Cyproheptadine as an Appetite Stimulant

• Sponsor: St. Justine's Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01314989
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Failure to Thrive	Drug: Cyproheptadine; Drug: Sugar pill	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Cyproheptadine on Weight Gain and Feeding Behavior in 2 to 4 Years Old Children With Failure to Thrive
• Study Start Date: Dec 1, 2010
• Anticipated Primary Completion Date: Mar 1, 2011
• Anticipated Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cyproheptadine Cross-over study	Drug: Cyproheptadine; 0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month
Placebo Comparator: Sugar pill Cross-over study	Drug: Sugar pill; liquid placebo

Outcome Measures

Primary Outcome Measures

1. Weight gain [January 2011 to January 2012]

Secondary Outcome Measures

1. Feeding behaviour [January 2011 to January 2012]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 4 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ste-Justine University Health Center	Montreal	Quebec	Canada	H3T1C5

Sponsors and Collaborators

• St. Justine's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01314989
• Other Study ID Numbers: Cypro-24
• First Posted: Mar 15, 2011
• Last Update Posted: Mar 15, 2011
• Last Verified: Mar 1, 2011

• Additional relevant MeSH terms: Failure to Thrive; Cyproheptadine

Study Results

No Results Posted as of Mar 15, 2011