Cyproheptadine as an Appetite Stimulant

Failure to Thrive Clinical Trial

Official title:

Effect of Cyproheptadine on Weight Gain and Feeding Behavior in 2 to 4 Years Old Children With Failure to Thrive

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01314989
• Other study ID #: Cypro-24
• Status: Recruiting
• Phase: Phase 4
• First received: March 14, 2011
• Last updated: March 14, 2011
• Start date: December 2010
• Est. completion date: January 2012

Study information

• Verified date: March 2011
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 4 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Failure to Thrive

Intervention

Drug:
• Cyproheptadine
0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month
• Sugar pill
liquid placebo

Locations

Country	Name	City	State
Canada	Ste-Justine University Health Center	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain		January 2011 to January 2012	No
Secondary	Feeding behaviour		January 2011 to January 2012	No