A Community Based Randomized Controlled Trial to See the Effect of Vitamin D Supplementation on Development of Diabetes Among Women with Prediabetes Residing in A Rural Community of Northern India.

BACKGROUND: The primary objective of this study was to intervene with vitamin D supplementation in rural-based women with pre-diabetes (impaired fasting glucose or impaired glucose tolerance) to prevent development of type 2 diabetes (T2DM). METHODS: This was an open-label randomized placebo-controlled trial conducted in rural women with pre-diabetes and vitamin D deficiency (Clinicaltrials.gov NCT02513888). Women aged 20-60 years with pre-diabetes were selected from rural Haryana (north India) and followed up for two years. A semi-structured questionnaire was used to collect information on socio-demographic and behavioral details, like sun exposure, dietary habits, etc., The intervention group received vitamin D supplementation while control group received lactose granules as placebo. Equal doses of calcium carbonate were given to both the groups. RESULTS: A total of 132 participants were recruited in the study (58 each in the intervention and control groups). It was observed that there was no statistical significance in the incidence of diabetes in the control group as compared to the intervention group at the end of 2 years (P = 0.701). CONCLUSION: Though during the first year there was some delay in development of DM in the intervention group but at the end of two years there was no significant effect of vitamin D supplementation in delaying the incidence of diabetes in these women after two years. TRIAL REGISTRATION: (Clinicaltrials.gov NCT02513888).

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.

Impact of daily-supervised administration of a package of iron and folic acid and vitamin B12 on hemoglobin levels among adolescent girls (12-19 years): a cluster randomized control trial.

OBJECTIVE: The prevalence of anemia has remained high among Indian adolescent girls over the past decade, despite the ongoing iron and folic acid (IFA) supplementation program. This study was conducted to assess the impact of daily supplementation of a package of IFA with vitamin B12 on hemoglobin levels among adolescent girls. METHODS: A community-based cluster-randomized trial was conducted in the rural block of Faridabad District, Haryana, India in the year 2017. A total of 760 adolescent girls in the age group of 12-19 years with mild and moderate anemia were selected from government schools. Daily-supervised administration of iron and folic acid was conducted for 90 days: experimental group-IFA (iron (60 mg), folic acid (500) mcg), and cyanocobalamin (1000 mcg), control group-IFA and placebo. Hemoglobin, serum ferritin, and vitamin B12 levels were assessed at baseline and endline. RESULTS: Two-hundred adolescent girls completed 90 doses of daily supplementation. The mean hemoglobin (experimental group: 1.3 ± 1.0 g/dL, control group: 1.6 ± 1.2 g/dL, P = 0.004) and ferritin levels (experimental group: 18.6 ± 31.5 ng/mL, control group: 18.8 ± 35.0 ng/mL, P = 0.188) increased in both the control and experiment groups. Serum vitamin B12 deficiency significantly reduced to 2.5% in the experimental group and ferritin deficiency alleviated in more than 96% of the girls post intervention. CONCLUSIONS: Daily supplementation of IFA with/without vitamin B12 for 90 days eliminated iron, vitamin B12 deficiency and reduced the overall proportion of anemia by 53.5%. However, addition of vitamin B12 to IFA supplementation had no impact on improving the hemoglobin levels among adolescent girls. The present study does not recommend provision of vitamin B12 for prevention and treatment of anemia in this population group.

Effect of Structured Yoga Program on Stress and Professional Quality of Life Among Nursing Staff in a Tertiary Care Hospital of Delhi-A Small Scale Phase-II Trial.

BACKGROUND: Nursing staff suffer from various level of stress and burnout. We aimed to assess the effect of 12 weeks of structured yoga on stress and the professional quality of life among nursing staff. DESIGN AND METHOD: An open-label, phase-II randomized clinical trial was undertaken considering a sample size of convenience was done. In service nursing staff were randomized (1:1) to intervention group and wait-list control group. Primary outcome was perceived stress which was measured by Perceived Stress Scale (PSS). Secondary measures were professional quality measured by Professional Quality of Life (ProQOL) scale, blood pressure, serum cortisol, and high-sensitive C-reactive protein. Both the per-protocol and intention to treat analysis was done. RESULTS: Total 113 participants were allocated to intervention group (n = 58, mean = 35 years, SD = 7.9 years) and wait-list control group (n = 55, mean = 32.5 years, SD = 6.8 years). After 12 weeks, 19 participants of intervention group and 32 participants of wait-list control group were included in the per-protocol analysis. Follow-up mean PSS score was 15.4 (95% CI 12.6-18.2, SD 5.8) in intervention group, 20.7 (95% CI 19.7-21.7, SD 2.8) in wait-list control group (p-value < 0.0001). The other parameters didn't differ between the groups and from baseline to end line too. CONCLUSIONS AND RELEVANCE: The finding showed supervised structured yoga may be efficacious to reduce stress. Studies with larger sample size are needed to confirm the findings. TRIAL REGISTRATION: It was approved by the Institute Ethics Committee (Reference no: IECPG-543/20.12.2017, RT-57/31.01.2018) and was registered prospectively in the Clinical Trial Registry of India prospectively (No. CTRI/2018/02/012206).

Comparison of different doses of daily iron supplementation for anemia prophylaxis in pregnancy: A systematic review.

Different doses of iron are used for oral supplementation during pregnancy throughout the world. This objective of this review is to describe the effectiveness and side effect profile of different doses of oral iron supplementation for prophylaxis of anemia among pregnant women. Published literature was searched using keywords "iron," "pregnancy," and "supplementation" and related terms. Gray literature was searched in medical libraries including National Medical Library, Dr. B. B. Dikshit library, and library of ICMR. Intervention studies comparing different doses of oral iron given as prophylaxis for anemia during pregnancy, published till December 2017, were retrieved. Studies done only among anemic patients, and studies comparing oral iron with placebo were excluded. In total, 1588 studies were obtained and 11 of them met the objectives. In global studies, prophylactic dose of 30 mg and above is shown to maintain normal hemoglobin. Among the studies from India, prophylactic dose of 120 mg showed consistent results and 60 mg showed inconsistent results in increasing both hemoglobin and ferritin levels. No significant difference in side effects was reported up to 80 mg iron in global studies and the side effects were comparable with 60 to 240 mg doses in Indian studies. It was evident from the review that a state of clinical equipoise exists for the ideal dose of iron supplementation for the prevention of anemia in pregnancy in terms of efficacy and side effect profile. Robust clinical trial as well as technical consultation is required, especially in Indian setting to explore this question further.

Disability and its association with sociodemographic factors among elderly persons residing in an urban resettlement colony, New Delhi, India.

Disability prevents an individual from performing to the fullest potential. It is multidimensional. Disability may be physical, mental, social, personal, and environmental or a combination of these. The elderly experience an increased burden of disability, especially in areas where there are limited resources and rapid urbanization. Comparison of reported disability is difficult because several definitions and scales are in use. We used the World Health Organization Disability Assessment Schedule version 2.0 (WHODAS 2.0) to study the prevalence of disability, and its association with sociodemographic factors among elderly persons residing in an urban resettlement colony, New Delhi, India. The WHODAS 2.0 provides continuous summary scores, where higher scores indicate higher disability, and vice versa. Elderly persons aged 60 years and above were selected by simple random sampling in this community-based cross-sectional study. Trained interviewers administered the semi-structured interview schedule and WHODAS 2.0. The prevalence of disability was 7.4% (5.8% - 9.3%) among the 931 participants. The prevalence was higher among females than males. Female sex, elderly aged 70 years and above, and those who were illiterate had increased risk of higher disability scores. Participants who were in government or private service had 50% decreased risk of having higher disability scores. The burden of disability was high among elderly persons residing in this resettlement colony. Community-based holistic interventions are required to mitigate the disability, and to improve the functioning of elderly persons.

Do we have a magic bullet to treat moderate and severe anemia in pregnant women?

A desperate situation may evoke a fundamental question or suggestion of a radical solution. Hence, let us first examine whether the current situation of maternal anemia in India is really desperate and therefore merits a search for a "magic bullet" as a cure.

Effect of iron and folic acid tablet versus capsule formulation on treatment compliance and iron status among pregnant women: A randomized controlled trial.

BACKGROUND: Iron supplementation during pregnancy in programmatic settings has failed to produce desired results. Formulation of iron supplementation may have a role in compliance and hematological parameters. OBJECTIVE: We did this study to compare the compliance to iron supplementation, change in mean hemoglobin and serum ferritin level after iron supplementation in capsule form and tablet form during pregnancy. MATERIALS AND METHODS: In this single-blinded (investigator blinded), active comparator, randomized controlled trial we enrolled pregnant women (aged ≥18 years) from May to November 2014 during second trimester to receive iron supplementation either as capsule (ferrous fumarate) or tablet (ferrous sulphate) during entire pregnancy. The outcome was compliance (good compliance ≥ 90%) to iron supplementation assessed by pill count and change in mean hemoglobin and serum ferritin. Statistical significance was tested using Chi-square test and Student's t test. RESULTS: We enrolled and randomized 204 pregnant women for iron supplementation; capsule form (n = 100) and tablet form (n = 104). Out of which 52 (25.5%) women (23 in capsule arm and 29 in tablet arm) were lost to follow up. As compared to tablet arm, the capsule arm had higher good compliance (22% vs 16.8%), increase in mean hemoglobin (0.79 vs 0.44 gm/dL) and increase in mean serum ferritin (2.50 vs -2.14 ng/mL), but the difference was not statistically significant. CONCLUSION: Pregnant women who received either of the formulation reported a low compliance. Iron supplementation in capsule formulation resulted in more increase in blood hemoglobin level, though clinically insignificant.

Serum calcium level among pregnant women and its association with pre-eclampsia and delivery outcomes: A cross-sectional study from North India.

BACKGROUND: Calcium requirement increases during pregnancy, thereby increasing the chances of developing hypocalcaemia. Hypocalcaemia may be associated with pregnancy-related complications. Therefore, we planned this study to estimate the prevalence of hypocalcaemia among pregnant women attending secondary care hospital, and to study the association between hypocalcaemia and pregnancy outcomes. MATERIALS AND METHODS: This study was conducted in a secondary level hospital at Ballabgarh, district Faridabad, Haryana, India. Consecutive pregnant women with gestation period more than 28 weeks were enrolled. Dietary calcium intake was ascertained using 24-hour dietary recall method. Serum calcium estimation was done by Biolis 24i auto analyser. Outcome of pregnancy (preterm delivery, low birth weight (LBW) babies, and neonatal mortality) was assessed telephonically 3 months after the enrolment. RESULTS: A total of 696 pregnant women were enrolled in the study. Mean (SD) dietary calcium intake and serum calcium level was 796.4 (360.4) mg/day and 9.56 (0.94) mg/dl respectively. Prevalence (95% CI) of hypocalcaemia was 23.9% (20.8 - 27.2%). Serum total calcium level was not associated with dietary calcium intake (p-value = 0.36). Mean serum calcium level was significantly lower in mothers who had LBW babies. Pre-eclampsia, preterm delivery, and neonatal mortality were not associated with serum calcium level. CONCLUSION: Serum calcium level may not be related to dietary calcium level. Hence, the current recommendation of calcium supplementation during antenatal period appears to be inconclusive among our study population.

Effect of directly observed oral iron supplementation during pregnancy on iron status in a rural population in Haryana: A randomized controlled trial.

BACKGROUND: In India, more than half of the pregnant women suffer from anemia. Low compliance to iron supplementation is one of the important reasons. OBJECTIVES: The objective of the study is to estimate the reduction in the prevalence of anemia, improvement in iron status, and to compare the compliance to oral iron supplementation during pregnancy between directly observed iron-folic acid (IFA) supplementation group and control group. METHODS: This was a community-based open labeled parallel block-randomized controlled trial including 400 pregnant women in a rural setting of north India. In the intervention group, the first dose of IFA every week was supervised by ASHA and women were instructed to take the remaining tablets during the week as per the prescription. In control group, IFA tablets were supplemented without direct supervision. RESULTS: After 100 days of IFA supplementation, the reduction in anemia in the intervention group was 6% higher as compared to control group (P = 0.219). The increase in the mean hemoglobin level over and above control group was 0.52 g/dl in intervention group (P < 0.001). However, the mean increase in serum ferritin level in the intervention group was similar to the control group. The mean percentage compliance in the intervention group was almost 9% higher than that of control group (P = 0.001). CONCLUSION: Directly supervised oral iron (IFA) supplementation improves compliance to oral iron (IFA) supplementation and also improves hemoglobin status among pregnant women. However, the mean increase in serum ferritin and reduction in the prevalence of anemia in the intervention group were not higher than the control group.

Comparative morbidity profile of patients attending an Ayurveda clinic and a modern medicine clinic of a primary health center in rural Haryana, India.

CONTEXT: There is a paucity of data on the profile of patients accessing traditional systems of medicine. A comparison of profile of patients attending an Ayurveda clinic with that of modern medicine clinic will help in better understanding of utilization of services and preference for system of medicine by the patients seeking health care. AIM: The aim was to study the morbidity profile of patients who attended the Ayurveda clinic of a primary health center (PHC) in rural Haryana over 1 year and compared it with that of the modern medicine clinic attendees at the same facility. MATERIALS AND METHODS: The study site was PHC, Dayalpur in block Ballabgarh, district Faridabad, Haryana, India. All new patients who attended the Ayurveda clinic of PHC Dayalpur in the year 2012 were included in the study. New attendees of modern medicine clinic of the same PHC in the year 2012 were used for comparison of profile of patients. RESULTS: In year 2012, of the total new patients registered at PHC, 26% attended Ayurveda clinic. The male-to-female ratio (0.8:1) was similar in both clinics. The representation of children up to 5 years and elderly was significantly higher (12.0% vs. 6.7% and 19.5% vs. 11.0%) in modern medicine clinic as compared to Ayurveda clinic. The most common morbidities seen in Ayurveda clinic were twak vikar or skin disease (12.3%), sandhivata or osteoarthritis (10.3%), and kasa or cough (8.5%). Three most common morbidities in modern medicine clinic were acute respiratory infection (35.7%), hypertension (10.6%), and acute febrile illness (9.2%). CONCLUSIONS: The study provided evidence that Ayurveda was popular among rural population in North India. Therefore, the Government of India's initiative of setting up Ayurveda clinic in PHCs is well founded.

Directly observed iron supplementation for control of iron deficiency anemia.

Anemia is major public health problem affecting 1.6 billion people worldwide. The poor compliance of iron supplementation remains main contributor for high prevalence of anemia. The current paper reviewed the effectiveness of direct observation of oral iron supplementation on anemia. A systematic search was performed through electronic databases and local libraries. Search strategies used subject headings and key words "directly observed" and "iron supplementation." Searches were sought through April 2014. A total of 14 articles were included in the study. Findings were presented in three categories. First, all of those reported an improvement in compliance of iron supplementation. Second, reduction in the prevalence of anemia was reported by all and third, all except one reported increased blood hemoglobin level. Directly observed an iron supplementation is an effective approach for prevention and management of anemia in vulnerable groups. However, larger trials are needed before concluding that scaling up directly observed iron supplementation through community health volunteers would be beneficial.

Dietary Calcium Intake, Serum Calcium Level, and their Association with Preeclampsia in Rural North India.

BACKGROUND: Preeclampsia in pregnancy has been shown to be associated with low serum calcium level. Though the evidence is abundant, it is equivocal. OBJECTIVES: The study aimed to estimate the dietary calcium intake and serum calcium status among pregnant women, and to document the association of the dietary calcium intake and serum calcium status with incidence of preeclampsia in the 3rd trimester of pregnancy. MATERIALS AND METHODS: A community-based cross-sectional study was conducted in the Health and Demographic Surveillance System (HDSS) site, Ballabgarh, Haryana, India. All pregnant women between 28 weeks and 36 weeks of gestation were interviewed. A semi-structured interview schedule and a 24-h dietary recall questionnaire were administered to assess the dietary calcium intake. AutoAnalyser (Biolis 24i) was used for measuring serum calcium. RESULTS: We enrolled 217 pregnant women. The mean [standard deviation (SD)] dietary calcium intake was 858 (377) mg/day. The mean (SD) serum calcium level was 9.6 mg/dL (0.56). Incidence of preeclampsia was 13.4%. Preeclampsia was not associated with hypocalcemia [odds ratio (OR) = 1.2 95% confidence interval (CI); 0.27-3.98]. CONCLUSION: The majority of pregnant women had inadequate dietary calcium intake. The prevalence of hypocalcemia was low. Low serum calcium level was not associated with preeclampsia. Calcium supplementation may not reduce preeclampsia in this population.

Pre-treatment practices among patients attending an Animal Bite Management clinic at a primary health centre in Haryana, North India.

A cross-sectional study was carried out at the Animal Bite Management (ABM) clinic in a primary health centre in the Faridabad district of Haryana. Information about socio-demographic characteristics, animal bite exposure and pre-treatment practices was obtained. Clinical examination determined the severity of the bite. All 619 patients who reported to the ABM clinic during January 2011 to December 2012 were included. Out of the total, 38% had applied chilli-oil paste, and 4% antiseptics to the wound as pre-treatment; only 30.6% had washed the wound with water. There was a direct association between traditional pre-treatment practices and delay in seeking treatment for animal bites which was statistically significant (P = 0.01). Health education of the general population with culturally appropriate Information, Education and Communication material is therefore a necessary strategy to reduce delay in seeking appropriate treatment.

Social, cultural, and land use determinants of the health and well-being of Aboriginal peoples of Canada: a path analysis.

We explored the contributions of social, cultural, and land use (SCLU) factors to Aboriginal well-being and health using path analysis and data collected from 2 of 614 First Nations in Canada. Information gathered from a structured questionnaire with questions related to seven domains of well-being and contributing factors led to key findings: (i) the SCLU domain is the most important; (ii) the most important SCLU factors are the percentage of household meals of traditional diets and the impact of government regulations on land use; (iii) the most important Health domain factors are the prevalence of mental and psychological problems and the quality of health services; and (iv) the SCLU factors of access to cultural sites, the freedom to participate in spiritual activities, and the impact of government regulations on social and cultural life have a profound effect on mental health. Improving Aboriginal well-being and health may depend on incorporating SCLU factors into new, holistic policies.

Purification and physicochemical properties of polygalacturonase from Aspergillus niger MTCC 3323.

Polygalacturonases are the pectinolytic enzymes that catalyze the hydrolytic cleavage of the polygalacturonic acid chain. In the present study, polygalacturonase from Aspergillus niger (MTCC 3323) was purified. The enzyme precipitated with 60% ethanol resulted in 1.68-fold purification. The enzyme was purified to 6.52-fold by Sephacryl S-200 gel-filtration chromatography. On SDS-PAGE analysis, enzyme was found to be a heterodimer of 34 and 69 kDa subunit. Homogeneity of the enzyme was checked by NATIVE-PAGE and its molecular weight was found to be 106 kDa. The purified enzyme showed maximum activity in the presence of polygalacturonic acid at temperature of 45 °C, pH of 4.8, reaction time of 15 min. The enzyme was stable within the pH range of 4.0-5.5 for 1 h. At 4 °C it retained 50% activity after 108 h but at room temperature it lost its 50% activity after 3h. The addition of Mn(2+), K(+), Zn(2+), Ca(2+) and Al(3+) inhibited the enzyme activity; it increased in the presence of Mg(2+) and Cu(2+) ions. Enzyme activity was increased on increasing the substrate concentration from 0.1% to 0.5%. The K(m) and V(max) values of the enzyme were found to be 0.083 mg/ml and 18.21 µmol/ml/min. The enzyme was used for guava juice extraction and clarification. The recovery of juice of enzymatically treated pulp increased from 6% to 23%. Addition of purified enzyme increased the %T(650) from 2.5 to 20.4 and °Brix from 1.9 to 4.8. The pH of the enzyme treated juice decreased from 4.5 to 3.02.

Purification of pectin methylesterase from Lycopersicon esculentum and its application.

Pectin methylesterase (PME) (3.1.1.11) is the pectin degrading enzyme which catalyses the hydrolysis of pectin methylester group, resulting in de-esterification. PME is widely distributed in plants, fungi, yeast and bacteria. In the present study, PME was extracted from tomato by using 8.8% NaCl (4°C). The crude enzyme precipitated with 60% ammonium sulphate resulted in 1.02 fold purification of the enzyme. The purification was done by ion exchange chromatography using DEAE-Cellulose column. This resulted in 1.82 fold purification of the enzyme. The molecular weight of purified enzyme was determined by SDS-PAGE which was found to be 34.0 kDa. During characterization of the purified enzyme, the maximum activity was found at temperature 50°C, pH 6.5, reaction time 45 min. Citrus pectin was the best substrate for maximum enzyme activity. The enzyme did not require any metal ion to express its activity, enzyme was found to be very stable at 4°C and at 50°C the enzyme was stable upto 2 h as it retained 70% of its activity. The K(m) and V(max) values of the enzyme were found to be 0.115 mg/ml and 1.03 µmol/ml/min. PME enhanced the pectin degradation process in apple juice clarification in combination with polygalacturonase and increased %T(650) from 1.7% to 5.6%.

Alternative medicine use in dialysis patients: potential for good and bad!

Although alternative medicines are widely used within the general population, the extent of their use within the dialysis population is unknown. It is possible that dialysis patients may be more likely to turn towards alternative therapies in view of the chronicity of their disease. In addition, this particular patient population could be at an increased risk of toxicity from these therapies due to an absence of renal excretion. A detailed assessment of complementary and alternative medicine use in our dialysis patients revealed that 18% of our patients had used or were using some form of alternative medicine therapy. An additional 63% of our patients, however, were willing to use a complementary or alternative medication. Our results suggest that hemodialysis patients are extremely receptive to the use of such therapies and are therefore exposed to all their potential benefit and harm.