Cyproheptadine as an Appetite Stimulant

St. Justine's Hospital

Status and phase: Unknown; Phase 4

Conditions: Failure to Thrive

Treatments: Drug: Cyproheptadine; Drug: Sugar pill

Study type: Interventional

Funder types: Other

Identifiers

NCT01314989

Cypro-24

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 2 to 4 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Cyproheptadine

Active Comparator group

Description:

Cross-over study

Treatment:

Drug: Cyproheptadine

Sugar pill

Placebo Comparator group

Description:

Cross-over study

Treatment:

Drug: Sugar pill