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Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients

This study has been terminated.
(drug no longer available in canada)
Information provided by:
Lawson Health Research Institute Identifier:
First received: October 19, 2005
Last updated: January 4, 2011
Last verified: January 2011
This prospective, double-blinded study will determine the feasibility of determining the efficacy of a weekly intramuscular injection of nandrolone (an anabolic steroid) in malnourished ICU patients.The data from this study will also enable us to prepare a future grant proposal with a calculated sample size necessary to demonstrate an improvement in clinical outcome.

Condition Intervention Phase
Malnutrition Critical Illness Drug: Nandrolone (anabolic steroid) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Anabolic Steroids for the Nutritional Rehabilitation of Critically Ill Patients

Resource links provided by NLM:

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Nitrogen Balance

Secondary Outcome Measures:
  • Lean body mass
  • serum prealbumin
  • length of stay on ventilator, in ICU, in HOSPITAL
  • infectious complications
  • outcome (mortality)

Estimated Enrollment: 20
Study Start Date: October 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nandrolone
Patients receive weekly injections of nandrolone
Drug: Nandrolone (anabolic steroid)
Placebo Comparator: Placebo Drug: Placebo

Detailed Description:

Critically ill patients are particularly prone to excessive catabolism using skeletal muscle as the primary substrate as a result of maladaptation to critical illness. Ultimately, critical illness leads to a significant loss of lean body mass (LBM). For example, a 40% loss of LBM is associated with a 100% mortality. Anabolic steroids have been studied and have been shown to improve nutrition in select malnourished patient groups, however, the majority of these studies were not well designed or consisted of small sample sizes.

Our hypothesis is anabolic steroid administration will result in an augmentation of positive nitrogen balance and LBM. This increase in LBM will result in liberation from mechanical ventilation sooner than the placebo group and will result in discharge from the ICU sooner, and as a result, a reduction in morbidity (nosocomial infections) and possibly mortality.

All moderately to severly malnourished ICU patients who have an anticipated stay in ICU > 10 days, will be randomized to receive nandrolone (25 mg-females, 50 mg;males) once weekly for six weeks or placebo. All patients will receive a standard enteral nutritional regimen. Patients will be monitored for assessment of nitrogen balance, lean body mass, and length of time spent on ventilator, in ICU and in HOSP, and incidence of infections.Lean body mass will be measured using a bioimpedance analyzer.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. anticipated length of stay in ICU >10 days
  2. moderate to severe malnutrition
  3. patient tolerating enteral feeds

Exclusion Criteria:

  1. age < 18 yrs
  2. known allergy to nandrolone
  3. women of child bearing age with positive pregnancy test
  4. contraindications to intramuscular injections ie anticoagulation
  5. renal failure requiring renal replacement therapy
  6. patients with breast or prostate cancer -
  Contacts and Locations
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Please refer to this study by its identifier: NCT00242463

Canada, Ontario
London Health Sciences Centre-UC
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Michael D Sharpe, MD FRCPC London Health Sciences Centre-UC
  More Information

Responsible Party: Dr. M. Sharpe, Lawson Health Research Institute Identifier: NCT00242463     History of Changes
Other Study ID Numbers: R-05-390
11582 ( Other Identifier: REB )
Study First Received: October 19, 2005
Last Updated: January 4, 2011

Keywords provided by Lawson Health Research Institute:
anabolic steroids
intensive care unit

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Nutrition Disorders
Nandrolone decanoate
Nandrolone phenpropionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anabolic Agents processed this record on July 27, 2017