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

• ClinicalTrials.gov Identifier: NCT01283646
• Recruitment Status: Completed
• First Posted: January 26, 2011
• Last Update Posted: February 24, 2021
• Sponsor: EMS
• Information provided by (Responsible Party): EMS

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Lack or Loss Appetite Nonorganic Origin	Drug: Apevitin BC; Drug: Vitamin B Complex + Vitamin C	Phase 3

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: October 2011
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: October 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 15 Years (Child)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: TRPEMS0910
• First Posted: January 26, 2011
• Last Update Posted: February 24, 2021
• Last Verified: March 2013

Additional relevant MeSH terms:

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