Cyproheptadine as an Appetite Stimulant

Brief Summary

Official Title: “Effect of Cyproheptadine on Weight Gain and Feeding Behavior in 2 to 4 Years Old Children With Failure to Thrive”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2011

Interventions Used in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Cyproheptadine
    • Cross-over study
  • Placebo Comparator: Sugar pill
    • Cross-over study

Outcome Measures for this Clinical Trial

Primary Measures

  • Weight gain
    • Time Frame: January 2011 to January 2012
      Safety Issue?: No

Secondary Measures

  • Feeding behaviour
    • Time Frame: January 2011 to January 2012
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 4 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • St. Justine’s Hospital
  • Provider of Information About this Clinical Study
    • Dr Valerie Marchand, Ste-Justine University Health Center

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01314989