Trial Outcomes & Findings for Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders (NCT NCT02568007)

Results Overview

Participants' guardians will complete the Mealtime Behavior Questionnaire (MBQ). This is a validated, 31-item, parent-report questionnaire assessing the mealtime behavior structure in young children above 2 years. The questionnaire measures variables including: 1) food refusals/avoidance; 2) food manipulation; 3) mealtime aggression and 4) choking/gagging/vomiting related to meals. Each behavior is assigned a frequency scale with 1 corresponding to "never" and 5 corresponding to "always." The MBQ then consist of a total score and four subcategory scores (listed above).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

4 participants

Primary outcome timeframe

two months

Results posted on

2020-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	No Cyproheptadine Treatment Patients will receive standard of care behavior and nutritional interventions. They will not receive cyproheptadine.	Continuous Cyproheptadine Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for a total of two months. Standard dose of 0.25 mg/kg divided BID will be used. Cyproheptadine
Overall Study STARTED	2	2
Overall Study COMPLETED	2	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Cyproheptadine Treatment n=2 Participants Patients will receive standard of care behavior and nutritional interventions. They will not receive cyproheptadine.	Continuous Cyproheptadine n=2 Participants Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for a total of two months. Standard dose of 0.25 mg/kg divided BID will be used. Cyproheptadine	Cycled Cyproheptadine Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for two weeks cycled with no cyproheptadine given for two weeks for a total of two months. Patients on cycled dosing will be given cyproheptadine for two weeks, then no medication for two weeks; repeating this cycle for the two month duration of study Cyproheptadine	Total n=4 Participants Total of all reporting groups
Age, Continuous	4 years STANDARD_DEVIATION 1.4 • n=5 Participants	4 years STANDARD_DEVIATION 1.4 • n=7 Participants	—	4 years STANDARD_DEVIATION 1.2 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	—	2 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	—	2 Participants n=4 Participants
Region of Enrollment United States	2 Participants n=5 Participants	2 Participants n=7 Participants	—	4 Participants n=4 Participants

PRIMARY outcome

Timeframe: two months

Population: Too few patients to analyze

Participants' guardians will complete the Mealtime Behavior Questionnaire (MBQ). This is a validated, 31-item, parent-report questionnaire assessing the mealtime behavior structure in young children above 2 years. The questionnaire measures variables including: 1) food refusals/avoidance; 2) food manipulation; 3) mealtime aggression and 4) choking/gagging/vomiting related to meals. Each behavior is assigned a frequency scale with 1 corresponding to "never" and 5 corresponding to "always." The MBQ then consist of a total score and four subcategory scores (listed above).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: two months

Population: Too few patients to analyze

Change in skin fold thickness as measured by centimeters and z-score percentiles