Back to resultsCyproheptadine as an Appetite Stimulant
Primary Purpose
Failure to Thrive
Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Cyproheptadine
Sugar pill
Sponsored by
About this trial
This is an interventional treatment trial for Failure to Thrive
Eligibility Criteria
Inclusion Criteria:
- 2 to 4 years of age
- failure to thrive
Exclusion Criteria:
- Medication affecting appetite
- Medication interacting with Cyproheptadine
- Prematurity under 36 weeks of gestation
- Neurologic impairment
- underlying organic disease
Sites / Locations
- Ste-Justine University Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cyproheptadine
Sugar pill
Arm Description
Cross-over study
Cross-over study
Outcomes
Primary Outcome Measures
Weight gain
Secondary Outcome Measures
Feeding behaviour
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01314989
Brief Title
Cyproheptadine as an Appetite Stimulant
Official Title
Effect of Cyproheptadine on Weight Gain and Feeding Behavior in 2 to 4 Years Old Children With Failure to Thrive
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
St. Justine's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cyproheptadine is currently clinically used as an appetite stimulant for children with failure to thrive without underlying organic disease. Otherwise, no randomised control trial demonstrates the efficacy of Cyproheptadine on those patients. This is precisely what the investigators intend to demonstrate on this randomised placebo control cross-over trial. Our hypothesis is that Cyproheptadine is more efficient than placebo to improve weight gain and feeding behaviour on 2 to 4 years old children with failure to thrive.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failure to Thrive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cyproheptadine
Arm Type
Active Comparator
Arm Description
Cross-over study
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Cross-over study
Intervention Type
Drug
Intervention Name(s)
Cyproheptadine
Intervention Description
0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Intervention Description
liquid placebo
Primary Outcome Measure Information:
Title
Weight gain
Time Frame
January 2011 to January 2012
Secondary Outcome Measure Information:
Title
Feeding behaviour
Time Frame
January 2011 to January 2012
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
2 to 4 years of age
failure to thrive
Exclusion Criteria:
Medication affecting appetite
Medication interacting with Cyproheptadine
Prematurity under 36 weeks of gestation
Neurologic impairment
underlying organic disease
Facility Information:
Facility Name
Ste-Justine University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Marchand, MD
Phone
5143454931
Ext
3562
Email
valerie_marchand@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Valerie Marchand, MD
First Name & Middle Initial & Last Name & Degree
Veronique Groleau, MD
12. IPD Sharing Statement
Learn more about this trial
Cyproheptadine as an Appetite Stimulant
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