globally and in India. This study was aimed to estimate the prevalence of compliance to iron folic acid (IFA) tablets among pregnant mothers attending ante-natal care (ANC) clinic in a Sub-district hospital (SDH) situated in north India and the various factors associated with non-compliance to IFA tablets. METHODOLOGY: A cross-sectional facility-based study was conducted among pregnant women attending the ANC clinic at SDH, Ballabgarh. A pretested, semi-structured interview schedule was used to obtain socio-demographic data, information related to IFA therapy that they receive, their compliance and the factors that are related to missing of the doses. Data were entered using Epicollect 5 software and Stata version 13.0 was used for statistical analysis. RESULTS: A total of 484 pregnant women were enrolled in our study. More than 3/4th (77.1%) of the pregnant women were compliant to IFA tablet supplement given to them. The compliance was more in the study participants belonging to older age groups, lower socio-economic status and those with hemoglobin levels >11 gm/dl. The most common reason for non-compliance was found to be "forgetfulness" (63.0%) followed by "side effects" (49.5%). CONCLUSION: Compliance with IFA tablets was better among pregnant women who were non anemic and those with good compliance to IFA tablets had better hemoglobin levels.

Comparative analysis of different oral approaches to treat Vibrio cholerae infection in adult mice.

In this study, we have established an oral phage cocktail therapy in adult mice model and also performed a comparative analysis between phage cocktail, antibiotic and oral rehydration treatment for orally developed Vibrio cholerae infection. Four groups of mice were orally infected with Vibrio cholerae MAK 757 strain. Phage cocktail and antibiotic treated groups received 1×10(8) plaque forming unit/ml (once a daily) and 40mg/kg (once a daily) as an oral dose respectively for consecutive three days after bacterial infection. In case of oral rehydration group, the solution was supplied after bacterial infection mixed with the drinking water. To evaluate the better and safer approach of treatment, tissue and serum samples were collected. Here, phage cocktail treated mice reduced the log10 numbers of colony per gram by 3log10 (p<0.05); however, ciprofloxacin treated mice reduced the viable numbers up to 5log10 (p<0.05). Whereas, the oral rehydration solution application was not able to reduce the viable bacterial count but the disease progress was much more diminished (p>0.05). Besides, it was evident that antibiotic and phage cocktail treated group had a gradual decrease in both IL-6 and TNF-α level for 3 days (p<0.05) but the scenario was totally opposite in bacterial control and oral hydration treated group. Histological examinations also endorsed the phage cocktail and ciprofloxacin treatment in mice. Although, in this murine model of cholera ciprofloxacin was found to be a better antimicrobial agent, but from the safety and specificity point of view, a better method of application could fill the bridge and advances the phages as a valuable agent in treating Vibrio cholerae infection.