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

Phase 3

• Conditions: Asthma
• Interventions: Drug: GINA treatment fot asthma +vit.D low supplementation dose; Drug: GINA treatment fot asthma +vit.D high supplementation dose

• Registration Number: NCT02571660
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-08
• Status Verified: 2015-11
• Study Start: 2015-11
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-11-25
• Primary Completion: 2016-11
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional treatment	GINA treatment fot asthma +vit.D low supplementation dose	GINA treatment fot asthma +vit.D low supplementation dose
conventional treatment + vitamin D3	GINA treatment fot asthma +vit.D high supplementation dose	GINA treatment fot asthma +vit.D high supplementation dose

Primary Outcome Measures

Name	Time	Method
Free lapse of asthma exacerbation	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

Name	Time	Method
Lung function	1 year	Compare both groups improved lung function measured by spirometry using as parameter FEV 1
Vitamin D serum levels	1 year	Determine serum levels of vitamin D , basal and after treatment in patients included in this study
Clinical control of asthma	1 year	Compare between the groups the clinical control of asthma with the questionary: asthma control test
Season levels of vitamin D	1 year	Compare serum levels of vitamin D in different seasons
Serum vitamin D levels and clinical control of asthma	1 year	to determine the correlation between serum levels of vitamin d with clinical asthma control

Trial Locations

Locations (1)

Hospital General Naval de Alta Especialidad; 🇲🇽 Distrito Federal, Mexico