Ongoing Trials

This page contains ongoing trials listed on one of five clinical trial registries searched by REFINE. These resources are tagged and searchable according to nutritional problem, study interventions, country, study type, and research gaps. If relevant to more than one category, the document appears in both categories. New resources are added regularly according to search criteria and standards developed by REFINE.

The objective of the research is to assess the effectiveness of adding a Household WASH component to the standard outpatient treatment of severe acute malnutrition.

Study design: cluster-randomized controlled trial comparing two interventions:

This study is a randomized controlled trial with a main goal to assess the effects of a locally-prepared food for prevention of malnutrition and stunting, in comparison with standard village practices and also a widely available aid food supplement in 8-12 villages in Guinea-Bissau. The supplement intervention will be for 24-30 weeks. The primary outcome will be cognitive tests of executive function. Secondary outcomes will be changes in standard anthropometric benchmarks of growth, hemoglobin and skin carotenoids in young children living in villages in rural Guinea-Bissau.

MUAC only is a non-inferiority trial with external control carried out between January 2017 and December 2017 in the Yako district (northern region), Burkina Faso.

The objective of this study is to evaluate an integrated protocol for acute malnourished children without medical complication. The hypotheses of the integrated protocol include :

Acute malnutrition in pregnancy is a risk factor for adverse outcomes in mothers and their unborn children. Undernutrition during pregnancy can result in maternal complications such as life-threatening hemorrhage and hypertensive disorders of pregnancy and infant complications such as intrauterine growth retardation, low birth weight, pre-term delivery and poor cognitive development.

Burden: According to Bangladesh Demographic Health Survey 2014, prevalence of stunting in under-five children is 36%. Severe acute malnutrition (SAM) is prevalent in about 3% of them. In absolute numbers, about 450,000 children suffer from SAM while several million children suffer from moderate acute malnutrition (MAM).

Severe acute malnutrition in children under 5 is defined by being too thin for a given height and/or having the left arm circumference less than a given threshold (i.e. measuring how fat or thin the arm is), and/or having swollen feet (malnutrition oedema). It affects 19 million children under five at any point in time, and is likely to result in death if left untreated.

Background (brief):
a. Burden: About 43% of pre-school children worldwide and 60% children 6-24 months of age in rural Bangladesh are anaemic and half of the burden of anaemia is assumed to be attributable to iron deficiency (ID) which may impair brain development in this critical period of life

The research seeks to determine the relative effectiveness and cost effectiveness of alternative supplementary foods in the treatment of moderate acute malnutrition (MAM) in normal program settings. The results of this study will guide decisions about what commodities to use in supplementary feeding programs in particular contexts and populations, and what factors need to be addressed to ensure maximum effectiveness in the treatment of moderate malnutrition.

This study is a randomized controlled clinical trial, and 106 children will be studied for eight weeks. Inclusion criteria are having age 24 to 59 months; mild and moderate malnutrition without edema (Anthropometric index of weight for height between the -1 and -3 z-score); filling a consent form. Exclusion criteria are being twins; food allergies and intolerance; severe anemia; liver-kidney disease; malabsorption syndrome; unwillingness to cooperate. After enrollment, children will be allocated into two groups (Intervention and Control groups) based on random number table.

An appropriate balance of omega-6 and omega-3 fatty acids is important for support of neurocognitive development in healthy infants and toddlers. In young children recovering from severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status. This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced fatty acids improve the metabolic and neurocognitive effects in young children in Malawi recovering from SAM, yielding new knowledge that also has implications for development of well-nourished children.