A Phase 3 interventional study of GINA treatment fot asthma +vit.D low supplementation dose and GINA treatment fot asthma +vit.D high supplementation dose in Asthma, sponsored by Hospital General Naval de Alta Especialidad - Escuela Medico Naval. Status unknown at 1 site in Mexico. Open to participants aged 7 Years to 15 Years. Per ClinicalTrials.gov, last updated 2015-11-25.
Sponsored by Hospital General Naval de Alta Especialidad - Escuela Medico Naval · Phase 3, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 100 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Hospital General Naval de Alta Especialidad - Escuela Medico Naval is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
GINA treatment fot asthma +vit.D low supplementation dose
Drug: GINA treatment fot asthma +vit.D low supplementation dose
GINA treatment fot asthma +vit.D high supplementation dose
Drug: GINA treatment fot asthma +vit.D high supplementation dose
Dose of 400 IU of vitamin D3 every 24 hours for 1 year + the standard treatment for asthma,
Also known as: SD group
Dose of 1600 IU of vitamin D3 be allocated each 24 hours for 1 year + standard treatment for asthma
Also known as: TD group
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
Time frame: 1 year
Clinical control of asthma
Compare between the groups the clinical control of asthma with the questionary: asthma control test
Time frame: 1 year
Lung function
Compare both groups improved lung function measured by spirometry using as parameter FEV 1
Time frame: 1 year
Vitamin D serum levels
Determine serum levels of vitamin D , basal and after treatment in patients included in this study
Time frame: 1 year
Season levels of vitamin D
Compare serum levels of vitamin D in different seasons
Time frame: 1 year
Serum vitamin D levels and clinical control of asthma
to determine the correlation between serum levels of vitamin d with clinical asthma control
Time frame: 1 year
This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Hospital General Naval de Alta Especialidad - Escuela Medico Naval