Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition
MalnourishmentAdequate nutrition is one of the critical biological processes to learning and cognitive development of children. And is understandable that malnourishment affect these processes. Moreover, in recent decades it has been investigated the beneficial effects of Omega-3 in cognitive development and academic performance. However, studies have been limited. Therefore is of interest to know the effects that has supplement with Omega-3 for children 8-12 years with malnutrition in a randomized, blind, placebo-controlled.
Energy Dense Formula to People Living in Old Peoples Home
Protein-Energy MalnutritionAnorexia1 moreDietary intake in frail elderly is often lower than estimated needs due to the combined effects of the anorexia of ageing, frailty and the presence of acute and chronic disease. The objectives of the present study are to assess the effects of an oleic acid rich formula fortified with micronutrients on energy intake, vitamin- and mineral status, muscle strength and mobility. The investigators have recently performed a similar study in an acute ward setting without micronutrients.
Efficacy and Bio-availability of Artemether-Lumefantrine in Severely Malnourished Children
MalariaSevere Acute MalnutritionThe general objective of the study is to answer to the question: "Is the current dose of AL less efficacious in the severely malnourished compared to the non-severely malnourished children, and is PK in cause?" We aim to assess whether the current treatment dose is adequate for children with severe acute malnutrition, and we hope results will guide further recommendations for malaria treatment in this specific population.
Bioequivalence Study of Nabumetone 750 mg Tablets of Dr. Reddy's Under Fed Conditions
HealthyThe purpose of this study is: To Assess the bioequivalence study of Nabumetone 750 mg tablets and Relafen® 750 mg tablets in healthy, adult, human subjects under fed conditions with a washout period of 16 days. To monitor adverse events and ensure the safety of subjects.
Effect of Enteral Docosahexaenoic Acid Administration in Children With Acute Lymphoblastic Leukemia...
Acute Lymphoblastic LeukemiaMalnutritionThe purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration during the first three months of treatment reduces the deterioration of nutritional status, treatment toxicity and early mortality in children with acute lymphoblastic leukemia.
Effectiveness Trial on Alleviation of Infant Malnutrition With Fortified Spread or Maize-Soy Flour...
MalnutritionThis study tests the hypothesis that moderately underweight but not severely wasted 6-17-month old infants receiving fortified spread or maize-spy flour as a food supplement for 12 weeks grow better during the supplementation than infants who do not get any food supplement.
High/Low Dose Vit A in Diarrhea/ALRI in Severe PEM
Respiratory InfectionsDiarrhea1 moreVitamin A deficiency is an important health problem globally including Bangladesh. The problem is greater among under-five children, particularly in malnourished. Vitamin A supplementation reduces morbidity from diarrhoeal diseases and also prevents future diarrhoea episodes. However, there are conflicting reports on the role of vitamin A supplementation on morbidity from acute lower respiratory infections (ALRI) including pneumonia. In non-malnourished children supplementation has been reported to be associated with increased incidence and morbidity of ALRI. The WHO committee[1] has reviewed both the risk and benefit of mega dose (200,000 IU) vitamin A supplementation during acute illness particularly diarrhoea, irrespective of the nutritional status of under-5 children and recommended vitamin A supplementation in areas where vitamin A status is low. In Bangladesh mega dose (200,000 IU) of vitamin A is routinely supplemented to under-5 children every 6 months. Absorption of vitamin A precursors from the GI tract is reduced in severely malnourished children, who are also lacking in retinol binding protein (RBP), required for transportation of retinol to target tissues. Thus it is established that a significant portion of the supplemented vitamin A is excreted in feces and urine of malnourished children. The excretion of vitamin A increases substantially during acute infections including diarrhoeal diseases. On the other hand, due to reduced RBP, concentration of free vitamin A increases in the body resulting in the possibility of adverse events including "pseudotumor cerebri". It has recently been observed that low-dose daily supplementation of vitamin A to malnourished children produces a better effect on recovery from acute illness and also in preventing infectious diseases among under-five children. However, the limitations of those studies included a small sample size, delayed assessment of retinol after supplementation among the others. Thus WHO felt that the issue needs to be addressed in a well-designed clinical trial. We hope that our proposed study will enable us to compare the efficacy of low-dose daily administration of vitamin A with that of initial mega dose followed by daily low dose of vitamin A in malnourished children presenting with acute diarrhoeal diseases with or without ALRI. If the results of this study indicate that the daily low-dose has similar efficacy to that of the currently recommended mega dose followed by daily low-dose of vitamin A, would have important programmatic implications.
A Randomized Clinical Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children...
Malnourished Children With CancerThe purpose of this research study is to determine if megestrol acetate can be used as an appetite stimulant to improve weight gain in children with cancer and poor nutrition. The study design is a randomized, double blind, placebo controlled trial. Secondarily, we would like to determine what effect any improvement in weight has on body composition by DEXA scan. This includes whether the drug results in an increase in fat, fat-free mass, or both. If our patients gain weight we would like to know if it improves their quality of life. Finally, many children with cancer lose too much weight and require feeding to occur through a tube put down their nose into their stomach (NG feeding). The tube can be painful to put down and is uncomfortable when in. Some children may also require nutrition to be given into a vein (Total Parenteral Nutrition or TPN). We are trying to see if we can prevent these procedures from happening by having the subjects gain weight. This study will tell doctors if the drug truly works (or does not work) in children who are underweight.
Oral Rehydration SolutionContaining Amylase Resistant Starch in Severely Malnourished Children....
DiarrhoeaSevere MalnutritionSevere malnutrition is associated with a high rate of mortality, even when using the latest WHO recommendations. Watery diarrhea as observed in cholera is an additional vital risk to those children. The fragility of the children together with the complexity of the pathophysiology and the simplicity of the medical environment where the treatment is delivered are serious constraints for the development of new therapies. Dehydration is a special immediate risk in those children who already displayed altered body distribution of water with potassium, magnesium, zinc and other nutrient deficiency. Dehydration is also often associated with a decrease in appetite. In addition, the intestinal function is altered both by the infectious agent and the nutritional status of the child. Recommended therapy for those children comprises oral rehydration with ReSoMaL (modified ORS for use in severely malnourished children recommended by WHO), at a relatively low rate, with permanent monitoring; in addition, breastfeeding should not be interrupted and feeding with F100 (Milk based formula diet for use in severely malnourished children recommended by WHO) is recommended. Recently, amylase-resistant starch added to a standard WHO-ORS has been shown to reduce the duration and severity of adults with cholera. The rationale for using amylase-resistant starch was that when starch enters the colon it is metabolized by the bacteria. The short-chain fatty acids thus produced stimulate sodium absorption in the colon, just like glucose stimulates water absorption in the small intestine. In addition, this treatment would be of particular interest in malnutrition because short-chain fatty acids are specific energetic substrate for the colon.In the present project, we propose to test the hypothesis that addition of amylase-resistant starch to the already recommended treatment of severely malnourished children with cholera reduces the severity and duration of diarrhea; this could be achieved through the effect of short-chain fatty acids on colonic sodium absorption. In addition, a better recovery from malnutrition could be achieved through the energy provided by short-chain fatty acids to the colon and improved appetite through improved rehydration. Thus, the aim of the study is to measure the effect of amylase-resistant starch added to an already accepted treatment (with minimal changes) at the rehydration and rehabilitation phases of the treatment. A total of 210 children aged 6 mo to 60 mo will be studied in three groups : a) glucose based ORS and amylase-resistant starch; b) glucose based ORS without amylase resistant starch ; c) rice based ORS . The major outcome variables on the first phase (diarrhoeal duration and stool output), and second phase (food intake, weight gain) will be compared between the two treatment groups. The result of the study if found effective in reducing the duration of diarrhoea, enhance recovery from diarrhoea and malnutrition in severely malnourished children, will contribute to better case management of these children.
Dose Comparison of Amino Acids on Growth in Premature Neonates
MalnutritionMalnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate that prematurely born neonates commonly develop a severe nutritional deficit during the first weeks after birth, referred to as extrauterine growth restriction. Despite an increase in growth during the second month of hospitalization, many neonates are ultimately discharged home having grown inadequately. The early nutritional deficit affects weight gain as well as growth in length and head circumference. Growth measurements such as weight, length, and head circumference, however, are macroscopic measures of nutritional status and underestimate the physiologic consequences of prolonged nutritional deprivation. Energy and micronutrient deficiencies alter growth at a cellular and tissue level before macroscopic measures are altered. In the brain, for instance, energy is required for cell division and neuronal growth, glial cell function, and myelination. Energy deprivation may consequently alter neuronal function and growth, resulting in adverse neurodevelopmental outcomes. Immunocompetence also appears to be sensitive to the untoward effects of energy and nutritional deficiency. Malnourished neonates often exhibit immune deficiencies related to inadequate protein intake that compound an already immature immune system. Such immunodeficiency results in susceptibility to infectious agents that creates substantial morbidity and mortality to the course of intensive care for premature infants. A recent study suggests that postnatal malnutrition and growth restriction are inevitable if current recommended dietary intakes are followed. Multicenter studies show that variation in dietary intake accounts for 45% of the variation in growth. Hence, efforts have focused on determining whether nutritional deficiency and the observed growth restriction of premature infants can be prevented through the use of more optimal nutritional intake. In addition, inadequate protein support may be a primary cause for growth failure. Based on animal studies showing high in utero amino acid flux observed during the latter phase of gestation, Thureen et al have suggested the use of higher doses of amino acid supplementation in order to minimize growth restriction and improve outcomes of premature infants. However there are no large human trials that demonstrate that this approach promotes better growth or that it is safe. While small doses of amino acids may be inadequate to promote normal growth, high doses may lead to elevated serum amino acid levels and increase the occurrence of toxicity. Through the implementation of a multicenter, randomized trial and tandem mass spectrometry, the investigators propose to evaluate the effects of two distinct strategies of amino acid supplementation on serum amino acid profiles and growth of premature infants during the first 28 days of life.