AsthmaPhase 3NCT02571660
Efficacy of Vitamin D on the Clinical Management of Pediatric Patients With Asthma
A Phase 3 study testing GINA treatment fot asthma +vit.D low supplementation dose and GINA treatment fot asthma +vit.D high supplementation dose in people with Asthma, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- GINA treatment fot asthma +vit.D low supplementation dose and GINA treatment fot asthma +vit.D high supplementation dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2015to Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Patients with hypocalcemia or hypercalcemia
- Patients with kidney diseases such as kidney stones, hypercalciuria, renal tubular acidosis
- Patients with moderate to severe malnutrition
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General Naval de Alta Especialidad
Distrito Federal, Mexico City
Emmanuelle Dexeus Gabriel Fernández, Pediatrician, 015548573242, efv_35@hotmail.com
Julissa Ramirez Abarca, Pediatrician, 015545894581, julissa_abarca@hotmail.com
About this study
Official title: 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:
Read more
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.
Read the 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
- Conditions
- Asthma
- Being tested
- GINA treatment fot asthma +vit.D low supplementation dose, GINA treatment fot asthma +vit.D high supplementation dose
- Keywords
- vitamin d levels, exacerbation of asthma, asthma control
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GINA treatment fot asthma +vit.D low supplementation doseDrug
Also called SD group
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 doseDrug
Also called TD group
Dose of 1600 IU of vitamin D3 be allocated each 24 hours for 1 year + standard treatment for asthma
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment | Active comparator | GINA treatment fot asthma +vit.D low supplementation dose Receives: Drug: GINA treatment fot asthma +vit.D low supplementation dose |
| conventional treatment + vitamin D3 | Experimental | GINA treatment fot asthma +vit.D high supplementation dose Receives: Drug: GINA treatment fot asthma +vit.D high supplementation dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (5)
Clinical control of asthma
Compare between the groups the clinical control of asthma with the questionary: asthma control test
Measured: 1 year
Lung function
Compare both groups improved lung function measured by spirometry using as parameter FEV 1
Measured: 1 year
Vitamin D serum levels
Determine serum levels of vitamin D , basal and after treatment in patients included in this study
Measured: 1 year
Season levels of vitamin D
Compare serum levels of vitamin D in different seasons
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico Naval
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Jorge Ivan Valencia Moncada, Hospital General Naval de Alta Especialidad - Escuela Medico Naval
- Investigators
- Emmanuelle Dexeus Gabriel Fernandez, pediatrician, Principal investigator, Hospital General Naval de Alta Especialidad - Escuela Medico Naval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571660
- Sponsor's protocol ID
- HGNAE 05
- Status last verified
- Nov 2015
- First submitted
- 6 Oct 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Papadopoulos NG, Arakawa H, Carlsen KH, Custovic A, Gern J, Lemanske R, Le Souef P, Makela M, Roberts G, Wong G, Zar H, Akdis CA, Bacharier LB, Baraldi E, van Bever HP, de Blic J, Boner A, Burks W, Casale TB, Castro-Rodriguez JA, Chen YZ, El-Gamal YM, Everard ML, Frischer T, Geller M, Gereda J, Goh DY, Guilbert TW, Hedlin G, Heymann PW, Hong SJ, Hossny EM, Huang JL, Jackson DJ, de Jongste JC, Kalayci O, Ait-Khaled N, Kling S, Kuna P, Lau S, Ledford DK, Lee SI, Liu AH, Lockey RF, Lodrup-Carlsen K, Lotvall J, Morikawa A, Nieto A, Paramesh H, Pawankar R, Pohunek P, Pongracic J, Price D, Robertson C, Rosario N, Rossenwasser LJ, Sly PD, Stein R, Stick S, Szefler S, Taussig LM, Valovirta E, Vichyanond P, Wallace D, Weinberg E, Wennergren G, Wildhaber J, Zeiger RS. International consensus on (ICON) pediatric asthma. Allergy. 2012 Aug;67(8):976-97. doi: 10.1111/j.1398-9995.2012.02865.x. Epub 2012 Jun 15.
PubMed 22702533Hill VL, Wood PR. Asthma epidemiology, pathophysiology, and initial evaluation. Pediatr Rev. 2009 Sep;30(9):331-5; quiz 335-6. doi: 10.1542/pir.30-9-331.
PubMed 19726699Wood PR, Hill VL. Practical management of asthma. Pediatr Rev. 2009 Oct;30(10):375-85; quiz 385. doi: 10.1542/pir.30-10-375.
PubMed 19797480Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99. doi: 10.1164/rccm.200801-060ST.
PubMed 19535666Worldwide variations in the prevalence of asthma symptoms: the International Study of Asthma and Allergies in Childhood (ISAAC). Eur Respir J. 1998 Aug;12(2):315-35. doi: 10.1183/09031936.98.12020315.
PubMed 9727780Murphy DM, O'Byrne PM. Recent advances in the pathophysiology of asthma. Chest. 2010 Jun;137(6):1417-26. doi: 10.1378/chest.09-1895.
PubMed 20525652Berry M, Morgan A, Shaw DE, Parker D, Green R, Brightling C, Bradding P, Wardlaw AJ, Pavord ID. Pathological features and inhaled corticosteroid response of eosinophilic and non-eosinophilic asthma. Thorax. 2007 Dec;62(12):1043-9. doi: 10.1136/thx.2006.073429. Epub 2007 Mar 13.
PubMed 17356056Majak P, Olszowiec-Chlebna M, Smejda K, Stelmach I. Vitamin D supplementation in children may prevent asthma exacerbation triggered by acute respiratory infection. J Allergy Clin Immunol. 2011 May;127(5):1294-6. doi: 10.1016/j.jaci.2010.12.016. Epub 2011 Feb 18. No abstract available.
PubMed 21315433Bar Yoseph R, Livnat G, Schnapp Z, Hakim F, Dabbah H, Goldbart A, Bentur L. The effect of vitamin D on airway reactivity and inflammation in asthmatic children: A double-blind placebo-controlled trial. Pediatr Pulmonol. 2015 Aug;50(8):747-53. doi: 10.1002/ppul.23076. Epub 2014 Jul 2.
PubMed 24989842Castro M, King TS, Kunselman SJ, Cabana MD, Denlinger L, Holguin F, Kazani SD, Moore WC, Moy J, Sorkness CA, Avila P, Bacharier LB, Bleecker E, Boushey HA, Chmiel J, Fitzpatrick AM, Gentile D, Hundal M, Israel E, Kraft M, Krishnan JA, LaForce C, Lazarus SC, Lemanske R, Lugogo N, Martin RJ, Mauger DT, Naureckas E, Peters SP, Phipatanakul W, Que LG, Sheshadri A, Smith L, Solway J, Sullivan-Vedder L, Sumino K, Wechsler ME, Wenzel S, White SR, Sutherland ER; National Heart, Lung, and Blood Institute's AsthmaNet. Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. JAMA. 2014 May;311(20):2083-91. doi: 10.1001/jama.2014.5052.
PubMed 24838406Martineau AR, MacLaughlin BD, Hooper RL, Barnes NC, Jolliffe DA, Greiller CL, Kilpin K, McLaughlin D, Fletcher G, Mein CA, Hoti M, Walton R, Grigg J, Timms PM, Rajakulasingam RK, Bhowmik A, Rowe M, Venton TR, Choudhury AB, Simcock DE, Sadique Z, Monteiro WR, Corrigan CJ, Hawrylowicz CM, Griffiths CJ. Double-blind randomised placebo-controlled trial of bolus-dose vitamin D3 supplementation in adults with asthma (ViDiAs). Thorax. 2015 May;70(5):451-7. doi: 10.1136/thoraxjnl-2014-206449. Epub 2015 Feb 27.
PubMed 25724847Unuvar T, Buyukgebiz A. Nutritional rickets and vitamin D deficiency in infants, children and adolescents. Pediatr Endocrinol Rev. 2010 Mar-Apr;7(3):283-91.
PubMed 20526242Brehm JM, Schuemann B, Fuhlbrigge AL, Hollis BW, Strunk RC, Zeiger RS, Weiss ST, Litonjua AA; Childhood Asthma Management Program Research Group. Serum vitamin D levels and severe asthma exacerbations in the Childhood Asthma Management Program study. J Allergy Clin Immunol. 2010 Jul;126(1):52-8.e5. doi: 10.1016/j.jaci.2010.03.043. Epub 2010 Jun 9.
PubMed 20538327Dabbah H, Bar Yoseph R, Livnat G, Hakim F, Bentur L. Bronchial Reactivity, Inflammatory and Allergic Parameters, and Vitamin D Levels in Children With Asthma. Respir Care. 2015 Aug;60(8):1157-63. doi: 10.4187/respcare.03763. Epub 2015 Apr 21.
PubMed 25899478Bener A, Ehlayel MS, Tulic MK, Hamid Q. Vitamin D deficiency as a strong predictor of asthma in children. Int Arch Allergy Immunol. 2012;157(2):168-75. doi: 10.1159/000323941. Epub 2011 Oct 6.
PubMed 21986034
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vitamin D on the Clinical Management of Pediatric Patients With Asthma in the Hospital General Naval de Alta Especialidad
- ClinicalTrials.gov ID
- NCT02571660
- Acronym / sponsor ID
- HGNAE 05
- Conditions
- Asthma
- Keywords
- vitamin d levels, exacerbation of asthma, asthma control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico NavalOther government
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional treatment | Active comparator | Drug: GINA treatment fot asthma +vit.D low supplementation doseGINA treatment fot asthma +vit.D low supplementation dose |
| conventional treatment + vitamin D3 | Experimental | Drug: GINA treatment fot asthma +vit.D high supplementation doseGINA treatment fot asthma +vit.D high supplementation dose |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with hypocalcemia or hypercalcemia
- Patients with kidney diseases such as kidney stones, hypercalciuria, renal tubular acidosis
- Patients with moderate to severe malnutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GINA treatment fot asthma +vit.D low supplementation doseAlso: SD groupDose of 400 IU of vitamin D3 every 24 hours for 1 year + the standard treatment for asthma, | Drug | conventional treatment |
| GINA treatment fot asthma +vit.D high supplementation doseAlso: TD groupDose of 1600 IU of vitamin D3 be allocated each 24 hours for 1 year + standard treatment for asthma | Drug | conventional treatment + vitamin D3 |
Primary outcome
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
5 secondary outcomes
Clinical control of asthma
Time frame: 1 year
Lung function
Time frame: 1 year
Vitamin D serum levels
Time frame: 1 year
Season levels of vitamin D
Time frame: 1 year
Serum vitamin D levels and clinical control of asthma
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- Background: PubMed 22702533Papadopoulos NG, Arakawa H, Carlsen KH, Custovic A, Gern J, Lemanske R, Le Souef P, Makela M, Roberts G, Wong G, Zar H, Akdis CA, Bacharier LB, Baraldi E, van Bever HP, de Blic J, Boner A, Burks W, Casale TB, Castro-Rodriguez JA, Chen YZ, El-Gamal YM, Everard ML, Frischer T, Geller M, Gereda J, Goh DY, Guilbert TW, Hedlin G, Heymann PW, Hong SJ, Hossny EM, Huang JL, Jackson DJ, de Jongste JC, Kalayci O, Ait-Khaled N, Kling S, Kuna P, Lau S, Ledford DK, Lee SI, Liu AH, Lockey RF, Lodrup-Carlsen K, Lotvall J, Morikawa A, Nieto A, Paramesh H, Pawankar R, Pohunek P, Pongracic J, Price D, Robertson C, Rosario N, Rossenwasser LJ, Sly PD, Stein R, Stick S, Szefler S, Taussig LM, Valovirta E, Vichyanond P, Wallace D, Weinberg E, Wennergren G, Wildhaber J, Zeiger RS. International consensus on (ICON) pediatric asthma. Allergy. 2012 Aug;67(8):976-97. doi: 10.1111/j.1398-9995.2012.02865.x. Epub 2012 Jun 15.
- Results publication: PubMed 19726699Hill VL, Wood PR. Asthma epidemiology, pathophysiology, and initial evaluation. Pediatr Rev. 2009 Sep;30(9):331-5; quiz 335-6. doi: 10.1542/pir.30-9-331.
- Results publication: PubMed 19797480Wood PR, Hill VL. Practical management of asthma. Pediatr Rev. 2009 Oct;30(10):375-85; quiz 385. doi: 10.1542/pir.30-10-375.
- Results publication: PubMed 19535666Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99. doi: 10.1164/rccm.200801-060ST.
- Results publication: PubMed 9727780Worldwide variations in the prevalence of asthma symptoms: the International Study of Asthma and Allergies in Childhood (ISAAC). Eur Respir J. 1998 Aug;12(2):315-35. doi: 10.1183/09031936.98.12020315.
- Results publication: PubMed 20525652Murphy DM, O'Byrne PM. Recent advances in the pathophysiology of asthma. Chest. 2010 Jun;137(6):1417-26. doi: 10.1378/chest.09-1895.
- Results publication: PubMed 17356056Berry M, Morgan A, Shaw DE, Parker D, Green R, Brightling C, Bradding P, Wardlaw AJ, Pavord ID. Pathological features and inhaled corticosteroid response of eosinophilic and non-eosinophilic asthma. Thorax. 2007 Dec;62(12):1043-9. doi: 10.1136/thx.2006.073429. Epub 2007 Mar 13.
- Results publication: PubMed 21315433Majak P, Olszowiec-Chlebna M, Smejda K, Stelmach I. Vitamin D supplementation in children may prevent asthma exacerbation triggered by acute respiratory infection. J Allergy Clin Immunol. 2011 May;127(5):1294-6. doi: 10.1016/j.jaci.2010.12.016. Epub 2011 Feb 18. No abstract available.
- Results publication: PubMed 24989842Bar Yoseph R, Livnat G, Schnapp Z, Hakim F, Dabbah H, Goldbart A, Bentur L. The effect of vitamin D on airway reactivity and inflammation in asthmatic children: A double-blind placebo-controlled trial. Pediatr Pulmonol. 2015 Aug;50(8):747-53. doi: 10.1002/ppul.23076. Epub 2014 Jul 2.
- Results publication: PubMed 24838406Castro M, King TS, Kunselman SJ, Cabana MD, Denlinger L, Holguin F, Kazani SD, Moore WC, Moy J, Sorkness CA, Avila P, Bacharier LB, Bleecker E, Boushey HA, Chmiel J, Fitzpatrick AM, Gentile D, Hundal M, Israel E, Kraft M, Krishnan JA, LaForce C, Lazarus SC, Lemanske R, Lugogo N, Martin RJ, Mauger DT, Naureckas E, Peters SP, Phipatanakul W, Que LG, Sheshadri A, Smith L, Solway J, Sullivan-Vedder L, Sumino K, Wechsler ME, Wenzel S, White SR, Sutherland ER; National Heart, Lung, and Blood Institute's AsthmaNet. Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial. JAMA. 2014 May;311(20):2083-91. doi: 10.1001/jama.2014.5052.
- Results publication: PubMed 25724847Martineau AR, MacLaughlin BD, Hooper RL, Barnes NC, Jolliffe DA, Greiller CL, Kilpin K, McLaughlin D, Fletcher G, Mein CA, Hoti M, Walton R, Grigg J, Timms PM, Rajakulasingam RK, Bhowmik A, Rowe M, Venton TR, Choudhury AB, Simcock DE, Sadique Z, Monteiro WR, Corrigan CJ, Hawrylowicz CM, Griffiths CJ. Double-blind randomised placebo-controlled trial of bolus-dose vitamin D3 supplementation in adults with asthma (ViDiAs). Thorax. 2015 May;70(5):451-7. doi: 10.1136/thoraxjnl-2014-206449. Epub 2015 Feb 27.
- Results publication: PubMed 20526242Unuvar T, Buyukgebiz A. Nutritional rickets and vitamin D deficiency in infants, children and adolescents. Pediatr Endocrinol Rev. 2010 Mar-Apr;7(3):283-91.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle Dexeus Gabriel Fernandez, pediatrician principal investigator
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GINA treatment fot asthma +vit.D low supplementation dose and GINA treatment fot asthma +vit.D high supplementation dose in people with Asthma, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuelle Dexeus Gabriel Fernandez, pediatrician (015548573242, efv_35@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free lapse of asthma exacerbation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02571660, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.