Cyproheptadine as an Appetite Stimulant

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01314989

Enrollment

Registered

2011-03-15

Start date

2010-12-31

Completion date

2012-01-31

Last updated

2011-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failure to Thrive

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.

Interventions

DRUGCyproheptadine

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

DRUGSugar pill

liquid placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 4 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Weight gain	January 2011 to January 2012

Secondary

Measure	Time frame
Feeding behaviour	January 2011 to January 2012

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026