drugset / Trial / NCT02568007
Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-12
- Primary completion
- 2016-08
- Completion
- 2016-08
Publications
- Background 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. doi: 10.1001/jama.1962.03050240008002. No abstract available.
- Background 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. doi: 10.1515/jpem.2009.22.5.425.
- Background 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. doi: 10.1016/0006-8993(88)91423-0.
- Background 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. doi: 10.1002/ppul.20043.
- Background 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. doi: 10.1002/ppul.20265.
- Background 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.
- Background 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.
- Background 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.
- Background 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. doi: 10.2337/diacare.25.2.313.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyproheptadine | Small molecule | 0.25 mg/kg | — |
Indications
No indication recorded.