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Malnutrition clinical trials

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NCT ID: NCT01079260 Completed - Malnutrition Clinical Trials

An Investigation of the Efficacy of Oral Nutritional Supplements in Participants at Risk of Malnutrition

Start date: February 2010
Phase: N/A
Study type: Interventional

This study aims to investigate the efficacy of high energy, low volume oral nutritional supplements (ONS) compared to equivalent standard ONS (control) to maximize nutrient intake, compliance, gastro intestinal tolerance and function, in participants at risk of malnutrition.

NCT ID: NCT01072279 Completed - Malnutrition Clinical Trials

Preventing Malnutrition in Children Under Two Years of Age Approach

Start date: April 2010
Phase: N/A
Study type: Interventional

A study conducted by IFPRI in Haiti provided the first programmatic evidence, using a cluster randomized evaluation design, that preventing child undernutrition in children under two years of age (PM2A) through an integrated program providing food rations, BCC and preventive health and nutrition services is both feasible and highly effective. The study's principal aim was to compare a newly designed preventive approach with the traditional (recuperative) food assisted MCHN program approach, and therefore included only two comparison groups: one group of communities that was randomly assigned to the preventive approach and another group assigned to the recuperative approach. For logistical and financial reasons, the study did not include a randomized control group receiving no intervention. The Haiti study design was well-suited to achieve its main goal - i.e. to test whether the preventive approach was more effective than the recuperative approach at preventing child undernutrition - but it left a number of questions unanswered. The present study will address several of these questions, which will allow to further refine the PM2A approach, facilitate its replication in different contexts, and maximize its impact and cost-effectiveness in future programming. The study will be conducted in Guatemala and Burundi. The key research objectives are: 1. Impact and cost effectiveness: Assess the impact and cost effectiveness of PM2A on child nutritional status. 2. Optimal composition and size of food rations in PM2A: Assess the differential and absolute impact of varying the size and types of foods incorporated in the food ration of the PM2A. More specifically, assess the differential effect of different sizes of family food rations, and assess the impact of substituting the individual food ration with new micronutrient-rich products such as lipid-based nutrient supplements (LNS) or micronutrient Sprinkles. 3. Optimal timing and duration of PM2A: Assess the differential and absolute impact of varying the timing and duration of exposure to PM2A on child nutritional status.

NCT ID: NCT01057914 Completed - Malnutrition Clinical Trials

Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.

Start date: February 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effects of nutritional therapy in elderly malnourished patients. The hypothesises are that nutritional supplementation and dietary advice alone or in combination affects mortality, quality of life and health-care consumption after six month of treatment.

NCT ID: NCT01051154 Completed - Malnutrition Clinical Trials

Effect of Enteral Docosahexaenoic Acid Administration in Children With Acute Lymphoblastic Leukemia

DHA-ALL
Start date: September 2010
Phase: Phase 2
Study type: Interventional

The 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.

NCT ID: NCT01048632 Completed - Malnutrition Clinical Trials

Pilot Study of the Safety and Efficacy of Oxandrolone in the Prevention and Treatment of Malnutrition in Infants

Start date: July 2010
Phase: Phase 1
Study type: Interventional

Oxandrolone is an anabolic steroid, marketed in the United States as an adjunctive therapy to combat weight loss resulting from chronic infection, extensive surgery, severe trauma, protein catabolism associated with prolonged administration of corticosteroids, and for the relief of bone pain accompanying osteoporosis. In children, it has been used to prevent and treat growth failure associated with severe burns (≥ 40% of total body surface area), Duchenne muscular dystrophy, Turner's syndrome, constitutional delay of growth and puberty, and chronic wasting in HIV-positive pediatric patients. Other applications in children have included treatment of central idiopathic precocious puberty, hereditary angioedema, and bilateral congenital anorchia. Growth failure is a common feature of infants with complex congenital heart disease, and can adversely affect outcome. This therapy has not been previously implemented in neonates thus we will evaluate the safety and efficacy of administering oxandrolone to improve growth in neonates with complex congenital heart disease who have undergone surgical palliation or repair by collecting anthropometric measurements and pharmacokinetic data. Neonates with HLHS or variant with planned Norwood Procedure. The primary aims of this pilot study are to assess safety and efficacy of oxandrolone in this population. Our goal will be to enroll 5 patients in each phase of this pilot study. The incidence of adverse events will also be monitored and compared to untreated patients. Enrollment will continue until the target of 20 total patients has been met.

NCT ID: NCT01041456 Completed - Clinical trials for Protein Malnutrition

Laparoscopic Revision From Biliopancreatic Diversion to Gastric Bypass

BPD-to-RYGB
Start date: March 2009
Phase: N/A
Study type: Observational

The aim of this study is to describe the clinical presentation, indications, and operative treatment as well as assess the morbidity, mortality, and overall performance of revisional GBP after either failed and/or complicated Biliopancreatic Diversion "BPD" for weight loss. With such information, we hope to determine what features might assist us in advancing our knowledge about mechanisms of failure after primary bariatric surgery, mechanism of action of revisional GBP, and performance of revisional GBP through traditional outcome measurements as well as identifying predictors of good or poor outcome after revisional GBP in this specific subpopulation.

NCT ID: NCT01040533 Completed - Clinical trials for Protein Malnutrition

Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass

JIB-to-RYGB
Start date: December 2008
Phase: N/A
Study type: Observational

This study objectives are the following. - To describe the updated clinical presentation, indications, and multidisciplinary medical management of patients with a failed and/or complicated jejunoileal bypass (JIB). - To analyze the feasibility, safety, and efficacy of one-stage laparoscopic re-operative gastric bypass surgery for failed and/or complicated Jejunoileal bypass (JIB) for weight loss. - To determine what factors or strategies are associated with a successful outcome. In particular, the completion of the surgery in one stage with a laparoscopic approach.

NCT ID: NCT01015950 Completed - Clinical trials for Moderate Acute Malnutrition (MAM)

Management of Children With Moderate Acute Malnutrition in Mali

Mali-MMAM
Start date: May 2010
Phase: N/A
Study type: Interventional

The objectives of the study are to assess the impact of different dietary strategies for the management of children with MAM on: the children's continued participation in the nutritional rehabilitation program and their physical growth, recovery from MAM, and change in micronutrient status and body composition. The specific dietary regimens that will be compared are: 1) a ready-to-use, lipid-based supplementary food (Plumpy'Sup, Nutriset, Inc.), providing ~500 kcal/d for 12 weeks; 2) specially formulated CSB for malnourished children, providing ~ 500 kcal/d for 12 weeks; 3) Misola, a locally produced, micronutrient-fortified, cereal-legume blend, providing ~500 kcal/d for 12 weeks; or 4) packaged, home available foods (millet and cowpea flour, sugar, vegetable oil) and a multiple micronutrient powder ("Mix Me") for 12 weeks, as is currently recommended by the national CMAM protocol when special foods are not available.

NCT ID: NCT01000298 Completed - Kwashiorkor Clinical Trials

Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

Start date: December 2009
Phase: N/A
Study type: Interventional

The need for oral antibiotics as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not been studied in a prospective trial. This study will compare the recovery rates of children with SAM treated at home with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed antibiotics as part of their outpatient case management. The investigators hypothesize that there will be no significant difference in rates of recovery between children who receive and children who do not receive antibiotics.

NCT ID: NCT00998517 Completed - Malnutrition Clinical Trials

Effectiveness Comparison of Three Supplementary Foods in the Treatment of Moderate Acute Malnutrition

Start date: October 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the recovery rates of moderately malnourished Malawian children treated with either milk-enriched corn/soy blend, soy/peanut fortified spread or a commercially produced ready-to-use therapy food.