Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders
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|ClinicalTrials.gov Identifier: NCT02568007|
Recruitment Status : Terminated (Unable to enroll adequate participants)
First Posted : October 5, 2015
Results First Posted : January 31, 2020
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Feeding Behaviors||Drug: Cyproheptadine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders|
|Actual Study Start Date :||December 2015|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
No Intervention: No Cyproheptadine treatment
Patients will receive standard of care behavior and nutritional interventions. They will not receive cyproheptadine.
Experimental: 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.
Experimental: 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
- Feeding Behavior Questionnaire [ Time Frame: two months ]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).
- Anthropometrics: Skin Fold Thickness [ Time Frame: two months ]Change in skin fold thickness as measured by centimeters and z-score percentiles
- Anthropometrics: Mid-arm Circumference [ Time Frame: two months ]Change in mid-arm circumference as measure by centimeters and z-score percentiles
- Anthropometrics: BMI [ Time Frame: two months ]Change in BMI as measured by kilograms divided by meters squared and z-score percentiles
- Anthropometrics: Height [ Time Frame: two months ]Change in height as measured in centimeters and z-score percentiles
- Anthropometrics: Weight [ Time Frame: two months ]Change in weight as measured in kilograms and z-score percentiles
- Percentage of Participants Experiencing Side Effects From Cyproheptadine [ Time Frame: two months ]Patients will answer affirmative or negative to a descriptive list of side effects commonly experienced when taking cyproheptadine. Examples of these descriptive variables include nausea, emesis, etc. Percentage of patients experiencing each side effect will be calculated and compared across the course of study.
- 24 Hour Diet Recall [ Time Frame: two months ]Change in calorie intake will be recorded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568007
|Principal Investigator:||Praveen Goday, MD||Medical College of Wisconsin Department of Pediatric Gastroenterology|