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

NCT05431920 | Active Not Recruiting DMC

• 1 other identifier: HIM/2021/023
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-allergic Asthma; Obesity; Vitamin D Deficiency

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Other Outcomes (2)

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

  12 weeks

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

  12 weeks

Study Arms (2)

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)

Active control

ACTIVE COMPARATOR

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

Dietary Supplement: Vitamin D₃ (25-hydroxy vitamin D)

Interventions

Vitamin D₃ (25-hydroxy vitamin D) DIETARY_SUPPLEMENT

Vitamin D3 oral supplementation

Experimental

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

Study Sites (1)

Hospital Infantil de México Federico Gómez

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Obesity; Vitamin D Deficiency; Asthma

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Avitaminosis; Deficiency Diseases; Malnutrition; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alternate investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 24, 2022
• Study Start: October 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)