Feeding Behaviors Clinical Trial
Official title:
Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders
NCT number | NCT02568007 |
Other study ID # | 798217 |
Secondary ID | |
Status | Terminated |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | December 2015 |
Est. completion date | August 2016 |
Verified date | January 2020 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 10 Years |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Medical College of Wisconsin |
Couluris M, Mayer JL, Freyer DR, Sandler E, Xu P, Krischer JP. The effect of cyproheptadine hydrochloride (periactin) and megestrol acetate (megace) on weight in children with cancer/treatment-related cachexia. J Pediatr Hematol Oncol. 2008 Nov;30(11):791-7. doi: 10.1097/MPH.0b013e3181864a5e. — View Citation
Homnick DN, Homnick BD, Reeves AJ, Marks JH, Pimentel RS, Bonnema SK. Cyproheptadine is an effective appetite stimulant in cystic fibrosis. Pediatr Pulmonol. 2004 Aug;38(2):129-34. — View Citation
Homnick DN, Marks JH, Hare KL, Bonnema SK. Long-term trial of cyproheptadine as an appetite stimulant in cystic fibrosis. Pediatr Pulmonol. 2005 Sep;40(3):251-6. — View Citation
LAVENSTEIN AF, DACANEY EP, LASAGNA L, VANMETRE TE. Effect of cyproheptadine on asthmatic children. Study of appetite, weight gain, and linear growth. JAMA. 1962 Jun 16;180:912-6. — View Citation
Mahachoklertwattana P, Wanasuwankul S, Poomthavorn P, Choubtum L, Sriphrapradang A. Short-term cyproheptadine therapy in underweight children: effects on growth and serum insulin-like growth factor-I. J Pediatr Endocrinol Metab. 2009 May;22(5):425-32. — View Citation
Najib K, Moghtaderi M, Karamizadeh Z, Fallahzadeh E. Beneficial effect of cyproheptadine on body mass index in undernourished children: a randomized controlled trial. Iran J Pediatr. 2014 Dec;24(6):753-8. Epub 2014 Dec 12. — View Citation
Powers SW, Byars KC, Mitchell MJ, Patton SR, Standiford DA, Dolan LM. Parent report of mealtime behavior and parenting stress in young children with type 1 diabetes and in healthy control subjects. Diabetes Care. 2002 Feb;25(2):313-8. — View Citation
Sakata T, Ookuma K, Fukagawa K, Fujimoto K, Yoshimatsu H, Shiraishi T, Wada H. Blockade of the histamine H1-receptor in the rat ventromedial hypothalamus and feeding elicitation. Brain Res. 1988 Feb 16;441(1-2):403-7. — View Citation
Sant'Anna AM, Hammes PS, Porporino M, Martel C, Zygmuntowicz C, Ramsay M. Use of cyproheptadine in young children with feeding difficulties and poor growth in a pediatric feeding program. J Pediatr Gastroenterol Nutr. 2014 Nov;59(5):674-8. doi: 10.1097/MPG.0000000000000467. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feeding Behavior Questionnaire | 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). | two months | |
Secondary | Anthropometrics: Skin Fold Thickness | Change in skin fold thickness as measured by centimeters and z-score percentiles | two months | |
Secondary | Anthropometrics: Mid-arm Circumference | Change in mid-arm circumference as measure by centimeters and z-score percentiles | two months | |
Secondary | Anthropometrics: BMI | Change in BMI as measured by kilograms divided by meters squared and z-score percentiles | two months | |
Secondary | Anthropometrics: Height | Change in height as measured in centimeters and z-score percentiles | two months | |
Secondary | Anthropometrics: Weight | Change in weight as measured in kilograms and z-score percentiles | two months | |
Secondary | Percentage of Participants Experiencing Side Effects From Cyproheptadine | 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. | two months | |
Secondary | 24 Hour Diet Recall | Change in calorie intake will be recorded | two months |
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