Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders

NCT02568007 | Terminated Phase 4 Results

• 1 other identifier: 798217
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Feeding Behaviors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Anthropometrics: Skin Fold Thickness

  two months

• Anthropometrics: Mid-arm Circumference

  two months

• Anthropometrics: BMI

  two months

• Anthropometrics: Height

  two months

• Anthropometrics: Weight

  two months

Study Arms (3)

No Cyproheptadine treatment

NO INTERVENTION

Patients will receive standard of care behavior and nutritional interventions. They will not receive cyproheptadine.

Continuous Cyproheptadine

EXPERIMENTAL

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

Cycled Cyproheptadine

EXPERIMENTAL

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

Interventions

Cyproheptadine DRUG

Continuous Cyproheptadine; Cycled Cyproheptadine

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Related Publications (9)

• 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.

  PMID: 14462919 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.

  PMID: 19618661 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.

  PMID: 3359243 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.

  PMID: 15211696 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.

  PMID: 16015665 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.

  PMID: 18989154 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.

  PMID: 26019782 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.

  PMID: 24941960 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.

  PMID: 11815502 BACKGROUND

MeSH Terms

Conditions

Feeding Behavior

Interventions

Cyproheptadine

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed;

Results Point of Contact

• Title: Praveen Goday
• Organization: Medical College of Wisconsin

pgoday@mcw.edu

4142663690

Study Officials

• Praveen Goday, MD

  Medical College of Wisconsin Department of Pediatric Gastroenterology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Gastroenterology

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: October 5, 2015
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 31, 2020
• Results First Posted: January 31, 2020

Record last verified: 2020-01