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Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Praveen Goday, Medical College of Wisconsin

Brief Summary:
The purpose of this study is to examine the effect of standard dosing of cyproheptadine for both cycled and continuous administration, as compared to no medication, on appetite stimulation and growth in the pediatric gastroenterology feeding team patient population. The secondary aim is to evaluate the effect, if any, of the suspected tachyphylaxis that is commonly associated with cyproheptadine use. The third aim will be to examine the type and duration of side effects of cyproheptadine in this population. The ultimate goal will be to create a standardized protocol for cyproheptadine therapy in children with feeding disorders and suboptimal growth.

Condition or disease Intervention/treatment Phase
Feeding Behaviors Drug: Cyproheptadine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Cyproheptadine
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
Drug: Cyproheptadine



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Anthropometrics: Skin Fold Thickness [ Time Frame: two months ]
    Change in skin fold thickness as measured by centimeters and z-score percentiles

  2. Anthropometrics: Mid-arm Circumference [ Time Frame: two months ]
    Change in mid-arm circumference as measure by centimeters and z-score percentiles

  3. Anthropometrics: BMI [ Time Frame: two months ]
    Change in BMI as measured by kilograms divided by meters squared and z-score percentiles

  4. Anthropometrics: Height [ Time Frame: two months ]
    Change in height as measured in centimeters and z-score percentiles

  5. Anthropometrics: Weight [ Time Frame: two months ]
    Change in weight as measured in kilograms and z-score percentiles

  6. 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.

  7. 24 Hour Diet Recall [ Time Frame: two months ]
    Change in calorie intake will be recorded



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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All children aged 1-10 years, presenting to initial intake appointment with the Pediatric Gastroenterology Feeding Team Clinic at the Children's Hospital of Wisconsin (CHW), with BMI Z score of < or equal to 0 (normal WHO BMI defined as Z score of -1 to 1), who have a parent willing to participate, will qualify for inclusion in the study. Children with vomiting due to presumed volume intolerance may be included in the study.

Exclusion Criteria:

  • Untreated organic disease Anatomical barrier to swallowing or known swallowing disorder Diagnosis of severe developmental delay or mental retardation Significant brain pathology or seizure disorder that may affect oropharyngeal motor skills On medication with known effects on appetite or interactions with cyproheptadine

Information from the National Library of Medicine

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


Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Praveen Goday, MD Medical College of Wisconsin Department of Pediatric Gastroenterology
Publications:

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Responsible Party: Praveen Goday, Professor of Pediatric Gastroenterology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02568007    
Other Study ID Numbers: 798217
First Posted: October 5, 2015    Key Record Dates
Results First Posted: January 31, 2020
Last Update Posted: January 31, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Feeding and Eating Disorders
Mental Disorders
Cyproheptadine
Antipruritics
Dermatologic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Anti-Allergic Agents