Recruiting

Cyproheptadine

Sponsor:

St. Justine's Hospital

Code:

NCT01314989

Conditions

Failure to Thrive

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Not accepted

Interventions

Cyproheptadine

Sugar pill

Study Details

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.

Conditions

Failure to Thrive

Study ID

NCT01314989

Start date

Dec, 2010

Status verified date

Mar, 2011

Completion date

Jan, 2012

Anticipated

Primary completion date

Mar, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cyproheptadine

Cross-over study

placebo comparator: Sugar pill

Cross-over study

Interventions

Cyproheptadine

0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month

Sugar pill

liquid placebo

Primary outcome measure

  • Weight gain [ Time Frame: January 2011 to January 2012 ]

Central Contacts and Locations

Locations

Ste-Justine University Health Center

Recruiting

Montreal, Quebec, Canada, H3T1C5

Contacts

Valerie Marchand, MD

5143454931valerie_marchand@ssss.gouv.qc.ca

Principal Investigator:

Valerie Marchand, MD

More Information

Sponsor

St. Justine's Hospital

Last update posted

Mar 15, 2011

Last verified

Mar, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2011-03-15.