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

Primary Purpose

Non-allergic Asthma, Obesity, Vitamin D Deficiency

Status

Recruiting

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Vitamin D₃ (25-hydroxy vitamin D)

About this trial

This is an interventional treatment trial for Non-allergic Asthma focused on measuring asthma, obesity, non allergic asthma, adolescents, vitamin D, 25-hydroxyvitamin D

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Infantil de México Federico GómezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Active control

Arm Description

Vitamin D3: single 50,000 IU loading dose + 4,000 IU daily dose for three months

Vitamin D3: 2,000 IU daily dose for three months

Outcomes

Primary Outcome Measures

Evaluate the effects of vitamin D supplementation daily for three months on asthma symptoms.

Evaluate the effects of vitamin D supplementation, with a single dose of 50,000 IU and 4,000 IU daily for three months, on asthma symptoms improvement (reduction of 0.5 in score compared to baseline), assessed by an asthma control questionnaire [score range from 0 (fully controlled) to 6 (severely uncontrolled)], compared to a dose of 2,000 IU daily.

Secondary Outcome Measures

Evaluate the effects of vitamin D supplementation daily for three months on the incidence of asthmatic crisis.

Evaluate the effects of vitamin D supplementation, with a single dose 50,000 IU and 4,000 IU daily for three months, on asthma symptoms evaluated the incidence of asthmatic crisis compared to a dose of 2,000 IU daily.

Full Information

NCT ID

NCT05431920

First Posted

June 8, 2022

Last Updated

September 20, 2023

Sponsor

Hospital Infantil de Mexico Federico Gomez

1. Study Identification

Unique Protocol Identification Number

NCT05431920

Brief Title

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

Official Title

Effects of Vitamin D3 Supplementation in Asthma Control, Pulmonary Function and Th17 Inflammatory Biomarkers in Adolescents With Asthma, Obesity and Vitamin D Deficiency: a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Infantil de Mexico Federico Gomez

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-allergic Asthma, Obesity, Vitamin D Deficiency

Keywords

asthma, obesity, non allergic asthma, adolescents, vitamin D, 25-hydroxyvitamin D

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Adolescents with non-allergic asthma, obesity and insufficiency/deficiency of vitamin D will be randomized in block (33 groups with 8 patients), 2 arms of 132 patients each: the experimental group will receive a single dose of 50,000 IU followed by 4,000 IU daily of vitamin D for three months, and the control group will receive 2,000 IU daily of vitamin D for three months. Each patient will have a monthly follow up (weeks 4, 8 and 12 after the beginning of the intervention) with physical examination, questionnaire to evaluate asthma control, asthma control test and pediatric asthma quality of life questionnaire (PAQLQ), a spirometry with bronchodilator, 10 ml of peripheral blood to measure plasmatic concentration of 25-hydroxyvitamin D with electrochemiluminescence, Th17 inflammatory biomarkers and allergy skin tests (at the beginning and end of the intervention) and each visit will be a capsule count and a registration of adverse effects.

Masking

Care Provider

Masking Description

The masking will be done by a care provider. Each patient will have a randomly assigned envelope with the corresponding vitamin D dose, defining the allocated arm.

Allocation

Randomized

Enrollment

264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Vitamin D3: single 50,000 IU loading dose + 4,000 IU daily dose for three months

Arm Title

Active control

Arm Type

Active Comparator

Arm Description

Vitamin D3: 2,000 IU daily dose for three months

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D₃ (25-hydroxy vitamin D)

Intervention Description

Vitamin D3 oral supplementation

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D₃ (25-hydroxy vitamin D)

Intervention Description

Vitamin D3 oral supplementation

Primary Outcome Measure Information:

Title

Evaluate the effects of vitamin D supplementation daily for three months on asthma symptoms.

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Evaluate the effects of vitamin D supplementation daily for three months on the incidence of asthmatic crisis.

Description

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Evaluate the effects of vitamin D supplementation daily for three months on lung function.

Description

Evaluate the effects of vitamin D supplementation, with a single dose 50,000 IU and 4,000 IU daily for three months, on lung function (Forced expiratory volume in the first second, 5% volume increase compared to baseline) compared to a dose of 2,000 IU daily.

Time Frame

12 weeks

Title

Evaluate the effects of vitamin D supplementation for three months on IL-17A inflammatory biomarker.

Description

Evaluate the effects of vitamin D supplementation, with a single dose of 50,000 IU and 4,000 IU daily for three months, on IL-17A (decrease of 5 pg/ml) compared to a dose of 2,000 IU daily.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Blanca Estela Del Río Navarro, MD

Phone

5552289917

Ext

2150

blancadelrionavarro@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Nayely Reyes Noriega, MD, PhD

Phone

5552289917

Ext

2150

naye.rey.nor@gmail.com

Facility Information:

Facility Name

Hospital Infantil de México Federico Gómez

City

Mexico City

ZIP/Postal Code

06720

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fengyang Huang, MD, PhD

Phone

5552289917

Ext

3308

huangfengyang@gmail.com

First Name & Middle Initial & Last Name & Degree

Nayely Reyes Noriega, MD, PhD

Phone

5552289917

Ext

2150

naye.rey.nor@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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