Prevalence of anemia and associated factors among pregnant women at Hargeisa Group Hospital, Somaliland.

BACKGROUND: Anemia remains a major global public health issue, affecting around 24.8% of the world's population in both developing and developed countries. Pregnant women in developing countries are particularly susceptible, with 38.2% affected worldwide. Anemia is also a major contributor to maternal mortality, with 510,000 maternal deaths globally, of which 20% occur in developing countries and are related to anemia. Iron deficiency anemia is the most prevalent form, impacting 1.3 to 2.2 billion individuals, with 50% being women of reproductive age. AIM: This study aimed to assess the prevalence and associated factors of anemia in pregnant women attending antenatal care (ANC) at Hargeisa Group Hospital (HGH), Somaliland. METHODS: A cross-sectional study included 360 pregnant women, who sought ANC at HGH from July 15 to August 6, 2023. The study subjects were selected using systematic random sampling. Data were collected through structured questionnaires and participants' current medical charts, including hemoglobin levels. Data analysis was performed using SPSS software (version 20). RESULTS: The study revealed an overall prevalence of anemia among pregnant women at 50.6% (95% CI: 45.40 - 55.72%). Anemia severity was categorized as mild (33.0%), moderate (54.9%), and severe (12.1%). Factors statistically associated with anemia included gestational age in the third trimester (AOR = 3.248, 95% CI: 1.491-7.074), lack of ANC visits (AOR = 6.828, 95% CI: 1.966-23.721), and absence of iron supplementation (AOR = 29.588, 95% CI: 2.922-299.713). Notably, a higher consumption of meat per week was associated with a reduced risk of anemia (AOR = 0.198, 95% CI: 0.104-0.379). CONCLUSION: The study underscores the severity of anemia in pregnant women within the range considered as severe public health problem by WHO. It is crucial to emphasize effective prenatal care, improve dietary practices, and promote the provision of iron supplements. Enhanced maternal education on Anemia during ANC visits has the potential to reduce Anemia prevalence and mitigate adverse maternal and neonatal outcomes.

The Importance and Essentiality of Natural and Synthetic Chelators in Medicine: Increased Prospects for the Effective Treatment of Iron Overload and Iron Deficiency.

The supply and control of iron is essential for all cells and vital for many physiological processes. All functions and activities of iron are expressed in conjunction with iron-binding molecules. For example, natural chelators such as transferrin and chelator-iron complexes such as haem play major roles in iron metabolism and human physiology. Similarly, the mainstay treatments of the most common diseases of iron metabolism, namely iron deficiency anaemia and iron overload, involve many iron-chelator complexes and the iron-chelating drugs deferiprone (L1), deferoxamine (DF) and deferasirox. Endogenous chelators such as citric acid and glutathione and exogenous chelators such as ascorbic acid also play important roles in iron metabolism and iron homeostasis. Recent advances in the treatment of iron deficiency anaemia with effective iron complexes such as the ferric iron tri-maltol complex (feraccru or accrufer) and the effective treatment of transfusional iron overload using L1 and L1/DF combinations have decreased associated mortality and morbidity and also improved the quality of life of millions of patients. Many other chelating drugs such as ciclopirox, dexrazoxane and EDTA are used daily by millions of patients in other diseases. Similarly, many other drugs or their metabolites with iron-chelation capacity such as hydroxyurea, tetracyclines, anthracyclines and aspirin, as well as dietary molecules such as gallic acid, caffeic acid, quercetin, ellagic acid, maltol and many other phytochelators, are known to interact with iron and affect iron metabolism and related diseases. Different interactions are also observed in the presence of essential, xenobiotic, diagnostic and theranostic metal ions competing with iron. Clinical trials using L1 in Parkinson's, Alzheimer's and other neurodegenerative diseases, as well as HIV and other infections, cancer, diabetic nephropathy and anaemia of inflammation, highlight the importance of chelation therapy in many other clinical conditions. The proposed use of iron chelators for modulating ferroptosis signifies a new era in the design of new therapeutic chelation strategies in many other diseases. The introduction of artificial intelligence guidance for optimal chelation therapeutic outcomes in personalised medicine is expected to increase further the impact of chelation in medicine, as well as the survival and quality of life of millions of patients with iron metabolic disorders and also other diseases.

Gene expression of iron transporters, markers of vascularization and structural integrity in placenta of mothers with and without anemia.

OBJECTIVE: To compare the mRNA expression of placental iron transporters (TfR-1 and FPN), markers of placental vascularization (VEGF and sFLT1) and marker of structural integrity (LMN-A) in term women with and without iron deficiency anemia. MATERIALS AND METHODS: A total of 30 pregnant women were enrolled; 15 cases of iron deficiency anemia (Hb 7-10.9 gm/dL) and 15 gestational age matched healthy controls (Hb ≥ 11 gm/dL). Peripheral venous blood was collected for assessment of hemoglobin levels and serum iron profile. Placental tissue was used for assessing the mRNA expression of TfR-1, FPN, VEGF, sFLT-1 and LMN-A via real time PCR. RESULTS: Placental expression of TfR-1, VEGF and LMN-A was increased in pregnant women with anemia compared to healthy pregnant controls. Placental expression of sFLT-1 was decreased in pregnant women with anemia compared to healthy pregnant controls. There was no change in the placental expression of FPN. CONCLUSION: The increased expression of TfR-1, VEGF and LMN-A in cases of iron deficiency anemia are most likely to be compensatory in nature to help maintain adequate fetal iron delivery. WHAT DOES THIS STUDY ADDS TO THE CLINICAL WORK: Compensatory changes in the placenta aimed at buffering transport of iron to the fetus are seen in pregnant women with anemia compared to healthy pregnant controls.

Iron Deficiency Related to Obesity.

There is a direct correlation between being overweight and iron deficiency. Physiological changes occur in obese adipose cells that contribute to the development of iron deficiency (ID) and iron deficiency anemia (IDA). These changes disrupt the normal iron metabolic checks and balances. Furthermore, bariatric surgery can lead to long-term ID and IDA. Oral iron supplementation may not be effective for many of these patients. Intravenous iron infusions can significantly increase the quality of life for individuals experiencing this condition but are also associated with potentially serious complications. Adequate knowledge about intravenous (IV) iron administration can greatly increase the safety of this beneficial therapy. This review article explains the relationship between obesity, ID/IDA, bariatric surgery and the safe administration of IV iron.

Factors associated with compliance with weekly iron and folic acid supplementation among school adolescent girls in Debub Achefer district, northwest Ethiopia: school-based cross-sectional study.

Iron deficiency anemia is a public health problem among adolescents that could be addressed by weekly Iron Folic Acid Supplementation (IFAS). The Ethiopian government piloted weekly IFAS in schools, where its effectiveness depends on compliance. We assessed the determinants of compliance with the weekly IFAS in Ethiopia. A school-based survey was conducted in 506 adolescent girls on weekly IFAS. Compliance was considered when girls reported WIFAS for at least three months without discontinuation. Bivariable and multivariable logistic regression models were modeled, with odds ratios reported. Out of 506, 25.8% had limited access to educational resources, and 79.4% had no information on IFAS. Among these, 47.9% (95% CI: 45.5-49.9%) had poor compliance with weekly IFAS. Non-compliance was mainly due to school absenteeism (55.9%). Important predictors of poor compliance were adolescent girls' marital status (AOR = 5.21; 1.55-17.6), academic standing (AOR = 4.37; 2.20-8.70), family income (AOR = 1.85; 1.09-3.15), access to health education materials (AOR = 1.57; 1.02-2.40), problems with IFAS (AOR = 2.44; 1.26-4.74), a discouraging home environment for the program (AOR = 2.27; 1.54-3.34), and a lack of knowledge of the IFAS program (AOR = 1.40; 0.97-2.03). Compliance with weekly IFAS is optimal, which could be improved via strong adherence support and feasible supplementation schedules.

Efficacy and Safety of Oral Supplementation with Liposomal Iron in Non-Dialysis Chronic Kidney Disease Patients with Iron Deficiency.

INTRODUCTION: Iron deficiency is common in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). Oral iron supplementation is recommended in these patients, but it is associated with a higher incidence of gastrointestinal adverse reactions. Liposomal iron therapy has been proposed as a new iron formulation, improving iron bioavailability with less side effects; however, few data are available in patients with NDD-CKD. METHODS: We designed a single-arm pilot study to evaluate the efficacy of liposomal iron administered for six months in correcting iron deficiency (defined as serum ferritin < 100 ng/mL and/or transferrin saturation < 20%) in patients with NDD-CKD stages 1-5. The primary endpoints were the achievement of serum ferritin ≥ 100 ng/mL and transferrin saturation ≥ 20%. Secondary outcomes were hemoglobin (Hb) changes and the safety of liposomal iron. RESULTS: The efficacy population included 34/38 patients, who completed at least one visit after baseline. Liposomal iron increased the achievement of transferrin saturation targets from 11.8% at baseline to 50.0% at month 6 (p = 0.002), while no significant correction of serum ferritin (p = 0.214) and Hb was found (p = 0.465). When patients were stratified by anemia (Hb < 12 g/dL in women and Hb < 13 g/dL in men), a significant improvement of transferrin saturation was observed only in anemic patients (from 13.3 ± 5.8% to 20.2 ± 8.1%, p = 0.012). Hb values slightly increased at month 6 only in anemic patients (+0.60 g/dL, 95%CI -0.27 to +1.48), but not in those without anemia (+0.08 g/dL, 95%CI -0.73 to +0.88). In patients taking at least one dose of liposomal iron (safety population, n = 38), the study drug was discontinued in eight patients due to death (n = 2), a switch to intravenous iron (n = 2), and the occurrence of side effects (n = 4). CONCLUSIONS: The use of liposomal iron in patients with NDD-CKD is associated with a partial correction of transferrin saturation, with no significant effect on iron storage and Hb levels.

Anemia in Breastfeeding Women and Its Impact on Offspring's Health in Indonesia: A Narrative Review.

Anemia in breastfeeding women is a neglected global health issue with significant implications for maternal and child health. Despite its widespread occurrence and adverse effects, this problem remains largely unknown and overlooked on the global health agenda. Despite efforts to improve health access coverage and provide iron and folic acid supplementation, anemia persists. This underscores the need for a comprehensive approach to address the problem. Urgent action must be taken to prioritize education and awareness campaigns, ensure access to nutritious food, and enhance healthcare services. Education programs should focus on promoting iron-rich diets, dispelling cultural myths, and providing practical guidance. Improving healthcare services requires increasing availability, ensuring a consistent supply of iron supplements, and providing adequate training for healthcare providers. A successful implementation relies on a strong collaboration between the government, healthcare providers, and community. It is crucial that we acknowledge that high coverage alone is insufficient for solving the issue, emphasizing the importance of targeted interventions and a strategic implementation. By adopting a comprehensive approach and addressing the underlying causes of anemia, Indonesia can make significant progress in reducing its prevalence and improving the overall health of its population, particularly among breastfeeding women.

The findings of a service evaluation on the practice of assessment and treatment of iron deficiency in people admitted to a UK hospital with decompensated Heart Failure.

BACKGROUND: Iron Deficiency (ID) is common in Heart Failure (HF) and associated with poor outcomes. Replacement with intravenous (IV) iron can improve functional status, quality of life and risk of unplanned admission. In 2015/16 a local service evaluation was performed which found that of people admitted with HF, only 27.5 % had assessment of iron status, and when identified, replacement occurred in fewer than half. Education strategies were employed to increase awareness of the importance of assessment and correction. OBJECTIVES: To assess if practice had improved following education strategies. METHODS: A review of 220 patient records for people admitted with HF in 2020/21 to establish if iron status assessed, presence of ID, and whether if ID identified it was treated, and by which route. Trends in 2020/21 data were explored in sub-groups by age, sex, type of HF, anaemia status, input from HF specialists and type of ID. RESULTS: Compared to 2015/16, more assessments of iron status were performed (45% vs 27.5 %), ID was corrected more frequently (57% vs 46 %) and increased use of the IV route for replacement (83% vs 58 %) CONCLUSIONS: Despite the impact of COVID-19 on usual care in 2020/21, improvement was seen in proportion of assessment and treatment of ID following simple education strategies for key stakeholders. There may be scope to improve practice further if the findings remain similar post pandemic. If so, a formal Quality Improvement approach may be helpful.

Association between low MCV in early pregnancy and perinatal mental health in the Japan Environment and Children's Study and the possible effect of iron deficiency.

BACKGROUND: Postpartum anemia and iron deficiency are associated with postpartum depression. This study investigated the association between a low mean corpuscular volume (MCV) without anemia (which implies early-stage iron deficiency) in early pregnancy and perinatal mental health outcomes. METHODS: The fixed data from the Japan Environment and Children's Study (JECS), a Japanese nationwide birth cohort, were used. Perinatal mental health was assessed using the Kessler 6-item psychological distress scale (K6) in mid-pregnancy and the Edinburgh Postnatal Depression Scale (EPDS) at 1- and 6-months postpartum. RESULTS: Among the 3635 women with MCVs <85 fL in early pregnancy, the proportions of women with K6 scores ≥13 in mid-pregnancy and EPDS scores ≥9 at 1- and 6-months postpartum were 2.7 %, 12.8 %, and 9.9 %, respectively, compared with the 33,242 women with MCVs ≥85 fL at 1.9 %, 11.9 %, and 9.0 %, respectively. Multivariate logistic regression models showed that an MCV <85 in early pregnancy was associated with a K6 score ≥ 13 in mid-pregnancy and an EPDS score ≥ 9 at 1- and 6-months postpartum (adjusted odds ratio (95 % confidence interval): 1.48 (1.16-1.87), 1.14 (1.01-1.28), and 1.09 (0.95-1.24), respectively). LIMITATIONS: Low MCV values do not necessarily represent iron deficiency. Ferritin, currently the best indicator of iron deficiency, was not measured in the JECS. CONCLUSIONS: This study results suggest that a low MCV without anemia in early pregnancy is associated with a slightly increased risk of perinatal mental health deterioration.

Imbalance of Iron Availability and Demand in Patients With Acute and Chronic Heart Failure.

BACKGROUND: Iron deficiency (ID) is a frequent comorbidity in patients with acute (AHF) and chronic heart failure (CHF) associated with morbidity and death. We aimed to better characterize iron homeostasis in patients with heart failure applying different biomarkers and to evaluate the accuracy of current ID definition by the European Society of Cardiology/American College of Cardiology/American Heart Association to indicate tissue iron availability and demand. METHODS AND RESULTS: We performed a retrospective cohort study investigating 277 patients with AHF and 476 patients with CHF between February 2021 and May 2022. Patients with AHF had more advanced ID than patients with CHF, reflected by increased soluble transferrin receptor and soluble transferrin receptor-ferritin index, and lower ferritin, serum iron, transferrin saturation, hepcidin, and reticulocyte hemoglobin. Decreased iron availability or increased tissue iron demand, reflected by increased soluble transferrin receptor-ferritin index and decreased reticulocyte hemoglobin, was found in 84.1% (AHF) and 28.0% (CHF) with absolute ID and in 50.0% (AHF) and 10.5% (CHF) with combined ID according to the current European Society of Cardiology/American College of Cardiology/American Heart Association-based ID definition. Low hepcidin expression as an indicator of systemic ID was found in 91.1% (AHF) and 80.4% (CHF) of patients with absolute ID and in 32.3% (AHF) and 18.8% (CHF) of patients with combined ID. ID definitions with higher specificity reduce the need for iron supplementation by 25.5% in patients with AHF and by 65.6% in patients with CHF. CONCLUSIONS: Our results suggest that the current European Society of Cardiology/American College of Cardiology/American Heart Association-based ID definition might overestimate true ID, particularly in CHF. More stringent thresholds for ID could more accurately identify patients with heart failure with reduced tissue iron availability who benefit from intravenous iron supplementation.

Norma Técnica de Salud: Prevención y control de la anemia por deficiencia de hierro en el niño y la niña, adolescentes, mujeres en edad fértil, gestantes y puérperas. NTS N° 213-MINSA/DGIESP-2024 / Technical Health Standard: Prevention and control of iron deficiency anemia in boys and girls, adolescents, women of childbearing age, pregnant women and postpartum women. NTS N° 213-MINSA/DGIESP-2024

La norma técnica contiene las disposiciones técnicas y administrativas para las intervenciones del sistema de salud para la prevención y control de la anemia por deficiencia de hierro en la niña y el niño, adolescentes, mujeres en edad fértil, gestantes y puérperas.

Health information technology tools to accelerate gastrointestinal evaluation in patients with iron deficiency anaemia: a cluster randomised controlled trial.

OBJECTIVE: System-level safety measures do not exist to ensure that patients with iron deficiency anaemia (IDA) undergo proper diagnostic evaluations. We sought to determine if a set of EHR (electronic health record) tools and an expedited referral workflow increase short-term completion of bidirectional endoscopy in higher risk patients with IDA. MATERIALS AND METHODS: We conducted a pragmatic, cluster-randomised trial randomised by primary care physician (PCP) that included 16 PCPs and 316 patients with IDA. Physicians were randomised to intervention or control groups. Intervention components included a patient registry visible within the EHR, point-of-care alert and expedited diagnostic evaluation workflow for IDA. Outcomes were assessed at 120 days. The primary outcome was completion of bidirectional endoscopy. Secondary outcomes were any endoscopy completed or scheduled, gastroenterology consultation completed, and gastroenterology referral or endoscopy ordered or completed. RESULTS: There were no differences in the primary or secondary outcomes. At 120 days, the primary outcome had occurred for 7 (4%) of the intervention group and 5 (3.5%) of the control group. For the three secondary outcomes, rates were 15 (8.6%), 12 (6.9%) and 39 (22.4%) for the immediate intervention group and 10 (7.0%), 9 (6.3%) and 25 (17.6%) for the control group, respectively, p>0.2. Lack of physician time to use the registry tools was identified as a barrier. DISCUSSION AND CONCLUSION: Providing PCPs with lists of patients with IDA and a pathway for expedited evaluation did not increase rates of completing endoscopic evaluation in the short term. TRIAL REGISTRATION NUMBER: NCT05365308.

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.

Epidemiology of Celiac Disease in Western Iran during 2019-2021.

Celiac disease is a growing global public health concern. This epidemiological study is aimed at determining the prevalence of celiac disease in Kermanshah, Western Iran, from 2019 to 2021, as well as the frequency of gastrointestinal and nongastrointestinal manifestations associated with the disease. In this cross-sectional study, the medical records of all patients with a confirmed diagnosis of celiac disease between 2019 and 2021 were reviewed. The average population during the study period was 2,058,545. A researcher-developed checklist was used as the data collection tool, and descriptive statistics were employed for data analysis. During the study period, there were 113 patients diagnosed with celiac disease, with a mean age of 29.1 ± 16.6 years. The three-year prevalence of celiac disease was 5.49 (95% CI: 5.17-5.82) per 100,000 population. Among these patients, 70% (n = 78) was female. The most common gastrointestinal manifestations of the disease were abdominal pain (77.8%), constipation (59.3%), and diarrhea (54.9%). Iron-deficiency anemia (64.6%) and vitamin D3 deficiency (46.1%) were the most common nongastrointestinal manifestations. Growth retardation was observed in 39.0% of patients. This study demonstrated a higher prevalence of celiac disease in Kermanshah compared to global statistics. Given the association of celiac disease with other conditions such as diabetes, irritable bowel syndrome, growth retardation, and iron-deficiency anemia, healthcare providers should consider screening patients for celiac disease. Furthermore, community-based education is crucial in raising awareness about the significance of adhering to a proper diet and reducing wheat consumption.

Prevalence and predictors of iron deficiency anaemia among children with sickle cell disease in Dodoma, Tanzania: a cross-sectional study.

BACKGROUND: Patients with sickle cell disease (SCD) are prone to iron profile derangements. This study aimed to determine the prevalence of iron deficiency anaemia (IDA) and their predictors among children with SCD aged between 6 months and 14 years. Assessment of the prevalence of IDA and its predictors helps to understand ways of alleviating the magnitude of the problem so as to prevent possible complications such as shortness of breath and chest pain. METHODS: This was a cross-sectional analytical hospital-based study which included 174 patients with SCD attending SCD clinics at St. Gema hospital and Dodoma regional referral hospital in Dodoma city from October 2020 to March 2021. The cut-off points for detection of IDA was serum ferritin level < 30 µg/L and low mean corpuscular volume (MCV) for age. Data were analyzed using SPSS software version 25.0. Multivariate logistic regression analysis was used to determine the predictors of IDA. P-value less than 0.05 was considered significant. RESULTS: The prevalence of IDA in this study was (16.1%, n = 28). Family income of less than 70,000/= TZS/month (AOR = 2.2, 95% CI = 1.07-2.49, p = 0.023), being transfused with blood less than 3 times from the time of being diagnosed with SCD (AOR = 5.5, 95% CI = 1.03-8.91, p = 0.046), and eating red meat at least once per month (AOR = 3.60, 95% CI = 1.37-9.46, p = 0.010) remained the independent predictors of IDA in multivariate regression analysis. CONCLUSION: The findings of this study have shown that, support of families with children suffering from SCD in terms of financial support for improving medical services including optimal blood transfusion and affordability of diet which is rich in iron such as red meat is imperative.

Iron Supplementation of Pregnant Sows to Prevent Iron Deficiency Anemia in Piglets: A Procedure of Questionable Effectiveness.

In pigs, iron deficiency anemia (IDA) is a common disorder that occurs during the early postnatal period, leading to the stunted growth and increased mortality of piglets. The main cause of IDA is low iron stores in the liver of newborn piglets; these stores constitute the main source of iron needed to satisfy the erythropoietic requirements of the piglets in their first weeks of life. Insufficient iron stores in piglets are usually due to the inadequate placental iron transfer from the sow to the fetuses. Therefore, iron supplementation in pregnant sows has been implemented to enhance placental iron transfer and increase iron accumulation in the liver of the fetuses. Over the years, several oral and parenteral approaches have been attempted to supplement sows with various iron preparations, and consequently, to improve piglets' red blood cell indices. However, there is debate with regard to the effectiveness of iron supplementation in pregnant sows for preventing IDA in newborn piglets. Importantly, this procedure should be carried out with caution to avoid iron over-supplementation, which can lead to iron toxicity. This article aims to critically review and evaluate the use of iron supplementation in pregnant sows as a procedure for preventing IDA in piglets.

Haem iron versus ferrous iron salts to treat iron deficiency anaemia in Gambian children: protocol for randomised controlled trial {1}.

BACKGROUND: The World Health Organization recommends universal iron supplementation for children aged 6-23 months in countries where anaemia is seen in over 40% of the population. Conventional ferrous salts have low efficacy due to low oral absorption in children with inflammation. Haem iron is more bioavailable, and its absorption may not be decreased by inflammation. This study aims to compare daily supplementation with haem iron versus ferrous sulphate on haemoglobin concentration and serum ferritin concentration after 12 weeks of supplementation. METHODS: This will be a two-arm, randomised controlled trial. Gambian children aged 6-12 months with anaemia will be recruited within a predefined geographical area and recruited by trained field workers. Eligible participants will be individually randomised using a 1:1 ratio within permuted blocks to daily supplementation for 12 weeks with either 10.0 mg of elemental iron as haem or ferrous sulphate. Safety outcomes such as diarrhoea and infection-related adverse events will be assessed daily by the clinical team (see Bah et al. Additional file 4_Adverse event eCRF). Linear regression will be used to analyse continuous outcomes, with log transformation to normalise residuals as needed. Binary outcomes will be analysed by binomial regression or logistic regression, Primary analysis will be by modified intention-to-treat (i.e., those randomised and who ingested at least one supplement dose of iron), with multiple imputations to replace missing data. Effect estimates will be adjusted for baseline covariates (C-reactive protein, alpha-1-acid glycoprotein, haemoglobin, ferritin, soluble transferrin receptor). DISCUSSION: This study will determine if therapeutic supplementation with haem iron is more efficacious than with conventional ferrous sulphate in enhancing haemoglobin and ferritin concentrations in anaemic children aged 6-12 months. TRIAL REGISTRATION: Pan African Clinical Trial Registry PACTR202210523178727.