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


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




Oxandrolone, Placebo


Primary Children's Medical Center
Salt Lake City
United States


Not yet recruiting


University of Utah

Results (where available)

View Results


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

Clinical Trials [186 Associated Clinical Trials listed on BioPortfolio]

Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer

RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life in patients with cancer. It is not yet known whether oxandrolone is more effective than megest...

Assessment of the Treatment of Severely Burned With Anabolic Agents on Clinical Outcomes, Recovery and Rehabilitation

The purpose of the program is to study and characterize the outcome of burn injury with particular attention to improving the rehabilitation of burn survivors, including children. Various ...

Oxandrolone in Healthy Adults: A Relative Bioavailability Study

To assess the pharmacokinetics and relative bioavailability of a single dose of approximately 0.1 mg/kg of a medium chain triglyceride (MCT) oil oxandrolone solution vs. tablets in a small...

The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury

The purpose of this study is to determine the effect of oxandrolone on the function and quality of life of patients with chronic spinal cord injury.

Post - Hospital Syndrome: Profile of Functional Status by Malnutrition

Malnutrition is common problem in hospitalized geriatrics at discharge. Malnutrition is a high risk for functional limitations, impaired muscle strength and reduced quality of life.

PubMed Articles [1124 Associated PubMed Articles listed on BioPortfolio]

Reduced Postburn Hypertrophic Scarring and Improved Physical Recovery With Yearlong Administration of Oxandrolone and Propranolol.

Massive burns induce a hypermetabolic response that leads to total body wasting and impaired physical and psychosocial recovery. The administration of propranolol or oxandrolone positively affects pos...

Bayesian Gaussian regression analysis of malnutrition for children under five years of age in Ethiopia, EMDHS 2014.

The term malnutrition generally refers to both under-nutrition and over-nutrition, but this study uses the term to refer solely to a deficiency of nutrition. In Ethiopia, child malnutrition is one of ...

Serious Consequences of Malnutrition and Delirium in Frail Older Patients.

Malnutrition is highly prevalent in geriatric patients and is associated with an increased risk of death. In addition, delirium is a common condition of the older hospitalized patients. As brain has a...

The impact of malnutrition on childhood infections.

Almost half of all childhood deaths worldwide occur in children with malnutrition, predominantly in sub-Saharan Africa and South Asia. This review summarizes the mechanisms by which malnutrition and s...

Does Malnutrition Have a Genetic Component?

Malnutrition is a complex disorder, defined by an imbalance, excess, or deficiency of nutrient intake. The visible signs of malnutrition are stunted growth and wasting, but malnourished children are a...

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.

More From BioPortfolio on "Pilot Study of the Safety and Efficacy of Oxandrolone in the Prevention and Treatment of Malnutrition in Infants"

Quick Search


Relevant Topic

Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...

Searches Linking to this Trial