Validation and verification framework and data integration of biosensors and in vitro diagnostic devices: a position statement of the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MBHLM) and the IFCC Scientific Division.

Advances in technology have transformed healthcare and laboratory medicine. Biosensors have emerged as a promising technology in healthcare, providing a way to monitor human physiological parameters in a continuous, real-time, and non-intrusive manner and offering value and benefits in a wide range of applications. This position statement aims to present the current situation around biosensors, their perspectives and importantly the need to set the framework for their validation and safe use. The development of a qualification framework for biosensors should be conceptually adopted and extended to cover digitally measured biomarkers from biosensors for advancing healthcare and achieving more individualized patient management and better patient outcome.

External quality assessment practices in medical laboratories: an IFCC global survey of member societies.

OBJECTIVES: Clinical laboratory results are required for critical medical decisions, underscoring the importance of quality results. As part of total quality management, external quality assessment (EQA) is a vital component to ensure laboratory accuracy. The goal of this survey was to evaluate the current status of global laboratory quality systems and assess the need for implementation, expansion, or harmonization of EQA programs (EQAP) for Clinical Chemistry and Laboratory Medicine. METHODS: The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC full and affiliate members (n=110) on laboratory quality practice. A total of 41 (37.3%) countries representing all IFCC regions except North America provided responses about EQA availability and practices. RESULTS: All 41 countries perform EQA, 38 reported that their laboratories had EQA policies and procedures, and 39 further act/evaluate unacceptable EQA results. 39 countries indicated they have international and/or national EQAP and 30 use alternative performance assessments. EQA frequency varied among countries. Generally, an EQAP provided the EQA materials (40/41) with four countries indicating that they did not have an EQAP in their country. CONCLUSIONS: Globally, most laboratories participate in an EQAP and have defined quality procedures for EQA. There remain gaps in EQA material availability and implementation of EQA as a part of a total laboratory quality system. This survey highlights the need for education, training, and harmonization and will guide efforts of the IFCC TF-GLQ in identifying areas for enhancing global laboratory quality practices.

Quality standards and internal quality control practices in medical laboratories: an IFCC global survey of member societies.

OBJECTIVES: The trueness and precision of clinical laboratory results are ensured through total quality management systems (TQM), which primarily include internal quality control (IQC) practices. However, quality practices vary globally. To understand the current global state of IQC practice and IQC management in relation to TQM the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Task Force on Global Laboratory Quality (TF-GLQ) conducted a survey of IFCC member countries on IQC practices and management. METHODS: The survey included 16 questions regarding IQC and laboratory TQM practices and was distributed to IFCC full and affiliate member countries (n=110). A total of 46 (41.8 %) responses were received from all regions except North America. RESULTS: Of the responding countries, 78.3 % (n=36) had legislative regulations or accreditation requirements governing medical laboratory quality standards. However, implementation was not mandatory in 46.7 % (n=21) of responding countries. IQC practices varied considerably with 57.1 % (n=28) of respondents indicating that they run 2 levels of IQC, 66.7 % (n=24) indicating they run IQC every 24 h and 66.7 % (n=28) using assay manufacturer IQC material sources. Only 29.3 % (n=12) of respondents indicated that every medical laboratory in their country has written IQC policies and procedures. By contrast, 97.6 % (n=40) of responding countries indicated they take corrective action and result remediation in the event of IQC failure. CONCLUSIONS: The variability in TQM and IQC practices highlights the need for more formal programs and education to standardize and improve TQM in medical laboratories.

Daily v. weekly oral vitamin D3 therapy for nutritional rickets in Indian children: a randomised controlled open-label trial.

The aim of the study was to compare the efficacy of daily v. weekly oral vitamin D3 therapy in radiological healing of nutritional rickets. Children 6 months to 12 years (n 132) diagnosed with nutritional rickets were randomised into three groups (n 44): group A - 2000 IU daily vitamin D3 for 12 weeks, B - 60 000 IU weekly for 3 weeks, C - 60 000 IU weekly for 6 weeks. Serum calcium, phosphorus, 25-hydroxyvitamin D (25(OH)D), parathyroid hormone and X-ray score were estimated at baseline and 12 weeks (endline). The proportion of children who achieved complete radiological healing at endline was compared between three groups by χ2 and delta change in laboratory parameters by ANOVA (parametric data) or Kruskal Wallis test (non-parametric data), respectively. Baseline 25(OH)D ≤ 20 ng/ml was seen in 119 (90·2 %), hyperparathyroidism in 90 (68·8 %) and hypocalcaemia in 96 (72·7 %). A total of 120/132 children completed the study. Complete radiological healing seen in 30 (75 %) in group A, 23 (60·5 %) in group B and 26 (61·9 %) in group C; P = 0·15, with comparable endline X-ray scores; P = 0·31. The median (interquartile range (IQR)) delta X-ray score (baseline-endline) was 7 (4,9), 5 (2·25, 6) and 6 (4,7) in groups A, B and C, respectively; P = 0·019. Median (IQR) 25(OH)D endline levels in groups A, B and C were 50·0 (26·5, 66·5), 42·1 (28·4, 54·4) and 53·5 (33·7, 71·2) ng/ml, respectively; P = 0·045. Radiological scores were comparable at endline among daily and weekly vitamin D groups with greater change from baseline in daily supplemented group.

Target association rule mining to explore novel paediatric illness patterns in emergency settings.

BACKGROUND AND AIMS: To assess the hospitalized sick children admitted to the pediatric emergency department (ED) and to find new patterns of clinical and laboratory attributes using association rule mining (ARM). METHODS: In this observational study, 158 children with median (IQR) age 11 months and a PRISM III score of 5 (2-9) were enrolled. Hotspot data mining method was applied to assess clinical attributes, lab investigations and pre-defined outcome parameters of children and their association in sick hospitalized children aged 1 month to 12 years. RESULTS: We obtained 30 rules with value for outcome as discharge is given attributes as follows: duration of hospitalization > 4 days, lactate > 1.2 mmol/L, platelet = 3.67/µL, dur_ventil = 0 h, serum K = 5.2 mmol/L, SBP = 120 mmHg, pCO2 = 41.9 mmHg, PaO2 = 163 mmHg, age = 92 months, heart rate > 114-159 per minute, temperature > 98 °F, GCS (Glasgow Coma Scale) > 7-14, gas K = 4.14 mmol/L, gas Na = 138.1 mmol/L, BUN (Blood Urea Nitrogen) = 18.69 mg/dL, Diagnosis > 1-718, Creatinine = 1.2 mg/dL, serum Na = 148 mmol/L, shock = 2, Glucose = 144 mg/dL, Mg(i) > 0.23 meq/L, BUN > 6.54 mg/dL. CONCLUSION: ARM is an effective data analysis technique to find meaningful patterns using clinical features with actual numbers in pediatric critical illness. It can prove to be important while analysing the association of clinical attributes with disease pattern, its features, and therapeutic or intervention success patterns.

Ionized Blood Magnesium in Sick Children: An Overlooked Electrolyte.

INTRODUCTION: Magnesium is a less frequently monitored electrolyte in critically ill patients. Hypomagnesemia is associated with increased need for mechanical ventilation, mortality and prolonged ICU stay. The present study was undertaken to identify the proportion of children with abnormal magnesium levels and correlate it with disease outcome. METHODS: This observational study included children aged 1 month to 12 years hospitalized at the emergency room. Heparinized blood was collected for determination of ionized magnesium, ionized calcium, sodium, potassium and lactate using Stat Profile Prime Plus (Nova Biomedical, Waltham, MA, USA). Clinical outcomes for duration of hospitalization, and death or discharge were recorded. RESULTS: A total of 154 (102 males) children with median (IQR) age of 11 (4, 49.75) months were enrolled. Sixty one (39.6%) had ionized magnesium levels below 0.42 mmol/l, 63 (40.9%) had normal levels and 30 (19.4%) had hypermagnesemia (>0.59 mmol/l). Hypomagnesemia was associated with hypocalcemia (p < 0.001), hyponatremia (p < 0.001) and hypokalemia (p < 0.02). A higher proportion of children with hypermagnesemia required ventilation than hypomagnesemia (26% vs. 9%) and succumbed (35% vs. 20%), respectively; p > 0.05. Ninety-three (60.3%) had hypocalcemia and 10 (6.5%) children had hypercalcemia. There was good correlation between ionized calcium and magnesium values (r = 0.72, p < 0.001). CONCLUSION: Both hypomagnesemia and hypermagnesemia were seen in critically ill children. Patients with hypomagnesemia had significantly higher proportion of other electrolyte abnormalities.

Assessment of Nutritional Status of Patients of Congenital Pouch Colon Following Definitive Surgery.

PURPOSE: To assess the nutritional status in 31 patients of congenital pouch colon (CPC) who had undergone definitive surgery and closure of a protective stoma, if any, at least 1 year earlier and were below 14 years age. MATERIALS AND METHODS: The clinical history, demographic details, anthropometric measurements, and results of hematological and biochemical tests were recorded. In addition to collective data, analysis was also performed after grouping by age, subtype of CPC (Types I/II and Types III/IV CPC), and in Types I/II CPC patients, by whether the colonic pouch had been completely excised or else a segment preserved by tubular colorraphy (TC). RESULTS: Severe fecal incontinence (FI) was common (64.52%). Anthropometry showed a significant malnutrition in 53.85-95.45% patients, especially stunting which was most prevalent in the 0-5 years age-group. Serum Vitamin B12, folate, and Vitamin D were lower than normal in 38.71%, 22.58%, and 74.19% patients, respectively, without statistically significant difference among the various groups studied. Patients with Types I/II CPC had a statistically significant higher incidence of anemia, low serum ferritin, and severe FI than patients with Types III/IV CPC. Patients with Types I/II CPC, managed by excision of the colonic pouch, had a higher incidence of severe FI, wasting, and thinness than those undergoing TC. CONCLUSIONS: On follow-up of the patients of CPC, anthropometry shows a high incidence of malnutrition, especially stunting in the 0-5 years age-group. There is an adequate adaptation of fluid-electrolyte homeostasis. Although Types I/II CPC patients have a significantly higher incidence of anemia and severe FI than Types III/IV CPC patients, long-term anthropometric parameters are similar. In Types I/II CPC, preservation of the colonic pouch by TC offers long-term benefit.

The Role of 25-Hydroxy Vitamin D Deficiency in Iron Deficient Children of North India.

Extensive data from animal and human studies indicate a role of vitamin D in erythropoiesis. Iron and vitamin D deficiencies are implicated with adverse health effects in children even if they are asymptomatic. The potential relationship between the two remains poorly understood. A cross-sectional study was performed in the period from 1st May 2012 through 30th April 2013 and subjects were classified into vitamin D deficiency (VDD), vitamin D insufficiency (VDI) and vitamin D sufficiency (VDS) groups according to their 25(OH) D levels. A total of 263 children were included in the analysis. Anaemia was present in 66 % of 25(OH) D deficient subjects compared with 35 % in vitamin D sufficient individuals (p < 0.0001). The association of breast feeding and development of VDD was also significant (p < 0.05). Serum levels of 25(OH) D were found lower in female sex and if the analysis was performed in the winter/spring season. Physicians should therefore assess vitamin D levels in all anaemic children and ensure adequate supplementation to prevent deficiencies.

Unlocking new potential of clinical diagnosis with artificial intelligence: Finding new patterns of clinical and lab data.

Recent advancements in science and technology, coupled with the proliferation of data, have also urged laboratory medicine to integrate with the era of artificial intelligence (AI) and machine learning (ML). In the current practices of evidence-based medicine, the laboratory tests analysing disease patterns through the association rule mining (ARM) have emerged as a modern tool for the risk assessment and the disease stratification, with the potential to reduce cardio-vascular disease (CVD) mortality. CVDs are the well recognised leading global cause of mortality with the higher fatality rates in the Indian population due to associated factors like hypertension, diabetes, and lifestyle choices. AI-driven algorithms have offered deep insights in this field while addressing various challenges such as healthcare systems grappling with the physician shortages. Personalized medicine, well driven by the big data necessitates the integration of ML techniques and high-quality electronic health records to direct the meaningful outcome. These technological advancements enhance the computational analyses for both research and clinical practice. ARM plays a pivotal role by uncovering meaningful relationships within databases, aiding in patient survival prediction and risk factor identification. AI potential in laboratory medicine is vast and it must be cautiously integrated while considering potential ethical, legal, and pri-vacy concerns. Thus, an AI ethics framework is essential to guide its responsible use. Aligning AI algorithms with existing lab practices, promoting education among healthcare professionals, and fostering careful integration into clinical settings are imperative for harnessing the benefits of this transformative technology.

Insights on antioxidant therapeutic strategies in type 2 diabetes mellitus: A narrative review of randomized control trials.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a metabolic disease of impaired glucose utilization. Imbalance in generation and elimination of free radicals generate oxidative stress which modulates glucose metabolism and insulin regulation, resulting in the occurrence and progression of diabetes and associated complications. Antioxidant supplements in T2DM can be seen as a potential preventive and effective therapeutic strategy. AIM: To compare randomized controlled trials (RCTs) in which antioxidants have been shown to have a therapeutic effect in T2DM patients. METHODS: We systematically searched the electronic database PubMed by keywords. RCTs evaluating the effect of antioxidant therapy on glycaemic control as well as oxidant and antioxidant status as primary outcomes were included. The outcomes considered were: A reduction in blood glucose; changes in oxidative stress and antioxidant markers. Full-length papers of the shortlisted articles were assessed for the eligibility criteria and 17 RCTs were included. RESULTS: The administration of fixed-dose antioxidants significantly reduces fasting blood sugar and glycated hemoglobin and is associated with decreased malondialdehyde, advanced oxidation protein products, and increased total antioxidant capacity. CONCLUSION: Antioxidant supplements can be a beneficial approach for the treatment of T2DM.

Comparative analysis of Nε-carboxymethyl-lysine and inflammatory markers in diabetic and non-diabetic coronary artery disease patients.

BACKGROUND: Coronary artery disease (CAD) is a major cause of death worldwide, and India contributes to about one-fifth of total CAD deaths. The development of CAD has been linked to the accumulation of Nε-carboxymethyl-lysine (CML) in heart muscle, which correlates with fibrosis. AIM: To assess the impact of CML and inflammatory markers on the biochemical and cardiovascular characteristics of CAD patients with and without diabetes. METHODS: We enrolled 200 consecutive CAD patients who were undergoing coronary angiography and categorized them into two groups based on their serum glycosylated hemoglobin (HbA1c) levels (group I: HbA1c ≥ 6.5; group II: HbA1c < 6.5). We analyzed the levels of lipoproteins, plasma HbA1c levels, CML, interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and nitric oxide. RESULTS: Group I (81 males and 19 females) patients had a mean age of 54.2 ± 10.2 years, with a mean diabetes duration of 4.9 ± 2.2 years. Group II (89 males and 11 females) patients had a mean age of 53.2 ± 10.3 years. Group I had more severe CAD, with a higher percentage of patients with single vessel disease and greater stenosis severity in the left anterior descending coronary artery compared to group II. Group I also exhibited a larger left atrium diameter. Group I patients exhibited significantly higher levels of CML, TNF-α, and IL-6 and lower levels of nitric oxide as compared with group II patients. Additionally, CML showed a significant positive correlation with IL-6 (r = 0.596, P = 0.001) and TNF-α (r = 0.337, P = 0.001) and a negative correlation with nitric oxide (r=-4.16, P = 0.001). Odds ratio analysis revealed that patients with CML in the third quartile (264.43-364.31 ng/mL) were significantly associated with diabetic CAD at unadjusted and adjusted levels with covariates. CONCLUSION: CML and inflammatory markers may play a significant role in the development of CAD, particularly in diabetic individuals, and may serve as potential biomarkers for the prediction of CAD in both diabetic and non-diabetic patients.

Left atrial function by two-dimensional speckle tracking echocardiography in patients with severe rheumatic mitral stenosis and pulmonary hypertension.

We studied left atrial (LA) function in severe rheumatic mitral stenosis (MS) patients using two-dimensional speckle tracking echocardiography (STE). Eighty patients with isolated severe MS in sinus rhythm and 40 controls underwent comprehensive echocardiography including STE derived LA strain [reservoir strain (LASr), conduit strain (LAScd) and contractile strain (LASct)]. The mean MVA was 0.93 ± 0.21 cm2. The mean values of LASr (14.73 ± 8.59%), LAScd (-7.61 ± 4.47%) and LASct (-7.16 ± 5.15%) in patients were significantly lower (p < 0.001) vs. controls 44.11 ± 10.44%, -32.45 ± 7.63%, -11.85 ± 6.77% respectively and showed decreasing trend with increasing MS severity and higher NYHA class. In conclusion, LA dysfunction is prevalent in severe MS irrespective of NYHA functional class.

Gender differences in genotypic distribution of endothelin-1 gene and endothelin receptor A gene in pulmonary hypertension associated with rheumatic mitral valve disease.

INTRODUCTION: The female gender is a risk factor for idiopathic pulmonary arterial hypertension. However, it is unknown whether females with rheumatic mitral valve disease are more predisposed to develop pulmonary hypertension compared to males. AIM: We aimed to investigate whether there was a difference in genotypic distribution of endothelin-1 (ET-1) and endothelin receptor A (ETA) genes between female and male patients of pulmonary hypertension associated with rheumatic mitral valve disease (PH-MVD). METHODS: We compared prevalence of ET-1 gene (Lys198Asn) and ETA gene (His323His) polymorphisms according to gender in 123 PH-MVD subjects and 123 healthy controls. RESULTS: The presence of mutant Asn/Asn and either mutant Asn/Asn or heterozygous Lys/Asn genotypes of Lys198Asn polymorphism when compared to Lys/Lys in females showed significant association with higher risk (odds ratio [OR] 4.5; p =0.007 and OR 2.39; p =0.02, respectively). The presence of heterozygous C/T and either mutant T/T or heterozygous C/T genotypes of His323His polymorphism when compared to wild C/C genotype in females showed a significant association with higher risk (OR 1.96; p =0.047 and OR 2.26; p =0.01, respectively). No significant difference was seen in genotypic frequencies in males between PH-MVD subjects and controls. Logistic regression analysis showed that mutant genotype Asn/Asn (p =0.007) and heterozygous genotype Lys/Asn of Lys198Asn polymorphism (p =0.018) were independent predictors of development of PH in females. CONCLUSIONS: ET-1 and ETA gene polymorphisms were more prevalent in females than males in PH-MVD signifying that females with rheumatic heart disease may be more susceptible to develop PH.

Lessons Learned from the COVID-19 Pandemic: Emphasizing the Emerging Role and Perspectives from Artificial Intelligence, Mobile Health, and Digital Laboratory Medicine.

SARS-CoV-2, the new coronavirus causing COVID-19, is one of the most contagious disease of past decades. COVID-19 is different only in that everyone is encountering it for the first time during this pandemic. The world has gone from complete ignorance to a blitz of details in a matter of months. The foremost challenge that the scientific community faces is to understand the growth and transmission capability of the virus. As the world grapples with the global pandemic, people are spending more time than ever before living and working in the digital milieu, and the adoption of Artificial Intelligence (AI) is propelled to an unprecedented level especially as AI has already proven to play an important role in counteracting COVID-19. AI and Data Science are rapidly becoming important tools in clinical research, precision medicine, biomedical discovery and medical diagnostics. Machine learning (ML) and their subsets, such as deep learning, are also referred to as cognitive computing due to their foundational basis and relationship to cognition. To date, AI based techniques are helping epidemiologists in projecting the spread of virus, contact tracing, early detection, monitoring, social distancing, compiling data and training of healthcare workers. Beside AI, the use of telemedicine, mobile health or mHealth and the Internet of Things (IOT) is also emerging. These techniques have proven to be powerful tools in fighting against the pandemic because they provide strong support in pandemic prevention and control. The present study highlights applications and evaluations of these technologies, practices, and health delivery services as well as regulatory and ethical challenges regarding AI/ML-based medical products.

Point of Care Testing of Serum Electrolytes and Lactate in Sick Children.

OBJECTIVE: To evaluate the electrolyte and lactate abnormalities in hospitalized children using a point of care testing (POCT) device and assess the agreement on the electrolyte abnormalities between POCT and central laboratory analyzer with venous blood. METHODS: This observational study recruited hospitalized children aged 1 month to 12 years within two hours of admission. A paired venous sample and heparinized blood sample were drawn and analyzed by the central laboratory and POCT device (Stat Profile Prime Plus-Nova Biomedical, Waltham, MA, USA) for sodium and potassium. Lactate was measured on the POCT device only. The clinical and outcome parameters of children with electrolyte abnormalities or elevated lactate (>2mmol/L), and the agreement between POCT values and central laboratory values were assessed. RESULTS: A total of 158 children with median (IQR) age 11 (6-10) months and PRISM score 5 (2-9) were enrolled. The proportion of children with abnormal sodium and potassium levels, and acidosis on POCT were 87 (55.1%), 47 (29.7%) and 73 (46.2%), respectively. The interclass coefficient between POCT and laboratory values of sodium and potassium values was 0.74 and 0.71 respectively; P<0.001. Children with hyperlactatemia (81, 51.3%) had higher odds of shock (OR 4.58, 95% CI: 1.6-12.9), mechanical ventilation (OR 2.7, 95% CI 1.1-6.6, P=0.02) and death (OR 3.1, 95% CI 1.3-7.5 P=0.01) compared to those with normal lactate. CONCLUSION: POCT can be used as an adjunct for rapid assessment of biochemical parameters in sick children. Lactate measured by POCT was a good prognostic indicator.

Molecular Determination of mirRNA-126 rs4636297, Phosphoinositide-3-Kinase Regulatory Subunit 1-Gene Variability rs7713645, rs706713 (Tyr73Tyr), rs3730089 (Met326Ile) and Their Association with Susceptibility to T2D.

Type 2 diabetes is a metabolic disease characterized by elevated blood sugar. It has serious complications and socioeconomic impact. The MicroRNAs are short single-stranded and non-coding RNA molecules. They regulate gene expression at the post-transcriptional levels. They are important for many physiological processes including metabolism, growth, and others. The phosphoinositide 3-kinase (PI3K) is important for insulin signaling and glucose uptake. The genome wide association studies have identified the association of certain loci with diseases including T2D. In this study we have examined the association of miR126 rs4636297 and Phosphoinositide-3-kinase regulatory subunit 1 (PIK3R1) gene Variations rs7713645, rs706713 (Tyr73Tyr), and rs3730089 (Met326Ile) with T2D using the amplification refractory mutation system PCR. Results indicated that there was a significant different (p-value < 0.05) in the Mir126 rs4636297 genotypes distribution between cases and controls, and the minor allele of the rs4636297 was also associated with T2D with OR = 0.58, p-value < 0.05. In addition results showed that there were significant differences (p-value < 0.05) of rs4636297 genotype distribution of patients with normal and patient with abnormal lipid profile. Results also showed that the PIK3R1 rs7713645 and rs3730089 genotype distribution was significantly different between cases and controls with a p-values < 0.05. In addition, the minor allele of the rs7713645 and rs3730089 were associated with T2D with OR = 0.58, p-value < 0.05. We conclude that the Mir126 rs4636297 and PIK3R1 SNPs (rs7713645 and rs3730089) were associated with T2D. These results need verification in future studies with larger sample sizes and in different populations. Protein-protein interaction and enzyme assay studies are also required to uncover the effect of the SNPs on the PI3K regulatory subunit (PI3KR1) and PI3K catalytic activity.

Collaborative AI and Laboratory Medicine integration in precision cardiovascular medicine.

Artificial Intelligence (AI) is a broad term that combines computation with sophisticated mathematical models and in turn allows the development of complex algorithms which are capable to simulate human intelligence such as problem solving and learning. It is devised to promote a significant paradigm shift in the most diverse areas of medical knowledge. On the other hand, Cardiology is a vast field dealing with diseases relating to the heart, the circulatory system, and includes coronary heart disease, cerebrovascular disease, rheumatic heart disease and other conditions. AI has emerged as a promising tool in cardiovascular medicine which is aimed in augmenting the effectiveness of the cardiologist and to extend better quality to patients. It has the ability to support decision­making and improve diagnostic and prognostic performance. Attempt has also been made to explore novel genotypes and phenotypes in existing cardiovascular diseases, improve the quality of patient care, to enablecost-effectiveness with reducereadmissionand mortality rates. Our review addresses the integration of AI and laboratory medicine as an accelerator of personalization care associated with the precision and the need of value creation services in cardiovascular medicine.

Perturbing Status of Vitamin B12 in Indian Infants and Their Mothers.

BACKGROUND: Vitamin B12 deficiency in early life can adversely affect the growth of developing brain with myriad of neurodevelopmental manifestations. At this age, the deficiency is usually the result of low maternal levels. OBJECTIVES: To assess the vitamin B12 status of healthy exclusively breast-fed Indian infants aged 1 to 6 months and their mothers. METHODS: One hundred term exclusively breast-fed infants aged 1 to 6 months attending pediatric outpatient department were recruited. Hemogram, serum B12, folate, and ferritin levels were obtained from each infant-mother pair. RESULTS: The prevalence of B12 deficiency in infants was found to be 57%. Forty-six percent of mothers were deficient. There was a positive correlation ( r = .23) between the B12 levels of the infants and their mothers. CONCLUSION: There is a high prevalence of vitamin B12 deficiency in Indian infants and their mothers. There is an urgent need to supplement our population with vitamin B12, and the best time to do this would be antenatal.

Vitamin D levels among pediatric tuberculosis patients - Does it alter following antitubercular treatment? A prospective study in 19 children.

OBJECTIVES: It is still unknown whether altered vitamin D levels observed with osteoarticular tuberculosis change during treatment in a child or modify the disease course. To find a possible answer to the above query, we investigated serial serum 25 hydroxy vitamin D concentrations in children suffering from osteoarticular tuberculosis treated with multidrug antitubercular drugs. METHODS: The prospective study enrolled 19 untreated immunocompetent children with an established diagnosis of osteoarticular tuberculosis. None of the patients were offered any therapeutic vitamin D supplementation at initiation or during the treatment. The patients were followed for response to multidrug antitubercular therapy (DOTS) at 2 months interval. Mean values of vitamin D were calculated at 0, 2, and 6 months and statistically compared. The following laboratory references for defining the vitamin D status were used: <30 nmol/L = deficiency; 30-75 nmol/L = insufficiency; >75 nmol/L = sufficiency. RESULTS: All the patients responded to antitubercular therapy. Out of the enrolled children, 73.67% had low vitamin D levels at initial presentation. There was no statistically significant difference in vitamin D levels in affected children at either 0-2 (p = 0.452), 2-6 (p = 0.240), or 0-6 months (p = 0.854) following antitubercular treatment. Although the mean vitamin D levels were higher in male patients when compared to female patients at all times, there was no statistically significant difference in vitamin D levels during treatment stages in either sex. CONCLUSIONS: Vitamin D levels were low at initiation of treatment and did not significantly improve during multidrug antitubercular treatment. Further, tuberculosis healed well with antitubercular therapy despite persistence of low serum levels of vitamin D.

Vitamin D deficiency among pediatric osteoarticular tuberculosis patients.

OBJECTIVES: We prospectively investigated serum 25 hydroxy vitamin D concentrations in children suffering from osteoarticular tuberculosis. The age or sex correlation to vitamin D levels in affected subjects was also calculated. METHODS: Twenty five untreated children with osteoarticular tuberculosis were taken as cases along with equal number of age and sex matched 'healthy' controls. The following laboratory references for defining the vitamin D status were used (<30 nmol/L = deficiency; 30-75 nmol/L = insufficiency; > 75 nmol/L = sufficiency). The cases were further grouped based on gender differences and age (<5 or >5 years). RESULTS: Out of 25 cases, there were 14 (56%) with deficiency of vitamin D. In 'apparently' healthy subjects, all 25 controls (100%) had hypovitaminosis D. The osteoarticular tuberculosis patients had significant lower levels of vitamin D when compared with their healthy peers irrespective of gender or age differences. CONCLUSIONS: The osteoarticular tuberculosis cases had low serum vitamin D levels compared to healthy controls. The low vitamin D levels were persistent irrespective of gender and age in osteoarticular tuberculosis children. There was widespread vitamin D insufficiency in apparently healthy controls.