Effects of Vitamin D Supplementation in Adolescents With Asthma, Obesity and Vitamin D Deficiency.

  • STATUS
    Recruiting
  • End date
    Aug 1, 2024
  • participants needed
    264
  • sponsor
    Hospital Infantil de Mexico Federico Gomez
Updated on 12 July 2022
body mass index

Summary

Obesity has been associated with a specific non-allergic asthma phenotype and to a deficiency of vitamin D in at least 90% of the pediatric population. Adolescents with non-allergic asthma and vitamin D deficiency have up to six times the risk [OR: 6.2 (IC95% 2.0-21.6), p=0.002] of having a severe asthmatic crisis and do not respond adequately to inhaled steroid treatment.

To evaluate the effect of oral vitamin D3 supplementation with 50,000 IU single dose and 4,000 IU daily vs 2,000 IU daily on the Asthma Control Questionnaire score, number and incidence of asthmatic crisis, lung function, and Th17 inflammatory biomarkers in adolescents with asthma associated to obesity and vitamin D insufficiency/deficiency for three months.

Description

Randomized controlled, double-blind, parallel (2 arms), clinical trial. Eligibility criteria: adolescents (12-17 years old), with obesity, vitamin D deficiency (<30 ng/dl), controlled or partially controlled or uncontrolled asthma according to GINA 2020 criteria and confirmed with a spirometry, with negative allergy skin test.

To each patient it will be performed a medical history, physical examination, asthma control questionnaire, a spirometry (with bronchodilator), as well as a peripheral blood sample collection of 10 ml to measure Th17 inflammatory biomarkers by chemiluminescence immunoassay and quantitative polymerase chain reaction (genetic expression of 18 cytokines) and 25-hydroxyvitamin D plasmatic concentration with electrochemiluminescence.

Patients will be randomized by block and assigned to one of two intervention arms. Each intervention arm will have a total sample of 132 patients. Experimental group will receive a single dose of 50,000 IU and 4,000 IU of vitamin D daily for 3 months. On the other hand, the active control group will receive 2,000 IU daily for 3 months. Patients will be followed up and cited every month for clinical assessment, asthma control (ACQ) questionnaire application, spirometry (with bronchodilator) and peripheral blood sample collection to determine the plasma concentration of 25-hydroxyvitamin D and Th17 inflammatory biomarkers.

Details
Condition Non-allergic Asthma, Obesity, Vitamin D Deficiency
Treatment Vitamin D₃ (25-hydroxy vitamin D)
Clinical Study IdentifierNCT05431920
SponsorHospital Infantil de Mexico Federico Gomez
Last Modified on12 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adolescents of 12 to 17 years old
Diagnosis of exogen obesity with a body mass index (BMI) greater than percentile 95 for age and sex, according to the Center for Disease Control and Prevention (CDC) graphics, that precedes the diagnosis of asthma
Plasmatic concentration of 25-hydroxyvitamin D less than 30 ng/ml at screening visit based on local laboratory test
Physician-diagnosed asthma, with more than 6 months of evolution, based on medical history, physical examination, clinical criteria according to the Global Initiative For Asthma 2020 (GINA) and confirmed with a spirometry with reversibility after the administration of a bronchodilator
Asthma severity (intermittent or mild persistent or moderate persistent) according to the National Asthma Education and Prevention Program (NAEPP) and classified as controlled, partly controlled or uncontrolled according to GINA 2020
Negative allergic skin tests

Exclusion Criteria

History of systemic or chronic degenerative disease (renal, pulmonar, cardiovascular, infectious, muscular, immunological, hypertension, diabetes mellitus, cancer, nonalcoholic fatty liver disease)
Current treatment with immunomodulators or immunostimulants, up to 6 months before the intervention
History of adverse effects to vitamin D
Treatment with oral steroids 3 months previous to the enrollment
Active smoking
Elimination criteria
Parents, tutors, legal guardians or participants that decide to withdraw from the study any time
Pregnancy during study
Severe adverse effects to vitamin D
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note