Efficacy of Vitamin D on the Clinical Management of Pediatric Patients With Asthma

NCT02571660 | Unknown Phase 3

• 1 other identifier: HGNAE 05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a disease that represents a public health problem worldwide, there are several barriers, especially in pediatric patients with this disease, them, prevent the adequate control of their condition, in addition every day there are new processing aids for this entity; within these novel research we founded the relationship between decreased vitamin D serum levels and his role in the regulating of the immune response, also this relationship in the pathophysiology of this disease and responses in the event of infectious diseases of the respiratory tract which can exacerbate symptoms in pediatric patients. We have been some of clinical trials with the aim of improving serum levels of vitamin D in asthmatic patients, however, these studies have different sources of bias and thus far there is no solid evidence that favors or denies the relationship between asthma and vitamin D, this paper aims to help generate this evidence to improve clinical management of these patients and their lung function and increase the free time crisis. In this trial two study groups which are divided for each of the interventions described below: Group low supplementation dose: 1 tablet of 400 IU was administered every 24 hours via oral, regardless of time or if it is before or after food, preferably in the morning to improve adherence to treatment, will be completed one year of treatment without suspension. Group high supplementation dose: 1 tablet of 1600 IU should be administered every 24 hours via oral, regardless of time or if it is before or after food, preferably in the morning to improve adherence to treatment, will be completed one year of treatment without suspension thereof.

Conditions

Asthma

Keywords

vitamin d levels; exacerbation of asthma; asthma control

Outcome Measures

Primary Outcomes (1)

• Free lapse of asthma exacerbation

  Compare between the group treated with vitamin D at doses of 4 RDA combined with standard treatment of asthma versus the group treated with vitamin D at doses of 1 RDA combined with standard treatment group: •Free lapse of asthma exacerbation in asthmatic patients 7-15 years of age

  1 year

Secondary Outcomes (5)

• Clinical control of asthma

  1 year

• Lung function

  1 year

• Vitamin D serum levels

  1 year

• Season levels of vitamin D

  1 year

• Serum vitamin D levels and clinical control of asthma

  1 year

Study Arms (2)

conventional treatment

ACTIVE COMPARATOR

GINA treatment fot asthma +vit.D low supplementation dose

Drug: GINA treatment fot asthma +vit.D low supplementation dose

conventional treatment + vitamin D3

EXPERIMENTAL

GINA treatment fot asthma +vit.D high supplementation dose

Drug: GINA treatment fot asthma +vit.D high supplementation dose

Interventions

GINA treatment fot asthma +vit.D low supplementation dose DRUG

Dose of 400 IU of vitamin D3 every 24 hours for 1 year + the standard treatment for asthma,

Also known as: SD group

conventional treatment

GINA treatment fot asthma +vit.D high supplementation dose DRUG

Dose of 1600 IU of vitamin D3 be allocated each 24 hours for 1 year + standard treatment for asthma

Also known as: TD group

conventional treatment + vitamin D3

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients 7 to 15 years regardless of sex diagnosed with asthma by clinical suspicion and accurate diagnosis by spirometry positive flow limitation with bronchodilator reversibility
• Controlled pediatric Pneumology service Patients
• Patients whose parents accept the child's participation by signing the informed consent. For children over 12 years the least sign the informed consent personally

You may not qualify if:

• Patients with hypocalcemia or hypercalcemia
• Patients with kidney diseases such as kidney stones, hypercalciuria, renal tubular acidosis
• Patients with moderate to severe malnutrition

Sponsors & Collaborators

• Hospital General Naval de Alta Especialidad - Escuela Medico Naval: lead

Study Sites (1)

Hospital General Naval de Alta Especialidad

Distrito Federal, Mexico City, Mexico

Location

Related Publications (33)

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Emmanuelle Dexeus Gabriel Fernandez, pediatrician

  Hospital General Naval de Alta Especialidad - Escuela Medico Naval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuelle Dexeus Gabriel Fernandez, pediatrician

CONTACT

015548573242; efv_35@hotmail.com

Julissa Ramirez, pediatrician

CONTACT

015545894581; julissa_abarca@hotmail.co

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Emmanuelle Dexeus Gabriel Fernandez Vera

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 8, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: July 1, 2017
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

ME (1)