Study Stopped
drug no longer available in canada
Anabolic Steroids for Nutritional Rehabilitation of Critically Ill Patients
The Efficacy of Anabolic Steroids for the Nutritional Rehabilitation of Critically Ill Patients
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 19, 2005
CompletedFirst Posted
Study publicly available on registry
October 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedJanuary 5, 2011
January 1, 2011
2 years
October 19, 2005
January 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nitrogen Balance
Secondary Outcomes (5)
Lean body mass
serum prealbumin
length of stay on ventilator, in ICU, in HOSPITAL
infectious complications
outcome (mortality)
Study Arms (2)
nandrolone
EXPERIMENTALPatients receive weekly injections of nandrolone
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- anticipated length of stay in ICU \>10 days
- moderate to severe malnutrition
- patient tolerating enteral feeds
You may not qualify if:
- age \< 18 yrs
- known allergy to nandrolone
- women of child bearing age with positive pregnancy test
- contraindications to intramuscular injections ie anticoagulation
- renal failure requiring renal replacement therapy
- patients with breast or prostate cancer -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
London Health Sciences Centre-UC
London, Ontario, N6A5A5, Canada
Related Publications (2)
Chang DW, DeSanti L, Demling RH. Anticatabolic and anabolic strategies in critical illness: a review of current treatment modalities. Shock. 1998 Sep;10(3):155-60. doi: 10.1097/00024382-199809000-00001.
PMID: 9744642BACKGROUNDJohansen KL, Mulligan K, Schambelan M. Anabolic effects of nandrolone decanoate in patients receiving dialysis: a randomized controlled trial. JAMA. 1999 Apr 14;281(14):1275-81. doi: 10.1001/jama.281.14.1275.
PMID: 10208142BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael D Sharpe, MD FRCPC
London Health Sciences Centre-UC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 19, 2005
First Posted
October 20, 2005
Study Start
October 1, 2005
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
January 5, 2011
Record last verified: 2011-01