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Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00242463
Recruitment Status : Terminated (drug no longer available in canada)
First Posted : October 20, 2005
Last Update Posted : January 5, 2011
Information provided by:
Lawson Health Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Malnutrition Critical Illness Drug: Nandrolone (anabolic steroid) Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Anabolic Steroids for the Nutritional Rehabilitation of Critically Ill Patients
Study Start Date : October 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: nandrolone
Patients receive weekly injections of nandrolone
Drug: Nandrolone (anabolic steroid)
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Nitrogen Balance

Secondary Outcome Measures :
  1. Lean body mass
  2. serum prealbumin
  3. length of stay on ventilator, in ICU, in HOSPITAL
  4. infectious complications
  5. outcome (mortality)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00242463

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

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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 )
First Posted: October 20, 2005    Key Record Dates
Last Update Posted: January 5, 2011
Last Verified: January 2011

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

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes
Nutrition Disorders
Testosterone Congeners
Nandrolone Decanoate
Nandrolone phenpropionate
Anabolic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents