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

2014-07-23 21:11:08 | BioPortfolio

Summary

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 randomized, double-blind, placebo-controlled trial 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.

Neonates with a RACHS-1 (risk adjustment in congenital heart surgery method) score of ≥4 will be eligible for enrollment. Neonates will be randomly assigned to receive oxandrolone or placebo and then followed for 28 days. Nutritional data will be collected at five time points. The primary aims of this pilot study are to assess safety and efficacy of oxandrolone in this population. Our goal will be to enroll 10 patients in each arm of this pilot study. The incidence of adverse events will also be compared between the treatment groups. Enrollment will continue until the target of 10 patients in each arm has been met.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Malnutrition

Intervention

Oxandrolone, Placebo

Location

Primary Children's Medical Center
Salt Lake City
Utah
United States
84113

Status

Not yet recruiting

Source

University of Utah

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:08-0400

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Medical and Biotech [MESH] Definitions

A synthetic hormone with anabolic and androgenic properties.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Acute form of MALNUTRITION which usually affects children, characterized by a very low weight for height (below -3z scores of the median World Health Organization standards), visible severe wasting, or occurrence of nutritional EDEMA. It can be a direct or indirect cause of fatality in children suffering from DIARRHEA and PNEUMONIA. Do not confuse with starvation, a condition in which the body is not getting enough food, usually for extended periods of time.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

General ill health, malnutrition, and weight loss, usually associated with chronic disease.

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