Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02571660
Recruitment Status : Unknown
Verified November 2015 by Dr. Jorge Ivan Valencia Moncada, Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
Recruitment status was:  Not yet recruiting
First Posted : October 8, 2015
Last Update Posted : November 25, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Jorge Ivan Valencia Moncada, Hospital General Naval de Alta Especialidad - Escuela Medico Naval

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.


Condition or disease Intervention/treatment Phase
Asthma Drug: GINA treatment fot asthma +vit.D low supplementation dose Drug: GINA treatment fot asthma +vit.D high supplementation dose Phase 3

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Vitamin D on the Clinical Management of Pediatric Patients With Asthma in the Hospital General Naval de Alta Especialidad
Study Start Date : November 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
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 Name: 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 Name: TD group




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Clinical control of asthma [ Time Frame: 1 year ]
    Compare between the groups the clinical control of asthma with the questionary: asthma control test

  2. Lung function [ Time Frame: 1 year ]
    Compare both groups improved lung function measured by spirometry using as parameter FEV 1

  3. Vitamin D serum levels [ Time Frame: 1 year ]
    Determine serum levels of vitamin D , basal and after treatment in patients included in this study

  4. Season levels of vitamin D [ Time Frame: 1 year ]
    Compare serum levels of vitamin D in different seasons

  5. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571660


Contacts
Layout table for location contacts
Contact: Emmanuelle Dexeus Gabriel Fernandez, pediatrician 015548573242 efv_35@hotmail.com
Contact: Julissa Ramirez, pediatrician 015545894581 julissa_abarca@hotmail.co

Locations
Layout table for location information
Mexico
Hospital General Naval de Alta Especialidad Not yet recruiting
Distrito Federal, Mexico
Contact: Emmanuelle Dexeus Gabriel Fernández, Pediatrician    015548573242    efv_35@hotmail.com   
Contact: Julissa Ramirez Abarca, Pediatrician    015545894581    julissa_abarca@hotmail.com   
Sponsors and Collaborators
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Investigators
Layout table for investigator information
Principal Investigator: Emmanuelle Dexeus Gabriel Fernandez, pediatrician Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Publications of Results:

Other Publications:
Layout table for additonal information
Responsible Party: Dr. Jorge Ivan Valencia Moncada, Dr. Emmanuelle Dexeus Gabriel Fernandez Vera, Hospital General Naval de Alta Especialidad - Escuela Medico Naval
ClinicalTrials.gov Identifier: NCT02571660     History of Changes
Other Study ID Numbers: HGNAE 05
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015

Keywords provided by Dr. Jorge Ivan Valencia Moncada, Hospital General Naval de Alta Especialidad - Escuela Medico Naval:
vitamin d levels
exacerbation of asthma
asthma control

Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents