There are about 286 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.
INTRODUCTION In 2014, 50 million children under 5 suffered from acute malnutrition, of which 16 million suffered from SAM, most of them living in sub-Saharan Africa and Southeast Asia. SAM children have higher risk of mortality (relative risk between 5 and 20). It is an underlying factor in over 50% of the 10 - 11 million preventable deaths per year among children under five. At present, 65 countries have implemented WHO recommendations for SAM treatment (both in-patient for complicated cases and outpatient for uncomplicated cases) but these programs have very low coverage, reaching only around 10 - 15 % of SAM children. In 2009 the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) issued a joint statement in an effort to harmonize the application of anthropometric criteria for SAM diagnosis and monitoring in child aged 6 - 59 months; the statement presents recommended cut-offs, and summarizes the rational for the adoption, of the following two anthropometric criteria: 1. Weight-for-Height Z-Score (WHZ): "WHO and UNICEF recommend the use of a cut-off for weight-for-height of below -3 standard deviations (SD) of the WHO standards to identify infants and children as having SAM." Additionally, analysis of existing data show that children with a WHZ < -3 have a highly elevated risk of death. 2. Mid-Upper Arm Circumference (MUAC): "WHO standards for the MUAC-for-age show that in a well-nourished population there are very few children aged 6 - 59 months with a MUAC less than 115 mm. Children with a MUAC less than 115 mm have a highly elevated risk of death compared to those who are above. Thus it is recommended to [use] the cut-off point [of] 115 mm to define SAM with MUAC." GENERAL OBJECTIVE To generate new evidence on pathophysiological process, nutritional needs and risks associated with different types of anthropometric deficits in children under 5, in order to optimize the diagnosis and treatment of SAM. SPECIFIC OBJECTIVES - To compare nutritional status, metabolism, pathophysiological process and risks in different types of SAM anthropometric diagnosis, with or without concomitant stunting (growth retardation). - To analyze the extent to which current SAM treatment is promoting recovery and healthy growth in different categories of children. - To evaluate the relevance of current discharge criteria used in nutrition programs and their association with metabolic recovery, in different age groups and among those who are stunted. - To test novel rapid tests of emerging biomarkers predicting long-term outcomes and mortality risk in the field. METHODOLOGY A wide range of supplementary information related to nutritional status, body composition, metabolic and immune status, including emerging biomarkers of metabolic deprivation and vulnerability, will be collected besides anthropometry during prospective observational studies. They will be collected with minimum level of invasiveness, compatible with field work requirements in the humanitarian context. Phase 1: Cross-sectional surveys. Phase 2: Prospective cohort studies involving SAM children between 6 months and 5 years old. Children admitted as SAM at the nutrition centers will be enrolled into the cohort. The follow up duration will be at least three months. EXPECTED OUTCOMES - Confirmation of current hypotheses related to: 1. possible misdiagnosis of SAM made by MUAC or WHZ criteria, 2. varying degree of severity and need for admission to treatment of the different types of diagnosis, 3. underlying heterogeneity of the pathophysiology. - Generation of new algorithms for the assessment and classification of malnourished children, based on the combined use of emerging biomarkers and anthropometric measures, or on the modification of anthropometric criteria. - Generation of new treatment paradigms based on the predictive value of biomarkers in combination with traditional anthropometric measures. This will enable us to assess the power of current treatment regimens to promote long-term weight gain and growth and will allow us to tailor treatment to the physiological needs of the child.
It has been observed that despite administration of apparently adequate thyroid hormone replacement in hypothyroid patients, many of them experience persistent fatigue and fatigue-related symptoms. Carnitine transports long chain fatty acids into the mitochondria whereupon the high energy source (ATP) becomes synthesized. Levocarnitine administration reduced fatigue related symptoms in hypothyroid patients receiving thyroid hormone replacement. The present study deals with alleviation of fatigue in hypothyroid patients by carnitine supplementation.
Burden: Pneumonia remains the leading infectious cause of death accounting 920,000 children under five around the world. This means a loss over 2,500 child lives every day, or over 100 every hour. Since 2000, the number of child deaths caused by pneumonia has decreased by 47 per cent. The tremendous progress made is due in part to the rapid roll-out of vaccines, better nutrition and improved care-seeking and treatment for symptoms. However, pneumonia hasn't declined as quickly as other diseases such as malaria (58%), HIV/AIDS (61%) and measles (85%). Knowledge gap: The Lancet Series on Childhood Pneumonia and Diarrhea has reported that case management is one of the three most effective interventions to reduce pneumonia deaths in children. It is also noted that cost effectiveness of these interventions in national health system needs urgent assessment. It was suggested to find out means to reduce hospital stay without compromising the quality of care. Relevance: The main purpose of our study is to compare the efficacy of two doses of parenteral Amoxicillin plus single dose Gentamicin compared to four doses of parenteral Ampicillin plus single dose Gentamicin. After 72 hours of treatment injectable Amoxicillin or injection Ampicillin will be switched to or replaced by oral Amoxicillin and will be discharged with an advice to attend to Ambulatory Care Unit (ACU) to receive once daily dose of injection Gentamicin for total 5 days. It is anticipated that this modified therapy will reduce hospitalization stay of children with severe pneumonia and would therefore be relevance in countries with resource poor setting. By reducing hospitalization period, this therapy has potentials to reduce hospital acquired infection. Hypothesis (if any): Rate of treatment failure with two doses of injectable Amoxicillin plus single dose Gentamicin will be not more than that of four doses of injectable Ampicillin plus single dose Gentamicin in the management of children between 2 months to 59 months hospitalized for WHO classified severe pneumonia.
Diarrhea is the 2nd leading cause of death in under-five children. When diarrhea continued for 14 days or more it is known as Persistent Diarrhea (PD). In low and middle income countries (LMIC), 3%-23% of acute diarrheal episodes turn to PD. PD causes 32-62% of all diarrheal deaths in LMIC, and >25% in Bangladesh in contrast to 0.8% is caused by acute diarrhea. The prevalence of PD varied from 6.3 to 16.4 %. However, no larger prospective study was conducted to evaluate the efficacy of green banana in the management of PD among children older than 6 months.An open-labeled randomized controlled clinical trial is designed to assess the efficacy of green banana mixed full strength rice suji, and full strength rice suji alone compared to 3/4th strength rice suji in the management of persistent diarrhea (PD) in children aged > 6 months to 36 months in the Dhaka Hospital of icddr,b.
It is estimated that over 200 million children under 5 years of age in developing countries are not attaining their developmental potential (e.g., neurobehavioral development) primarily because of poverty and associated health, nutritional deficiencies, and unstimulating home environment. Child's Neurobehavioral development consists of several interdependent domains of sensory-motor, cognitive-language, and social-emotional function. Experiences in the first few years of life are of particular importance because vital development occurs during this period. Early under nutrition, iron-deficiency, environmental toxins, stress, and poor stimulation and social interaction can affect brain structure and function. Stunting, inadequate cognitive stimulation, iodine deficiency, and iron deficiency anemia are identified as key risk factors, where the need for cognitive intervention is urgent, that prevent millions of young children from fulfilling their developmental potential and neurobehavioral development. It is clear that underprivileged children require not only good health, nutrition, and wealth but also supportive and caring environments and cognitive stimulation for their optimum neurobehavioral development as in the case of Bangladesh. Cognitive function and self-esteem of mothers is crucial for having the optimum outcome from intervention. However, little is known regarding the importance of mother's cognitive ability influencing different domains of her children's neurobehavioral development. This is how, the investigators plan to measure the maternal cognitive function and to assess the neurobehavioral development of underprivileged children. The investigators will enroll 200 mothers and children as a sample of the present study. Bayley Scales of Infant and Toddler Development will be used along with other interview scales.
Burden: Diabetes mellitus is a major public health concern for both the developed and the developing countries. Globally 246 million people affected with diabetes, and will rise up to 300 million by 2025. In India, around 25% of the 25 million pregnancies are associated with gestational diabetes mellitus (GDM), and increasing rapidly over the time. Reported prevalence rates for GDM for Sri Lanka (13%) and Bangladesh (10%) have been described. However, in Bangladesh, estimate varies from 9.7% to 12.9% when different criteria were used. Knowledge gap: There is knowledge gap on whether a resource- and culturally-appropriate lifestyle intervention program will be more effective and cost effective relative to usual care in delaying incidence of T2D among women in South Asia. Evidence of developed countries indicate that a low-intensity lifestyle intervention, integrated with antenatal care in health system, optimizes healthy diet and attenuates physical activity decline in early pregnancy. Objective of the study: 1.To determine whether a resource- and culturally-appropriate lifestyle intervention program in Bangladesh , provided to women with prior gestational diabetes after delivery, will reduce the incidence of worsening of glycaemic status. 2. To explore whether the designated lifestyle intervention program is affordable, acceptable and scalable locally. Methods: Study design: An open-label parallel group pragmatic individual randomized controlled trial with blinded primary endpoint adjudication. The randomized controlled trial will be preceded by an intervention development and optimization phase. Intervention: Low intensity lifestyle modification program Duration: 4 years (48 months) Study settings: In Bangladesh, the investigators will conduct the intervention trial in 4 maternity care hospitals in Dhaka city. Sample size: A total of 1440 women with GDM from 24 hospitals (~60/hospital) will require for the RCT from 3 different countries. In Bangladesh, 360 participants from 4 selected maternity care hospitals (90 participants from each hospital, 45 cases and 45 controls) will be required. Inclusion Criteria: Absence of T2DM at 6±3months post-partum OGTT. Anticipated outcomes: Primary outcomes: Proportion of women with a change of glycaemic category, at or prior to final visit: Normal glucose tolerance to impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) or T2DM; and/or impaired fasting glucose/impaired glucose tolerance to type 2 Diabetes Mellitus (DM) Secondary outcomes: Mean changes in Body weight, Mean changes in waist circumference, Mean changes in systolic blood pressure, mean changes in fasting blood glucose, increase physical activity level from low to moderate and increase fruits and vegetable consumption, incremental cost effectiveness ratio and feasibility of intervention.
Burden: In developing countries, an estimated 219 million children do not reach their maximum potentiality because of poverty and associated risk factors. More than half of the Bangladeshi children <5 years are at risk for developmental delay due to poverty and sub-optimal home stimulation. Sometimes poor people become poorer due to catastrophic expenditure on health care and fall into the vicious cycle of poverty Knowledge gap: Although, there is evidence that conditional cash transfer helps develop poor people' health and nutritional status, little is known about the effect of unconditional cash transfer and health education (HE) programmes along with psychosocial stimulation on children' cognition and behaviour. Relevance: The study will bring an opportunity to evaluate the effect of transferring unconditional cash and health education programme along with psychosocial stimulation to poor families under safetynet programme of Bangladesh Govt. in rural areas. The study will also document direct and indirect cost to measure cost effectiveness that will help in decision making to implement the project if it shows benefits to children's development. Primary Hypothesis (if any): - Unconditional cash transfer (UCT) and health education (HE) programme will improve child's cognitive, motor and language development and behaviour compared to no intervention group. - Adding psychosocial stimulation to an unconditional cash transfer (UCT) and health education (HE) programme will will have an additive effect on Childs's cognitive, motor and language development and behaviour compared to the control groups Secondary Hypothesis: Additionally the intervention will - be cost effective, - reduce mothers' depressive symptoms and improve their self esteem - improve children's growth and household food security status - reduce domestic violence - Health seeking behaviour and health care expenditure Long-term goal: our ultimate goal is to find a suitable infrastructure to take to scale early child development activities for the whole country. Methods: It is a Cluster Randomized Controlled Trial with three-arms (i) UCT+HE+Psychosocial stimulation (ii) UCT+HE and iii) Comparison group.
Visceral leishmaniasis (VL) also known as kala-azar is a public health problem in Bangladesh. Since 2005 a national kala-azar elimination program is going on in the country. The program has preparatory, attack, consolidation and maintenance phases. The target of the program is to reduce the VL incidence less than 1 per 10,000 people at upazila (sub-district) level in VL endemic upazilas of the country. The program is heading successfully to its consolidation phase. During attack phase house to house search for VL suspects and also suspects with Post-kala-azar Dermal Leishmaniasis (PKDL) was the tool for early diagnosis of VL and PKDL cases. Indoor residual spraying with insecticide (Deltamethrin) was the method for sand fly control to reduce the transmission of the disease. Since in the consolidation phase the VL case load is many times less than that in the attack phase, house to house search for VL and PKDL cases and IRS for vector control is no more cost-effective for the program. Therefore there is a need for alternative methods for active search of VL and PKDL cases and method for sand fly control, appropriate for the consolidation phase. In the present study the investigators propose to investigate the efficacy of Inesfly 5AIGRNG TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB 123, indoor residual spraying (IRS) with Delthamethrin against a control group Methods: A cluster randomized controlled design to measure sand fly density reduction at intervention household as well as sand fly mortality by entomological methods. Outcome measures/variables: reduction of sand fly density at intervention household and sand fly corrected mortality on intervention surfaces compare to control households/conditions.
The purpose of this study is to assess the effectiveness of PTM202 in treating environmental enteric dysfunction.
This study will be a randomized observer -blinded controlled non-inferiority study to evaluate and compare the immunogenicity of locally produced Ingovax ACWY with Menomune®- A/C/Y/W-135 on a total of 88 healthy adult participants (18-45 years of age). 44 participants will receive locally produced Ingovax ACWY and 44 participants of comparator groups will receive Menomune® - A/C/Y/W which is produced by Sanofi Pasteur Inc. Vaccination will be done in Day 0 following the screening and pre-immunization blood sample collection and post-immunization blood will be collected at Study Day 30. Follow- up by home visit will be carried out from Study day 1-6 and clinic follow-up is scheduled upto Study day 90. The hypothesis of this study is: locally produced subcutaneous Meningococcal vaccine Ingovax ACWY is non inferior and immunogenic among adults in Bangladesh as compared to Menomune® - A/C/Y/W-135.