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

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ClinicalTrials.gov Identifier: NCT05431920
Recruitment Status : Recruiting
First Posted : June 24, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Blanca Estela Del Rio Navarro, Hospital Infantil de Mexico Federico Gomez

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.


Condition or disease Intervention/treatment Phase
Non-allergic Asthma Obesity Vitamin D Deficiency Dietary Supplement: Vitamin D₃ (25-hydroxy vitamin D) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.
Primary Purpose: Treatment
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
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Vitamin D3: single 50,000 IU loading dose + 4,000 IU daily dose for three months
Dietary Supplement: Vitamin D₃ (25-hydroxy vitamin D)
Vitamin D3 oral supplementation

Active Comparator: Active control
Vitamin D3: 2,000 IU daily dose for three months
Dietary Supplement: Vitamin D₃ (25-hydroxy vitamin D)
Vitamin D3 oral supplementation




Primary Outcome Measures :
  1. Evaluate the effects of vitamin D supplementation daily for three months on asthma symptoms. [ Time Frame: 12 weeks ]
    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 :
  1. Evaluate the effects of vitamin D supplementation daily for three months on the incidence of asthmatic crisis. [ Time Frame: 12 weeks ]
    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.


Other Outcome Measures:
  1. Evaluate the effects of vitamin D supplementation daily for three months on lung function. [ Time Frame: 12 weeks ]
    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.

  2. Evaluate the effects of vitamin D supplementation for three months on IL-17A inflammatory biomarker. [ Time Frame: 12 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05431920


Contacts
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Contact: Blanca Estela Del Río Navarro, MD 5552289917 ext 2150 blancadelrionavarro@gmail.com
Contact: Nayely Reyes Noriega, MD, PhD 5552289917 ext 2150 naye.rey.nor@gmail.com

Locations
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Mexico
Hospital Infantil de México Federico Gómez Recruiting
Mexico City, Mexico, 06720
Contact: Fengyang Huang, MD, PhD    5552289917 ext 3308    huangfengyang@gmail.com   
Contact: Nayely Reyes Noriega, MD, PhD    5552289917 ext 2150    naye.rey.nor@gmail.com   
Sponsors and Collaborators
Hospital Infantil de Mexico Federico Gomez
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Responsible Party: Blanca Estela Del Rio Navarro, Alternate investigator, Hospital Infantil de Mexico Federico Gomez
ClinicalTrials.gov Identifier: NCT05431920    
Other Study ID Numbers: HIM/2021/023
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Blanca Estela Del Rio Navarro, Hospital Infantil de Mexico Federico Gomez:
asthma
obesity
non allergic asthma
adolescents
vitamin D
25-hydroxyvitamin D
Additional relevant MeSH terms:
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Asthma
Obesity
Vitamin D Deficiency
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Vitamin D
Ergocalciferols
Cholecalciferol
Hydroxycholecalciferols
Calcifediol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents