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

November 24, 2015 updated by: Dr. Jorge Ivan Valencia Moncada, Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Efficacy of Vitamin D on the Clinical Management of Pediatric Patients With Asthma in the Hospital General Naval de Alta Especialidad

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are several potential mechanisms that have been described both in vitro models and in vivo models in which has been linked to asthma control with elevated levels of vitamin D in serum. These mechanisms include structural effects in the lungs, immunomodulation, modulation of smooth muscle response to level and effect on bronchial response to inhaled medicines to treat asthma.

  • Structural mechanisms Studies were conducted in rats of 50 days old, lung compliance was measured and decreased it in rats whose mothers had a diet of deprivation of vitamin D compared to those rats whose mothers received vitamin supplementation was observed. In human groups, pulmonary function tests at age 6 were carried out, and there was a significant difference between children with mothers with vitamin D deficiency during pregnancy and children whose mothers had normal levels during pregnancy. These findings suggest that there is a strong relationship between lung embryonic development serum level of vitamin D and therefore this plays a key role in the structural development of the airways
  • Anti-inflammatory Mechanisms Within these mechanisms, they are significantly inhibiting pro-inflammatory cytokines such as interleukin-6 and tumor necrosis factor alpha (TNF-A) by way of inhibition of MAP 38 produced by monocytes. Another such mechanism is the inhibition of transcription factor (necrosis factor kappa-beta). We observed a decrease in the phosphorylation and production of reactive oxygen species with the addition of 1-25 dihydroxyvitamin D levels which leads to less inflammatory damage in the respiratory epithelium.
  • Immunomodulation Effects occur in both innate immunity and adaptive, innate immunity in the effect of 1,25 hydroxyvitamin D has an effect on the reduction of inflammatory cytokines and in the decreased expression of Toll-like receptors monocytes. Also active antimicrobial peptides such as defensin 2 and 4 and the human defensin cathecidina 18, studies where low levels of vitamin D are associated and low levels of this peptide
  • Effects on helper T lymphocytes Molecular effects, vitamin D levels are associated with decreased circulating IgE as well as decreasing the TH1 response and therefore TH2, however the role of vitamin D on these cells is unclear, and some studies have shown the prevalence of TH2 response in patients with adequate levels of Vitamin D, however the decrease in the inflammatory response and the production of cytokines such as IL 12 has shown that vitamin D it modulates the response that causes pathogenesis Asthma
  • Decrease in early infections or severity The previously mentioned effects on adaptive and innate immunity may decrease the risk of early respiratory tract infections, which have been associated in the first years of life with a high incidence of wheezing. In Hawaiian children under age 5 suffering from rickets incidence of respiratory tract diseases and wheezing it was higher than that of the population without vitamin D deficiency

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Emmanuelle Dexeus Gabriel Fernández, Pediatrician
  • Phone Number: 015548573242
  • Email: efv_35@hotmail.com

Study Contact Backup

Study Locations

  • Mexico
      • Distrito Federal, Mexico
        • Hospital General Naval de Alta Especialidad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: conventional treatment
GINA treatment fot asthma +vit.D low supplementation dose
Drug: GINA treatment fot asthma +vit.D low supplementation dose
Dose of 400 IU of vitamin D3 every 24 hours for 1 year + the standard treatment for asthma,
Other Names:
  • SD group
Experimental: conventional treatment + vitamin D3
GINA treatment fot asthma +vit.D high supplementation dose
Drug: GINA treatment fot asthma +vit.D high supplementation dose
Dose of 1600 IU of vitamin D3 be allocated each 24 hours for 1 year + standard treatment for asthma
Other Names:
  • TD group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Free lapse of asthma exacerbation
Time Frame: 1 year

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical control of asthma
Time Frame: 1 year
Compare between the groups the clinical control of asthma with the questionary: asthma control test
1 year
Lung function
Time Frame: 1 year
Compare both groups improved lung function measured by spirometry using as parameter FEV 1
1 year
Vitamin D serum levels
Time Frame: 1 year
Determine serum levels of vitamin D , basal and after treatment in patients included in this study
1 year
Season levels of vitamin D
Time Frame: 1 year
Compare serum levels of vitamin D in different seasons
1 year
Serum vitamin D levels and clinical control of asthma
Time Frame: 1 year
to determine the correlation between serum levels of vitamin d with clinical asthma control
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emmanuelle Dexeus Gabriel Fernandez, pediatrician, Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HGNAE 05

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