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.
This study is a randomized placebo-controlled trial of oral weekly vitamin D3 (cholecalciferol) supplementation during the third trimester of pregnancy among women in Dhaka, Bangladesh. The overall goal of the study is to establish whether there is evidence that improving vitamin D status among pregnant women in Bangladesh will enhance the resistance of the infant offspring to infection. The aims of the study are to assess the effect of supplementation on 1) maternal and infant vitamin D status (based on blood concentrations of a vitamin D metabolite) and, 2) markers of neonatal immune function.
This protocol will evaluate the efficacy and safety of various combinations of the three drugs; AmBisome, Paromomycin and Miltefosine at reduced total dosage against the standard treatment with a total dose of 15mg/kg of AmBisome.
Visceral leishmaniasis (VL) / Kala-azar (KA) is a public health problem in the many countries in the world including Bangladesh. Where more than 90,000 VL cases have been reported since 1994. The disease is fatal if not treated. Even with treatment the mortality rate is high (10%). VL is a vector-borne disease, caused by the parasite Leishmania donovani (LD) and is transmitted by female sandfly sp. Phlebotomus argentipes. Not all people exposed to the LD parasite develop disease. According to our observation only about 30% of the infected with LD parasite develop disease within one year of diagnosis. Malnutrition and intestinal helminth infection have been found to be associated with the risk of active VL. Down regulation of Th1 cellular immune response confers susceptibility to active VL. Both malnutrition and intestinal helminth infection down regulate the Th1 cellular immune response. Till now there is no established prophylaxis against active VL among the people exposed to the LD infection. Many studies including ours have been shown that periodic regular deworming reduced malnutrition significantly. Micronutrient such as zinc and iron as well vitamin A supplementation also improve malnutrition and may enhance Th1 cellular immune response. Thus we hypothesize that periodic deworming and. micronutrient and vitamin A supplementation together may reduce the risk of active VL among the people exposed to the LD infection. The study will be carried out in the Harirampur union, Trishal, Mymensingh. This area is highly endemic for VL. Two hundred asymptomatic VL patients aged 2-60 will be enrolled to the study. Children aged less than 2 years, pregnant women, active VL case, person with chronic disease, disable individuals and those who will refuse written consent will not be enrolled to the study. After enrollment subjects will be divided into two groups through randomization. One group will receive deworming and nutritional supplement (intervention group) and other group will receive placebo (placebo group). Two groups will be followed for 12 months through active surveillance for developing of active VL. In addition morbidity data, monthly stool sampling, monthly anthropometry, urine and blood sampling at baseline, before and after treatment of active VL will be carried out Successful completion of the study and derived results from it will provide useful information that whether periodic deworming with micronutrient and vitamin A supplementation can reduce the risk of active VL among the people exposed to the LD infection.
Zinc deficiency is a widespread public health problem in developing countries. The true prevalence of this condition remains uncertain because of lack of a specific, sensitive and reliable biomarker for assessment of human zinc status. The most widely used indicator for measuring zinc status is serum zinc level, which, however, is homeostatically regulated and influenced by stress and infection. To explore the possibility of using mRNA levels of zinc responsive genes as an indicator of zinc status, Cao and Cousins suggested metallothionein (MT) mRNA level in monocytes and peripheral blood mononuclear cells as an indicator of recent zinc uptake. However, the usefulness of MT mRNA is also limited because its level is influenced by other metals, such as copper, cadmium and cobalt and it is also affected by stress. Several authors have proposed that expression of zinc transporter genes might be useful markers of Zn status. Evidence shows reduction in dietary zinc content produces a marked increase in intestinal absorption and decrease in intestinal zinc losses. As zinc homeostasis is regulated in the intestine, study of the zinc transporters in this organ may provide indication of recent zinc uptake. Recently, a few studies have begun to investigate the applicability of using white blood cell zinc transporter expression as an indicator of zinc status and found that some of the transporters are zinc responsive. The primary objective of this study is to explore whether the expression of zinc responsive genes, such as zinc transporters in human intestinal mucosal cells, can be used as indicators of zinc status. The specific aims are to compare gene expression in: a) intestinal mucosal cells obtained by duodenal biopsy, b) sloughed intestinal mucosal cells isolated from feces, and c) peripheral blood mononuclear cells (PBMC) in fasting individuals who are receiving their usual diet + placebo or their usual diet + supplemental zinc (20 mg/d for 7 days). Gene expression values from intestinal mucosal cells (biopsy) will be compared between the placebo and zinc supplemented groups. Similar comparison will be done in the cells isolated from stool and PBMCs. This study will also provide an opportunity to compare the relative responsiveness of gene expression and serum zinc concentration following supplementation and to explore the kinetics of any changes in serum zinc concentration. Thus, blood samples will be obtained for measuring serum zinc concentration on two occasions prior to the interventions and at specified intervals during and after the intervention.
- In the formative stage of the project, we have investigated through qualitative and quantitative studies to identify a potential intervention to promote partner referral for sexually transmitted patients in Bangladesh. - We conducted a quasi-randomised trial to evaluate if single session counseling is effective in improving partner referral for patients with sexually transmitted infection.
The objective is to investigate the safety of ramipril 10 mg/day used in prevention of cardiovascular events in high-risk patients, including the criteria of the HOPE study.
The purpose of this study is to determine whether folic acid, alone or together with creatine supplementation, can lower blood arsenic concentrations and improve the ability to detoxify arsenic.
Background: Severe dehydrating cholera due to V. cholerae O1 is an important public health problem in Bangladesh and many other developing countries. V. cholerae O1 is a major bacterial pathogen causing around 5 million cases and at least 200,000 deaths in adults and children each year. It can be assumed that there are at least 300,000 severe cases and 1.2 million infections in people in Bangladesh alone. The rate of cholera varies from around 1 to 8 per 1000 population and the highest attack rate is in children 2- to 9-year years of age . Cholera is now also being documented in very young children. Currently enteric vaccine approaches are regarded as the most accessible short term and practical means to prevent and control such illnesses to prevent disease and epidemics in resource poor settings with limited public health and sanitary facilities. An effective inactivated whole cell bivalent cholera vaccine against Vibrio cholerae O1 and O139 was produced and implemented for public health purposes in Vietnam since the 1990s. This bivalent vaccine has been found to be safe and to confer significant protection against El Tor cholera in both children and adults and has over the last decade being used in the Vietnam to protect against cholera. This vaccine has further been reformulated by the IVI to meet WHO requirements and is now being produced in WHO prequalified vaccine company in India. The reformulated vaccine has been shown to be safe and immunogenic in Indian children as well as adults. A large Phase III study of the vaccine, has recently been carried out in Kolkata, India in over 120,000 participants aged from one year and above. Results of the study are encouraging and the vaccine gives over 60% protection against cholera. The vibriocidal antibody response rate was 80% in children and 53% in adults. Following this study, the vaccine, designated as ShanChol has been licensed in India in April 2009. The vaccine is now being marketed in India and is available at a cost affordable for developing country settings. Objective: The aim of the proposed study is to assess if the orally administered, killed, bivalent whole-cell cholera vaccine, ShanChol will be safe and immunogenic in different age groups in Bangladesh in children and adults. Study design: This will be a randomized, double blind, placebo-controlled study on a total of 330 subjects, 165 vaccine and 165 placebo recipients. The specific aims will be to determine: i) safety and determine adverse events if any (ii) determine immune responses. Relevance: The study of ShanChol on Bangladeshi children and adults will be able to give information regarding the safety and immunogenicity of the vaccine in Bangladeshi subjects. This information will be important for proceeding with larger studies in Bangladesh and if proven useful for introduction the cholera vaccine in the country in the future.
Efforts are continuing to improve the efficacy of oral rehydration solution in terms of reducing the severity (stool volume) and duration of diarrhoea (enhancement of recovery). Antimicrobial peptides, produced by the epithelial cells, represent an important component of the innate immunity of all epithelial surfaces of the body including intestine. Induction of expression of antimicrobial peptides on epithelial cell surface, may thus hasten recovery from infectious diarrhoea. Isoleucine is an essential amino acid that is easily available and not very expensive, and its addition to oral rehydration solution might help early clearance of diarrhoeal pathogen by inducing secretion of antimicrobial peptide by the small intestinal epithelial cells. Additionally, it is expected to hasten recovery from diarrhoea by reestablishing the commensal bacteria. The aim of this pilot study is to assess if addition of isoleucine to oral rehydration solution induces secretion of antimicrobial peptide, help establish normal bacterial populations in the intestine, and favourably impacts the severity and duration of diarrhoea in young children. If the results are found encouraging, a therapeutic trial with adequate sample size would be justified.
The efficacy and immunogenicity of enteric vaccines have generally been found to be lower in children in the developed than in the developing countries. This has been observed with vaccines against cholera rotavirus, ETEC and typhoid vaccines. There are a number of factors that may contribute to such differences in vaccine "take rates" in children, e.g. breast feeding and nutritional status of the children might influence their immunogenicity and efficacy. Thus, breast feeding of newborn and young infants may adversely influence the immune response to vaccination, which might have more pronounced effect in developing than in developed countries. Breastfeeding has also been shown to interfere with the serum immune responses to rotavirus vaccine although this effect could be overcome by administering three rather than one dose of the oral rotavirus vaccine. Our recent study of Dukoral in Bangladeshi children aged 18 months or younger has shown that the response rates and the magnitude of responses improved when breast milk was temporarily withheld . Thus, administration of vaccines may have to be adjusted when given to breast fed children. Another factor that may affect the immunogenicity is the effect of zinc. Previous studies have shown that zinc enhances the immune response to cholera vaccine in participants > 2 years of age , a recent study also observed a similar effect in infants. In this research project, we plan to study a number of different factors that might influence the immunogenicity of the two licensed oral model vaccines, specifically the inactivated killed oral cholera vaccine, Dukoral, and the live oral typhoid vaccine, Ty21a. We will also identify strategies that might improve the immunogenicity of the vaccines. The main objective of our study is to identify immunization regimens that may improve the immunogenicity of the vaccines in young children, which could be subsequently in field trials in Bangladesh and other developing countries. Specifically, we will determine if: (i) interventions identified to enhance immune responses to Dukoral, including zinc supplementation, could also enhance the immune responses to Ty21a; (ii) these two vaccines are able to induce both acute and memory B and T cell responses, (iii) treatment with antiparasitic drugs prior to immunization could modulate the immune responses to cholera and typhoid vaccines; and (iv) examine if arsenic exerts a suppressive effect on the immunogenicity of these vaccines.