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Cyproheptadine as an Appetite Stimulant

Information source: St. Justine's Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Failure to Thrive

Intervention: Cyproheptadine (Drug); Sugar pill (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: St. Justine's Hospital

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.

Clinical Details

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

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

Primary outcome: Weight gain

Secondary outcome: Feeding behaviour

Eligibility

Minimum age: 2 Years. Maximum age: 4 Years. Gender(s): Both.

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

Locations and Contacts

Ste-Justine University Health Center, Montreal, Quebec H3T1C5, Canada; Recruiting
Valerie Marchand, MD, Phone: 5143454931, Ext: 3562, Email: valerie_marchand@ssss.gouv.qc.ca
Valerie Marchand, MD, Principal Investigator
Veronique Groleau, MD, Principal Investigator
Additional Information

Starting date: December 2010
Last updated: March 14, 2011

Page last updated: August 20, 2015

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