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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02571660
• Other study ID #: HGNAE 05
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 6, 2015
• Last updated: November 24, 2015
• Start date: November 2015
• Est. completion date: July 2017

Study information

• Verified date: November 2015
• Source: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
• Contact: Emmanuelle Dexeus Gabriel Fernandez, pediatrician
• Phone: 015548573242
• Email: efv_35[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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,
• 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

Locations

Country	Name	City	State
Mexico	Hospital General Naval de Alta Especialidad	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

Country where clinical trial is conducted

Mexico, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

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