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NCT ID: NCT03523156 Not yet recruiting - Trachoma Clinical Trials

Trachoma Elimination Study by Focused Antibiotic (TESFA)

Start date: May 2018
Phase: Phase 4
Study type: Interventional

The study population consists of all households residing in eligible kebeles (sub-districts) within districts in Amhara National Regional State which are identified as having a high prevalence of trachoma and infection measured from recent trachoma impact assessments. Within each study kebele, one village will be randomly selected to serve as the sentinel study site for that kebele. Once these villages are chosen, the study team will use government-provided census records, or perform a census in each village, and will randomly choose 50 children to serve as the sentinel children for the study. After the baseline visit, all kebeles will be randomized into one of the two treatment arms to either receive standard-or-care treatment, which is an annual community-wide mass drug administration (MDA), or the enhanced antibiotic treatment. Recruitment will take place at the selected children's household. Oral informed consent will be sought from village leader/chairmen before surveys are conducted in a village. Oral informed consent will then be obtained from household heads of those houses included in the study; and then from each participating individual. Oral consents will be obtained given the low literacy rates in rural Amhara. Data collection will occur at baseline, week 4, month 12, and month 24 in both arms of the study. A head of household will be asked a series of household level questions, which will be followed by a household-level census, where all consenting participants residing in the selected households will have their eyes examined for trachoma signs. This is a non-invasive procedure whereby a trained trachoma grader flips each eyelid and examines for trachoma signs. Lastly, the selected child and one randomly selected adult will have their right eye lid swabbed for evidence of trachoma infection. The total estimated respondent burden is 30 to 45 minutes.

NCT ID: NCT03506698 Recruiting - Low Birth Weight Clinical Trials

Kangaroo Mother Care Implementation Research for Accelerating Scale-up

Start date: June 15, 2017
Phase:
Study type: Observational

The implementation research project aims to develop and evaluate models for scaling up KMC in health facilities across India and Ethiopia and thereby develop effective approaches to achieve high population coverage

NCT ID: NCT03488680 Completed - Feeding Behavior Clinical Trials

Effectiveness of Behavior Change Communication in Improving Feeding Practices, Nutritional and Health Status of Infants

Start date: May 9, 2016
Phase: N/A
Study type: Interventional

Child under nutrition is a major risk factor for ill health and mortality, contributes substantially to the burden of disease in low-income and middle-income countries and is associated with close to half of all child deaths. The prevalence of both underweight and stunting is highest in Africa and South-Central Asia. Ethiopia is one of the poorest countries in Sub- Saharan Africa, and child malnutrition is a serious public health problem where the rates for stunting (40%), underweight (25%) and wasting (9%) among children under 5 years are among the highest in the world. Globally, about 40% of child mortality less than two years is associated with inappropriate feeding practices. Optimal breastfeeding and appropriate complementary feeding could prevent 13% and 6% under-five mortality, respectively. Over two third of malnutrition is associated with inappropriate feeding practices during the first year of life. The first two years of life provides a critical window of opportunity for ensuring appropriate growth and development of children from generation to generation through optimal feeding. Hence, the objective of this study to evaluate the effectiveness of behavior change communication on optimal complementary feeding through community level actors in improving feeding practice, health and nutritional status of infants. A cluster-randomized controlled trial which was conducted in West Gojjam Zone, Northwest Ethiopia from May 9, 2016 to October, 2017. Behavior change communication on complementary feeding was conducted in the intervention kebeles/villages for 8 months. A validated interviewer administered structured questionnaire was used for collecting information on the study subjects both at the baseline and after intervention. Data will be checked, coded and double entered using EPI info and exported to SPSS version 21 for statistical analysis. The output of the study findings could be useful for health and nutrition policy makers and other concerned bodies in decision making and to design effective intervention strategies to improve feeding practices thus mitigating child malnutrition and improving their health and growth. The total budget needed to conduct the study is 7,000 US dollar.

NCT ID: NCT03465488 Recruiting - Clinical trials for Soil-transmitted Helminth Infections

Validating Egg-based Diagnostics and Molecular Markers for the Spread of Anthelmintic Resistance

StarwormsWP1
Start date: August 15, 2016
Phase: N/A
Study type: Interventional

Soil-transmitted helminths (STHs) are a group of parasitic worms that infect millions of children in sub-tropical and tropical countries, resulting in malnutrition, growth stunting, intellectual retardation and cognitive deficits. To control the morbidity due to these worms, school-based deworming programs are implemented, in which anthelminthic drugs are administered to children without prior diagnosis. The continued fight against these worms is aided by the London declaration on neglected tropical diseases, which helps sustain and expand global drug donation program, resulting in an unprecedented growth of deworming programs. However, the high degree of drug pressure makes deworming programs vulnerable to the development of anthelmintic resistance because they only rely on one drug with sometimes suboptimal efficacy and there is no availability of alternative drugs. Moreover, at present, there is no surveillance system to monitor the emergence and spread of anthelmintic resistance. It remains unclear to what extent the efficacy of drugs may have dropped and whether anthelmintic resistance is already present. This project aims to strengthen the monitoring and surveillance of drug efficacy and anthelmintic resistance in STH programs. As such, it will support deworming programs in their quest to eliminate STHs as a public health problem. The specific objectives of the first work package are to validate diagnostic tools to monitor drug efficacy and the spread of anthelmintic resistance, and to validate molecular markers for benzimidazole resistance. This study will be conducted at four different sites (Ethiopia, Tanzania, Lao PDR and Brazil) and will focus on school-aged children (age 5-14). At baseline subjects will be asked to provide a recent stool sample which will be processed using 3 different microscopic techniques (KK, Mini-Flotac and FECPAKG2). All children will be treated with a single-oral dose of albendazole (ALB) 400 mg and 14-21 days after treatment, a second stool sample will be collected from all children to again determine the fecal egg counts. At each sampling, stool is stored in preservative. Stored stool will be shipped to Belgium for DNA extraction and quantitative PCR (qPCR) analysis. A subset of the samples will be analysed by pyrosequencing to evaluate the single nucleotide polymorphisms in the b-tubulin gene. Pooling of the stored samples will also be performed to compare with the values obtained from analysing individual samples.

NCT ID: NCT03450564 Recruiting - Family Size Clinical Trials

Effect of Community-Based Interventions on Increasing Family Planning Utilization in Pastoralist Community

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

The cluster randomized controlled trial will be done in Pastoralist community of Afar region, Ethiopia for a total of nine months. There will be three arms in the study. The type of randomization will be a cluster randomized controlled trial where kebele are randomized to two different interventions and control groups together. These interventions are women education to use family planning and male education/involvement to enhance family planning use in the community.

NCT ID: NCT03423472 Recruiting - Nutrition Disorders Clinical Trials

Improving Infant Nutrition in Southern Ethiopia

Start date: February 8, 2018
Phase: N/A
Study type: Interventional

This cluster randomized controlled trial will test the effect of the promotion of vitamin A-rich orange flesh sweet potato (OFSP) production and nutrition education on vitamin A and energy intake, including any added value of the Healthy Baby Toolkit.

NCT ID: NCT03419416 Recruiting - Low Birth-weight Clinical Trials

KMC Implementation Research for Accelerating Scale-up in Oromia Region, Ethiopia

KMC-Oromia
Start date: June 24, 2017
Phase: N/A
Study type: Observational [Patient Registry]

The main objective is to implement Kangaroo Mother Care (KMC) at selected facilities in Addis Ababa and Oromia Regions to achieve high effective coverage in the catchment population.

NCT ID: NCT03394963 Not yet recruiting - Healthy Clinical Trials

Developing and Validating Food-based Dietary Guidelines and a Healthy Eating Index

Start date: June 1, 2018
Phase: N/A
Study type: Observational

Among several factors contributing to the occurrence of undernutrition, micronutrient deficiencies, overnutrition, and chronic disease, unhealthy diet is one of the most important factors that need to be addressed to tackle the burden in low- and middle-income countries. To maintain healthy eating in a population, it is crucial to develop and implement country-specific food-based dietary guidelines as well as monitor the adherence of the population with the guidelines. The aim of this study is to generate evidence that will help the development and validation of food-based dietary guidelines and a healthy eating index for Ethiopia. The method to develop Ethiopian food-based dietary guidelines is adapted from the 2015 Dutch food-based dietary guidelines and the Dutch healthy diet index development and validation process, and the 1998 FAO/WHO preparation and use of food-based dietary guidelines. A multidisciplinary technical working will be established to develop FBDGs. The working group will identify key messages for the guidelines that can address priority diet-related public health problems in Ethiopia based on the evidence that will be generated by the PhD student from Wageningen University and Research. The evidence generation will begin by identifying top ten diet-related diseases that lead to high morbidity and mortality in 2016. The nutrition situation (nutritional status, dietary pattern, and nutrient gaps) analysis will be conducted to define the objectives of FBDGs. A systematic review will be conducted by formulating research questions to address the objectives of the FBDGs. The FBDGs will be translated for a specific population subgroup using linear mathematical programming and validated for cultural appropriateness, acceptability, consumer understanding and practicality of the messages. Focus group discussions and key informant interviews will be conducted to validate the FBDGs. The most recent Ethiopian national food consumption survey data collected in 2011 will be used to develop a healthy eating index (HEI). The selection of a healthy eating component of HEI will be done based on the FBDGs. Validation of a healthy eating index will be conducted by comparing the HEI score based on 24-hour recall with the HEI score based on food frequency questionnaire for population characteristics and association with micronutrient intake with or without adjusting for energy and anthropometric measurement. Developing short food frequency questionnaire (FFQ) that can be scored with the index for dietary counseling and public health practice as well as dietary gap assessment for policy recommendation will be part of the study. Validation of FFQ will be conducted by collecting primary data among women of reproductive age in 500 households in rural and urban areas of Ethiopia. The data will be analyzed using the latest version of STATA, SPSS, and NVIVO software. Correlations and other appropriate advanced statistical technique will be applied as needed to answer the objectives of the study. Ethical approval will be received from the medical ethical committee of Wageningen University and Research and scientific and ethical review office of Ethiopian Public Health Institute. This Ph.D. research is supported by the Food Systems for Healthier Diets flagship of the CGIAR- Agriculture for Nutrition and Health Programme coordinated by International Food Policy Research Institute. Food and Agriculture Organization (FAO) and Ethiopian Public Health Institute are collaborators of this project to develop the FBDGs.

NCT ID: NCT03355287 Not yet recruiting - Clinical trials for Iron Deficiency Anemia

Iron Status in Infants in Ethiopia.

Start date: January 2018
Phase: N/A
Study type: Interventional

To assess the impact of soil iron intake from teff flour on iron status in infants in Debre Zeit, Ethiopia.

NCT ID: NCT03355222 Recruiting - Zinc Deficiency Clinical Trials

Using Eggshell Calcium to Mitigate Fluorosis in Ethiopia

Start date: January 2, 2018
Phase: N/A
Study type: Interventional

Mothers and young children in rural Ethiopia lack sufficient nutrition, and a compounding factor is presence of high levels of fluoride (> 5-10 mg/day) affecting body functions. Interventions involving chickens to provide eggs and eggshell (a source of calcium) are one solution. The overall purpose is to examine how increasing dietary calcium by using eggshell powder (ESP) reduces fluoride (F) absorption in women. It is known calcium binds F to prevent its absorption but application of this to a community based study has not been tested. The aim is to provide chickens to produce eggs for young children and to provide ESP to women (mothers). For children, an egg a day should improve growth and nutritional status. For women, the ESP provides calcium to reduce fluorosis and therefore improve function without affecting iron and zinc status. For the women, blood samples will be tested in a subsample for F, calcium, zinc and iron; urine samples will be measured for F, calcium and creatinine (to correct spot urine). Hemoglobin will be measured as an indicator of overall nutritional status in women and children. Nutritional status of young children (6-18 mo) and of their mothers prior and after the intervention (by 6 months) will be assessed. between 6 and 12 month there will be monitoring for sustainability of chilckens in the community; for continued use of egg (in children) and ESP (in women); during this time the control group will receive chickens and also undergo monitoring. The study will take place in the Rift valley of Southern Ethiopia. Identification of the knowledge, attitude and practices (KAP) of mothers on egg consumption will be done at baseline and at the end ("endline"). Caregivers will be instructed to give each child 1 egg (cooked) per day in the intervention, and one "bottle cap" of eggshell powder (1000 mg calcium) per day for themselves. Families receiving chickens will be instructed on cage construction. Throughout the study, any problems arising in keeping chickens will be recorded in order to assess the feasibility and practicality of raising chickens as way to mitigate fluorosis and improve nutritional status.