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 (brief): 1. Burden: In low income neighborhoods in Dhaka many households share toilets which are often unsanitary and their discharge contaminates the community. 2. Knowledge gap: Behavior change messages have the potential to make people concerned about maintaining shared toilets quality, cleanliness and safety of the facility. There are many contributors to poor sanitation in low income neighborhoods in Dhaka but it's not clear that the situation can be improved with behavior change or even which specific messages to target. 3. Relevance: Water Sanitation for the Urban Poor (WSUP) is a nongovernmental organization working to improve shared sanitation facilities in Dhaka. They are interested in developing and evaluating a behavior change program to improve shared sanitation in Dhaka and to generate lessons that would be relevant for other low income urban settings globally. Hypothesis: A behavior change communication intervention can improve the quality and cleanliness of sanitation services available to low-income residents of Dhaka. Objectives: 1. To deliver behavior change messages (which target key behaviors influencing the quality and cleanliness of shared sanitation facilities) to randomly selected low-income communities in Dhaka. 2. To evaluate the effectiveness of a behavior change communication intervention designed to change targeted behaviors related to the quality and cleanliness of shared sanitation facilities. Methods: Local non-governmental organizations will deliver the intervention (behavior change communication package) in randomly selected communities. For this study the investigators will assess the impact of this intervention on the targeted behaviors using follow-up surveys and spot checks.
This study is conducted globally. The aim of this study is to describe the proportion of patients with hypoglycaemic episodes and estimate the incidence of various types of hypoglycaemia in the retrospective and prospective periods.
This study will be an open-label phase III randomized clinical trial comparing different combinations and regimens of polio vaccines. The trial will compare one and two doses of IPV administered at 6 weeks or 14 weeks or 6 and 14 weeks of age. All participants will also receive bOPV at 6, 10 and 14 weeks of age.
Protein-energy malnutrition (PEM) including moderate acute malnutrition (MAM: weight-for-height z-score <-2 to -3, or mid upper arm circumference (MUAC) 115 to < 125 mm) is a major cause of morbidity and mortality in under-5 children of developing/low-income countries. Approximately 14.6% of all under-5 mortality worldwide is attributed to MAM. Prevalence of MAM among under-5 children in Bangladesh is ~12% (~1.7 million). Providing a diet containing adequate nutrients is the mainstay of treatment of children with MAM. Dietary protein is mostly derived from vegetable sources for the middle and low income population among whom the prevalence of MAM and other forms of PEM is high. It is now possible to process fish into fish peptides with longer shelf-life without refrigerator, known as 'fish Surimi' and consumed by different categories of people who need more well-balanced protein; this could be an attractive alternative to supply fish protein in the diet of children in low-income countries like Bangladesh. Fish Surimi peptide is broken down from white fish meat using plant-derived enzyme and the ingredient is just fish meat consisted of 20 different kinds of amino acids including nine essential amino acids. In human studies it is found to help lowering blood lipids, glucose, IgE, hypertension, and increasing serum albumin and total protein, and bone density. The present study is designed to assess acceptability and efficacy of 'fish Surimi' in 2-5 years old children suffering from MAM. A pilot study with two phases: to assess the i) acceptability with a small convenience sample (N=30) (phase 1); and ii) efficacy (rate of weight gain) of this fish peptide in a small convenience sample (N=70: 35 intervention 35 control) (phase 2) is proposed. Acceptability trial (first phase): The investigators will conduct this study in the study ward of Dhaka Hospital of icddr,b. For each child the study will be for two days: i.e. direct observation of food intake of two lunches and two suppers. In a randomly manner and cross over design, an individual child will be offered 5g of fish Surimi during lunch and 5g during supper in one day or the same meal without any fish peptide on the other day in a blinded manner. The investigators will observe the completeness and eagerness of eating and any possible side effect (e.g. allergy, vomiting, diarrhea etc.) over these two days. Pilot efficacy trial (second phase): The investigators will conduct a pilot trial to assess the efficacy (mainly on child weight gain) of fish Surimi given at home with various foods/meals in 2-5 years old children with MAM will be conducted in Dhaka City of Bangladesh. Children will be enrolled from the Dhaka Hospital of icddr,b after improvement of any acute illness. The intervention group will receive (as take home supplementation) two-week's ration of fish Surimi (@10g/day in two doses i.e. 5g + 5g each in airtight packet), which will be served twice daily mixed with family diet. The control group will not be provided any supplements but the parents will be given dietary advice to provide nutritious food to the child in adequate amounts, and children of both groups will receive micronutrient sprinkle. The child's guardian will be supplied with fish Surimi during initial discharge from icddr,b hospital and requested to come for a fortnightly follow up at the nutrition follow-up unit (NFU) of icddr,b. During each follow-up visit the study research assistant/health worker will do the anthropometry, collect morbidity history since the last visit/follow up and dietary history will also be taken to find out how the child is doing along with the fish Surimi intake. Treatment of any illness will be provided as per standard method by on duty physician of the Dhaka Hospital of icddr,b. The ration for next two weeks will be provided and in such way each child will be followed for ~ 3 months over six NFU-follow-up visits. To reduce the possible drop-out the both-way transportation cost (~ 150 to 250 taka) during each follow-up visit will be reimbursed to the guardians. In the middle of the two scheduled follow-up days the research assistant will call the family by cell phone to monitor the child's feeding and morbidity status. Approximately 5ml blood will be collected from the ante-cubital vein of the children for biochemical test on enrolment and at the end of 3 months and will be analyzed for haemoglobin (Hb), c-reactive protein, zinc, ferritin, albumin, total protein, and IgE. During the blood drawing days each child will be given a toy (take home).
This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is assigned at the village level where treatments are: cash transfers (north and south); cash transfers + nutrition behavior communication change (north only); food transfers (north and south); food transfers + nutrition behavior communication change (south only); food-cash split (north and south); and controls (north and south). Within treatment localities, women living in very poor households are targeted to receive benefits for two years.
The recommendation for correction of dehydration of severely malnourished children with diarrhoea includes oral rehydration and if parenteral rehydration is necessary (for example, in severe dehydration) to infuse intravenous fluids very slowly due to the concern of heart failure. There is not enough evidence to convince some of the physicians dealing with severely malnourished children with dehydrating diarrhoea (for example, cholera) that rapid rehydration per se is associated with increased incidence of over hydration and heart failure. And whether this approach is applicable in the management of severely malnourished children with severe cholera, which usually require rapid correction of water and electrolyte deficits for prevention of deaths due to hypovolaemic shock and other complications, has not been studied carefully. Recently, we have demonstrated that rapid intravenous rehydration (within 4 to 6 hours) of severely malnourished children with dehydrating cholera replacing appropriate amount of fluid was found to be safe. We feel that rapid rehydration would help in improving the renal function, acidosis and thus improve appetite and reduce ORS failure subsequently. Since our study was uncontrolled, so we have planned a randomised controlled study with adequate sample of 250 participants; 125 will be rehydrated slowly (over 10 to 12 hours) following WHO guideline and 125 patients will be rehydrated with intravenous fluid over 6 hours. Children of either gender, age 6 to 60 months, severely malnourished (Wt for length <-3 Z score of WHO growth chart or with nutritional oedema) with a history of watery of <24 hours with signs severe dehydration attending the ICDDRB Dhaka hospital will be asked to participate in this study. After the parents'/Legal guardian's consent, the children will be transferred to the study ward and will be treated according to the protocol. All children will receive similar treatment except the mode of rehydration, different for the two groups. The children will be closely monitored throughout the study period. The primary outcomes incidence of over hydration and ORS failure and secondary outcomes improvement of renal function and improvement of appetite measured by the food intake will be compared between the groups.
We hypothesize that it is feasible to integrate a program of Nutritional Care and Pychosocial Stimulation into the Community Clinics in Bangladesh and thereby improve malnourished children's growth and development after a year of intervention.
The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process [IP]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process [LP]).
Hypothesis: Primary hypothesis: 1. Oral treatment with Miltefosine in children with PKDL at allometric daily dose (based on body weight and height) for 12 weeks is safe with a cure rate of ≥95%. Secondary hypothesis: 2. Development of PKDL in children and adolescent is genetically predisposed and is associated with IL-10 & IFN-gamma gene polymorphism causing high and low serum level of IL-10 and IFN-gamma respectively. 3. Nutritional & environmental factors such as low serum vitamin E, A, D, Zn & arsenic exposure are associated with PKDL.
Background: - Burden: Pneumonia is the leading cause of morbidity and mortality in under-five children, particularly in developing countries. - Knowledge gap: Although many studies have reported an association between vitamin D deficiency and pneumonia, there is lack in information on its therapeutic impact, i.e. the impact of vitamin D supplementation in the management of childhood pneumonia. - Relevance: Vitamin D plays an important role in modulating the innate immune response against infections. We, therefore, propose to conduct this study to assess the impact of vitamin D supplementation, in addition to standard antibiotic and supportive therapy, on the outcome of severe childhood pneumonia. Hypothesis: The investigators hypothesise that in the management of hospitalized severe pneumonia in under-five children, vitamin D3 supplementation, as an adjunct to the standard antibiotic and other supportive therapy, will hasten recover from severe pneumonia and may thereby shorten duration of severe pneumonia and also reduce the risk of new episode of pneumonia. Objectives: The objective of the investigators study is to assess the clinical benefit of oral supplementation of vitamin D3, in addition to standard antibiotic and other supportive therapy, to hospitalised, under-five children with severe pneumonia. Methods: This would be a randomised, double blind, controlled clinical trial (RCT). Children of either sex, aged 3-59 months, attending the Dhaka Hospital of icddr,b, with clinically diagnosed severe pneumonia will comprise the study population. Eligible children will be allotted a sequential study number, which will have been previously assigned to vitamin D or placebo in accordance with the randomisation. The study staff and mothers/ caregivers of the children will be blinded as to whether vitamin D3 or placebo has been added to their child's diet. Infants aged 3-5 months will receive breast milk and/or infant formula, and those 6 months or older will receive "Milk Suji" as a complementary food. Vitamin D3 supplementation will be given on five consecutive days, from the day of enrolment in addition to standard antibiotic and other supportive therapy. Outcome measures/variables: Primary outcome measure will be time to resolution of severe pneumonia. Secondary outcome measures will be duration of hospitalization, fever, tachypnoea, chest in drawing, hypoxia, lethargy and inability to feed during hospital stay and as well as new episode of pneumonia after discharge.