Cyproheptadine as an Appetite Stimulant

Phase 4

• Conditions: Failure to Thrive
• Interventions: Drug: Cyproheptadine; Drug: Sugar pill

• Registration Number: NCT01314989
• Lead Sponsor: St. Justine's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Status Verified: 2011-03
• Primary Completion: 2011-03
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Last Update Submitted: 2011-03-14
• Study First Posted: 2011-03-15
• Last Update Posted: 2011-03-15
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cyproheptadine	Cyproheptadine	Cross-over study
Sugar pill	Sugar pill	Cross-over study

Primary Outcome Measures

Name	Time	Method
Weight gain	January 2011 to January 2012

Secondary Outcome Measures

Name	Time	Method
Feeding behaviour	January 2011 to January 2012

Trial Locations

Locations (1)

Ste-Justine University Health Center; 🇨🇦 Montreal, Quebec, Canada