There are about 620 clinical studies being (or have been) conducted in Bangladesh. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Background: Originally thought to be purely due to LV diastolic dysfunction, studies in western countries have suggested that heart failure with preserved ejection fraction (HFpEF) is more complex. In patients with HFpEF, LV systolic function is commonly considered normal as the global ejection fraction (EF) is normal. However, the EF reflects only the global cardiac contractile function and does not take the subclinical systolic function into consideration. Therefore more attention should be paid on this subset of heart failure population in which the frequency and magnitude of concomitant subclinical systolic dysfunction has not been clearly defined. Objective: The principal objective of this study was to assess the global longitudinal systolic function of the LV in patients with HFpEF in a tertiary level hospital with the aim of finding out the frequency and magnitude of impaired subclinical systolic dysfunction by using Global Longitudinal Strain (GLS) derived from 2D speckle tracking echocardiography and to see if there is any correlation of GLS with New York Heart Association (NYHA) functional class and BNP level in these patients. Methods: This was a cross-sectional study conducted from May 2018 to April 2019. A total of 31 patients with HFpEF (Group I) and 31 healthy volunteers of similar age and sex (Group II) were enrolled in the study by consecutive sampling. Detailed history including NYHA functional class, physical examination, relevant investigations including BNP level was done in patients with HFpEF. 2D echocardiography, color Doppler, tissue Doppler and 2D speckle tracking echocardiography was done in both groups. GLS was obtained in a total of 31 patients with HFpEF (Group I), diagnosed according to the 2016 European Society of Cardiology (ESC) guidelines for the diagnosis and treatment of acute and chronic heart failure and compared with GLS of 31 healthy volunteers (Group II), to find out the frequency and magnitude of impaired subclinical systolic function in patients with HFpEF. GLS was also compared with their NYHA functional class and BNP level to find out if any significant relationship is present. Result: All patients with HFpEF had preserved LV ejection fraction (LVEF>50%) and evidence of diastolic dysfunction. HFpEF patients demonstrated significantly lower GLS compared to healthy controls (14.92 ± 3.16 versus 20.60 ± 1.84). The reduction in LV GLS was statistically significant (p <0.001). Majority of patients with HFpEF (74.2%) had reduced GLS, when reduced GLS was defined as > 2SD below the mean value for healthy volunteers, indicating the presence of subclinical systolic dysfunction in majority of these patients. Worse GLS was associated with higher BNP levels in patients with HFpEF when modeled categorically as quartiles (p = 0.044) and also when modeled continuously (Pearson correlation, r = 0.5, p = 0.004), there was negligible correlation between LV GLS and NYHA symptom class when modeled continuously (Spearman's correlation, rs = 0.052, p = 0.789). Conclusion: Strain imaging detects impaired systolic function despite preserved global EF in patients with HFpEF. Subclinical systolic dysfunction was frequent in the majority of HFpEF patients. Lower LV GLS is associated with higher BNP level. LV GLS was not associated with NYHA functional class. Further large scale studies are recommended to confirm the findings of this study.
Background (brief): 1. Burden: Bangladesh has a population of 29.5 million adolescents, which represents nearly one-fifth of the country's total population. Adequate nutrition during this critical age period is key, and is associated with improved health and development of the future adult population, as well as that of their future off-spring bringing potential inter-generational benefits. Yet, adolescents are known to face multiple nutritional challenges related to persistent undernutrition and micronutrient deficiencies as well as rapidly rising overweight and obesity due to inadequate and inappropriate nutritional practice. A large percentage of adolescents in Bangladesh consume an inadequate diet in terms of energy content, nutrient density and diversity. To alleviate micronutrient deficiency, Moringa oleifera leaves can be used in their daily diet with a traditional manner. It contains substantial amount of protein & several essential micronutrients for growth. 2. Knowledge gap: Although, adolescence has been identified as a 'second window of opportunity" for correcting nutritional inadequacies and insufficient growth from childhood, however, they face multiple nutritional challenges related to persistent undernutrition and micronutrient deficiencies, particularly in resource poor countries like Bangladesh. 3. Relevance: About 80% of kilocalories per capita per day in Bangladesh are from micronutrient-poor foods, and 70% are from rice alone (75% for rural adolescents). A study on pregnant adolescent women showed that around 60% had low or medium dietary diversity. Among the major food groups, the routine diet of a Bangladeshi adolescent particularly lacks in protein in terms of both animal source like eggs, dairy products and plant source like legumes and nuts. Daily consumption of vitamin A-rich vegetables and fruits (other than dark-green leafy vegetables) are also inadequate. Such inadequate diet is reflected by various health outcomes. The prevalence of low Body Mass Index is 31% among married-adolescents of 15-19 years old. 13% of the adolescents are short in stature. Moringa leaves have a high amount of protein, and vitamins A & C, calcium, iron, potassium and zinc. It is well-known and easily cultivable in Bangladesh with limited resource. The high nutrient content of the leaves make it suitable to bring transformative changes in diet and feeding practices within the purchasing capacity of marginalized people due to its availability and affordability. Our proposed approach will assess the impact of locally available, affordable and culturally accepted Moringa leaves consumption into adolescent's regular diet to improve their nutritional status as a whole. 4. Hypothesis (if any): 150 gm of Sajna shak /bora (Moringa) 5 days/week) will improve haemoglobin and vitamin A status of the adolescent girls after 6 months of consumption. 5. Objectives: The study objectives are as below: 1.1 Primary: To assess the effect of consumption of Sajna shak/bora (Moringa) on haemoglobin and vitamin A status among the adolescent girls after 6 months of consumption 1.2 Secondary: Assess the effect of Sajna shak/bora (Moringa) on adolescent weight gain after 6 months of consumption 6. Methods: This will be a school-based trial. Group I (intervention) will receive 150 gm of Sajna shak/bora (Moringa) added with 25 gm concenstrated dal with 100 gm of rice as mid-morning snack in selected school 5 times a week for 6 months along with nutrition education. Group II (Control) will rice, concenstrated dal and potato vaji. Both groups will recieve calorie matched meal (411 kcal). Baseline and endline survey will be conducted. Blood sample will be collected at the baseline, at end of 3 months and at the endline. Compliance will be measured through on-spot feeding. Data on feeding, morbidity and anthropometry (height and weight) will be collected bi-monthly. 7. Outcome measures/variables: Primary outcomes: Changes in 2 biochemical markers (haemoglobin and vitamin A).
The LN is a common cause of mortality and morbidity in SLE. The use of high-dose glucocorticoids (GC) with an immunosuppressive agent is usual practice for treating this condition. Higher dose of GC use might cause adverse effects along with clinical improvement. Studies had reported comparable outcome of lower dose of GC with minimum side effects. The aim of this study was to determine the outcome of lower dose prednisolone in the induction of remission of proliferative LN. This prospective, clinical trial was conducted in Rheumatology outpatient and inpatient department of BSMMU from July 2018 to September 2019. Thirty-two subjects were enrolled after having informed consent. The ACR (American College of Rheumatology) criteria was followed for diagnosis of SLE. The patients of both genders, age ≥18 years, who fulfilled the ACR criteria of LN and unable to afford MMF were enrolled. The patient evaluation tool was SELENA-DAI and Bengali version of SF-12 questionnaire. The 24-hour urinary protein, urine R/M/E, serum creatinine, CBC, serum C3, C4 levels and anti-dsDNA were done at baseline and at final visit of the study. All patients received pulse I/V methylprednisolone 500 mg/day daily for 3 doses. After then experimental group received oral prednisolone 0.5 mg/kg/day and control group received oral prednisolone 1 mg/kg/day for a period of 4 weeks. After then the prednisolone was tapered by 10 mg/day in every two weeks until 40 mg/day, then 5 mg/day in every two weeks until 10 mg/day is reached, after two weeks the dose was tapered by 2.5 mg/day to a maintenance dose of 7.5 mg/day. Both groups were treated in the background of hydroxychloroquine (HCQ), angiotensin receptor blocker (ARB) and pulse I/V cyclophosphamide (CYC) for 6 cycle. The ethical clearance was obtained from Institutional Review Board (IRB) of BSMMU and technical clearance was taken from rheumatology technical board.
Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes mellitus. The prevalence rate is approaching towards a peak throughout the world including Bangladesh. The current intervention used in peripheral neuropathy does not bring satisfactory result. Recent trial shows that L-carnitine is effective and safe in DPN. So it is expected that L-carnitine may produce better effect in compared to other medicine used previously for alleviation of DPN.
The investigators hypothesize that school-based nutrition education will increase dietary diversity among the adolescent girls. The investigators propose a matched, pair-cluster randomized controlled trial to measure the efficacy of school-based nutrition education on dietary diversity of the adolescent girls in Bangladesh. This study will have two arms (one intervention and one control arm). After screening, based on exclusion criteria, the investigators will prepare two separate lists (one for urban and one for rural) of schools in Rangpur district. From each list, clusters (schools) will be paired based on monthly tuition fees provided by the students (as a proxy indicator of socio-economic status of the students) and infrastructure of the schools. The investigators will randomly select one pair from each list and within each pair one school will be assigned to intervention arm and another one will be assigned to control arm through randomization. Targeting an effect size of 20 percentage point reduction of inadequate dietary diversity, a minimum of 148 adolescent girls will be required for each arm. Eleven to fifteen years old adolescent girls studying in grade six, seven and eight will be recruited from each school. To ensure household level participation and support, caregivers will be invited to the school for a discussion at the beginning of the intervention. Nutritional education will be delivered using audio-visual techniques (audio-visual presentation) once in a week for each class, for 3 months. Individual (IDDS) and household dietary diversity scores (HDDS) will be used for measuring dietary diversity at individual and household level, respectively. IDDS and HDDS data will be collected at recruitment, at the end of education intervention and again after 3 months of the completion of intervention. Following national guidelines, weekly iron-folic acid (IFA) supplementation will be provided to both intervention and control arm for 3 months. For identifying the barriers to and facilitators of intake of diversified food, a qualitative research will be conducted after the intervention. Adolescent girls having improved and girls showing no improvement in individual dietary diversity score will be recruited purposively for the qualitative assessment.
The goal of this study is to assess the feasibility of implementing a group-based integrated early child development intervention through the government health system in one sub-district of Bangladesh, and to assess the resulting uptake of the intervention in the target population.
Linear growth failure, a manifestation of chronic undernutrition in early childhood, is a recalcitrant problem in resource constrained settings. The underlying causes of growth failure are multifactorial, but persistent and recurrent infection and inflammation of the gastrointestinal tract and immune activation, a condition commonly referred to as environmental enteropathy, is an important contributor. A highly enriched 13C-Sucrose Breath Test, a measure of sucrase-isomaltase activity, will be evaluated as a non-invasive biomarker of environmental enteropathy, and more specifically of intestinal brush border enzyme activity in 6 resource poor countries (Bangladesh, India, Jamaica, Kenya, Peru and Zambia) in 100 volunteers aged 12-15 months (total n=600) and evaluated relative to the lactose rhamnose test and linear and ponderal growth over a 3-6 month period following biomarker assessment. Field usability will also be assessed.
In this study the investigators had evaluated the effectiveness SILODOSIN (8 mg daily orally) in Benign prostatic Hyperplasia in comparison to Tamsulosin (0.4 mg daily orally) in a randomized controlled trial design. Study population would be patients attending Urology OPD of BSMMU Hospital, Dhaka. Target sample size will be 136 evaluable patients in each group (assuming dropout rate 20%), suffering from Benign prostatic Hyperplasia .Subjects would be observed for 1 week without any drug. At the end of 1 week, they would be randomly allocated to Silodosin or Tamsulosin and treatment continued for 12 weeks. Interim follow-up visits would be at 1,4 and 12 weeks. USG confirmation of BPH would be required for recruitment. Effectiveness of the drugs would be assessed by International Prostate Symptom score, a quality of life (QoL) assessment done by a 7-point scale. Prostate weight/volume determination by USG, Change in post voidal residual urine (PVR) by USG and Changes in peak urine flow rate by uroflowmetry. Safety would be assessed by following up vital signs, treatment emergent adverse events and routine laboratory tests for drug safety.
Background: 1. Burden: Cryptosporidiosis among the top 10 causes of diarrhea in the 1st year of life in low and middle-income countries (LMICs), with an estimated total of 48,000 annual deaths and accounting for 4.2 million disability-adjusted life years lost. 2. Knowledge gap: The only approved drug for the treatment of diarrhea caused by Cryptosporidium infection is Nitazoxanide (NTZ) but NTZ has a higher failure rate in malnourished children. The lack of effective therapy for cryptosporidiosis remains an immense knowledge gap in the efforts to improve childhood health worldwide. Hypothesis: NTZ treatment failure in malnourished infants is due to a secondary immune deficiency that can be reversed by the appropriate therapeutic treatment. Lactobacillus reuteri DSM 17938 can have a potential immune modulating effect by altering gut microbiome promoting NTZ action. Objectives: Primary: • To develop new approaches to treat and prevent cryptosporidiosis Secondary: - Determination of the treatment outcome of NTZ against cryptosporidiosis in Bangladeshi children. - Determination of the change in effectiveness of NTZ treatment in conjunction with the administration of probiotics in malnourished Bangladeshi children with cryptosporidiosis Methods: This will be a prospectively conducted randomized pilot study with 2 arms in children in the Mirpur (Dhaka, Bangladesh) slum area, where cryptosporidium infected children will receive Nitazoxanide treatment with or without the probiotic, Lactobacillus reuteri DSM 17938. Outcome measures/variables: The significance of the work lies in the ability of the study to provide new approaches to treat and prevent Cryptosporidiosis. The goal of this work is to assess the efficacy of NTZ drug in a low socioeconomic Bangladeshi population and establish new supportive therapeutic measures to the already established treatment with NTZ against in cryptosporidiosis.
It is well documented that zinc supplementation to low-income population results in the reduced incidence of childhood diarrhoea and pneumonia, and improves growth of stunted children. In Bangladesh, the risk of zinc deficiency is considered to be high and children could benefit greatly by improving their zinc intakes on a daily basis. Zinc supplementation at a national scale would be a formidable task. There is a need to find an alternative. It might be sustainable to improve intake of zinc through fortified staples, e.g. rice with increased amounts of zinc; in fact such biofortified rice has been developed through conventional breeding, which is designed to contain an amount of zinc that could meet at least 40% of the daily requirement. In the first round of the previously approved and completed studies, total absorbed zinc (TAZ) did not differ when diets containing zinc biofortified rice (ZnBfR) or conventional rice (CR) were compared. Thus, the current study is planned to repeat using a new variety of (ZnBfR) that is expected to have higher zinc content than the variety previously studied. Initially, a pilot study will be conducted in 4 participants using a modified isotope administration protocol such that the oral tracers will be given on two days each at half the original dose each day so as to provide a lower proportion of the total daily zinc intake as tracer solution. Hypotheses: 1. Young children will have greater total absorbed zinc (TAZ) when they consume mixed diets containing ZnBfR than when they consume the same diets containing CR. 2. TAZ will not differ in children who receive the ZnBfR-containing diet or the same diet containing CR plus sufficient additional zinc to match the zinc content of the ZnBfR diet. Objectives: 1. To measure the amount of zinc absorbed from ZnBfR compared with the amount absorbed from CR and from CR fortified with added zinc, using the triple stable isotope tracer ratio technique in young children. 2. To assess the intestinal function of the children, using a sugar permeability test (lactulose:mannitol test). 3. (Pilot study) To verify that the modified tracer dose will provide adequate signal for assessing zinc absorption. Methods: To assess the potentials for biofortified rice in providing a good, bioavailable source of additional zinc, it is proposed here to measure zinc absorption from rice-based meals among Bangladeshi preschool children. The amount of zinc absorbed from ZnBfR compared to that absorbed from a conventional Bangladeshi rice (Diet-CR) (control) will be measured. Zinc absorbed from ZnBfR with that from zinc-fortified conventional rice (Diet-CR+Z) will also be compared. The study will be a cross-over, randomized, controlled clinical study. Initially, a pilot study will be conducted with a modified dose of zinc stable isotope among 4 children aged 36-59 months of either sex from a peri-urban community in Dhaka. Later on, 44 children aged 36-59 months of either sex will be recruited from the same community as mentioned before, and they will be individually randomized, in equal numbers, to one of the two comparison groups, A and B. During an initial one-day acclimatization period, the study children will receive the conventional rice based diet three times a day, to confirm that they will accept the study diets and adhere to the study procedures. On study days 2 and 4, in comparison group A, the study subjects will receive either the Diet-ZnBfR or Diet-CR based on the random assignments, and they will receive Diet-CR or Diet ZnBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4), Likewise, in comparison group B, the study subjects will receive either Diet-ZnBfR or Diet-CR+Z on days 2 and 4 based on the random assignments, and they will receive Diet-CR+Z or the Diet-ZnBfR, respectively, on days 3 and 5 (i.e., the diet not received on days 2 and 4). Zinc stable isotope tracer techniques will be used to measure the fractional absorption of zinc, in which tracer : tracee ratios will be measured in spot urine samples following administration of an intravenously administered tracer (68Zn) and one of two oral tracers (70Zn, 67Zn) provided with test meals over a four-day period. Outcome measures/variables: Intake of total dietary zinc (TDZ) and phytate for each subject will be calculated during the clinical study. Fractional absorption of zinc (FAZ) will be determined from the isotopic ratios obtained in urine samples using the following equation, which shows, as an example, the calculation that will be used for zinc absorption from the diet traced with 67Zn: FAZ = 67Zn tracer:tracee ratio / 68Zn tracer:tracee ratio * (68Zn dose given IV / 67Zn dose given orally) Total absorbed zinc (TAZ) for each child will be calculated as follows: TAZ (mg/d) = TDZ (mg/d) * FAZ