Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite - Full Text View

Purpose

Lack of appetite is one of the most common reasons for visits to pediatric clinics.The symptoms usually manifest after weaning when they are introduced into the diet of infant foods containing salt.Is normally used to cyproheptadine in conjunction with vitamins C and B and also vitamins complex.

Condition	Intervention	Phase
Lack or Loss Appetite Nonorganic Origin	Drug: Apevitin BC Drug: Vitamin B Complex + Vitamin C	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Multicenter Clinical Study, Phase III, Randomized, Double-blind, of Prospectively Evaluate the Effectiveness and Tolerability of Apevitin BC Comparing to Vitamin Complex in Appetite Stimulation

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins Vitamin C

Drug Information available for: Ascorbic acid Folic acid Sodium ascorbate Vitamin B Complex Magnesium ascorbate

U.S. FDA Resources

Further study details as provided by EMS:

Primary Outcome Measures:

Evaluate the effectiveness of Apevitin BC in appetite stimulation compared to vitamin complex. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Clinical evaluation of the patient's general condition. The lowest responsible will report less data about their inappetence.

Secondary Outcome Measures:

Evaluate the tolerability of Apevitin BC in stimulating the appetite compared to vitamin complex [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
The lowest responsible will repost less data about their inappetence.Final evaluation of efficacy and tolerability.


Enrollment:	51
Study Start Date:	October 2011
Study Completion Date:	October 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Apevitin BC Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily	Drug: Apevitin BC 3.5 to 5 ml 3 times a daily
Active Comparator: Vitamin B Complex + Vitamin C Children (5 to 6 years): 3.5 ml 3 times a daily Children (7 to 15 years): 5 ml 3 times a daily	Drug: Vitamin B Complex + Vitamin C 3.5 to 5 ml 3 times a daily

Detailed Description:

Study Design:

Multicenter
Phase III
Randomized
Double Blind
Prospective and Comparative
Experiment duration: 30 days
3 visits (day 0, day 15 and day 30)
Increased appetite
Adverse event

Eligibility


Ages Eligible for Study:	5 Years to 15 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients with inappetence;
Wash out 20 days after ingestion before similar drug;
The charge of the patient must understand and consent in writing;
Responsible for the minor must be able to understand the study procedures, agree to participate and give written consent.

Exclusion Criteria:

Patients with intestinal parasitoses infection;
Patients with glaucoma open or closure angle;
Patients with predisposition to urinary retention;
Patients with stenosis peptic ulcer or pylorus - duodenal obstruction;
Debilitated patients or in acute attack of asthma;
Patients who have lass of appetite caused by any serious disease;
Patients who make use of any drugs central nervous system depressants;
Patients who make use of medicines monoamineoxidase inhibitors, tricyclic antidepressants, phenothiazines, probenecid, levodopa, phenytoin, Phenobarbital, chloramphenicol, cyclosphosphamide, cyclosporine, chlorambucil,corticotropin, mercaptopurine, isoniazid , penicillin, estrogens, contraceptives, haloperidol, ipratropium, barbiturates, primidone, salicylates.
Hypersensitivity to components of the formula
Patients who is participating in another clinical study;
No able to adhere to protocol;
Any pathology or past medical condition that can interfere with this protocol.
Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283646

Locations


Brazil
Faculdade de Medicina do ABC
Santo André, SP, Brazil
Clínica A/Z
São Paulo, SP, Brazil
Clínica Dr. Felício Savioli
São Paulo, SP, Brazil

Sponsors and Collaborators

EMS

Investigators


Study Director:	Felipe Pinho, MD	EMS

More Information


Responsible Party:	EMS
ClinicalTrials.gov Identifier:	NCT01283646 History of Changes
Other Study ID Numbers:	TRPEMS0910
Study First Received:	January 25, 2011
Last Updated:	March 1, 2013
Health Authority:	Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:


Vitamins Ascorbic Acid Folic Acid Vitamin B Complex Micronutrients Growth Substances	Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Hematinics

ClinicalTrials.gov processed this record on September 28, 2016

Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite (Inappetence)