Vitamin D Oral Replacement in Asthma | Clinical Trial

Key information

Conditions

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

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Hospital, Little Rock, Arkansas, United States

About this study

This study has two parts. In part 1, study participants will be randomized to receive one of four doses of vitamin D supplementation in international units (IU) over at 16-week period: 1) Single 50,000 IU loading dose + 6000 IU daily dose; 2) Single 50,000 IU loading dose + 10,000 IU daily dose: 3) 6000 IU daily dose; or 4) 600 IU daily dose. Based on pharmacokinetic analysis, one of the doses (1-3) will be selected to use in part 2.

In part 2, study participants will be randomized to the dose selected in part 1 or the 600 IU daily dose of vitamin D supplementation to be administered over a 16-week dosing period.

Across both parts, safety of each dose regimen of vitamin D supplementation will be evaluated, and the effectiveness of each dose to achieve a serum level of 25(OH)D greater than or equal to 40 ng/ml will be assessed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Body mass index greater than or equal to 85% for age and sex
Physician-diagnosed asthma
Ongoing relationship with asthma provider responsible for asthma care
Serum 25(OH) D level 10 ng/ml to less than 30 ng/ml at screening visit based on local laboratory test
Ability to swallow pills similar in size to the vitamin D preparation to be used
Signed consent form from parent, legal guardian or caregiver and signed assent from participant (as appropriate)
Females of childbearing years must not be pregnant, must not be lactating and must agree to practice adequate birth control method
Child and parent, legal guardian, or caregiver must speak English or Spanish

Exclusion criteria

Known diseases of calcium metabolism or the parathyroid
History of renal insufficiency or kidney stones
Known liver failure or history of abnormal liver function tests
History of Williams syndrome, sarcoidosis, or granulomatous disease
Active tuberculosis
Spot urine calcium/creatinine ration greater than 0.37 (calcium and creatinine measured in mg/ml). This can be repeated following adequate hydration
Clinical evidence of rickets
Taking supplemental vitamin D greater than equal to 1000 IU per day

Treatment and study plan

Vitamin D3 oral regimen

Dietary Supplement

Vitamin D3 oral regimens supplementation

Primary outcomes

Part 1: Optimal Dosing Level to Use in Part 2

Time frame: 20 weeks

Determine the best vitamin D supplementation level based on PK analysis of participants enrolled in Part 1. The PK of 25(OH)D after vitamin D supplementation in children will be characterized using a 2-compartment population PK model (popPK) with linear absorption and elimination kinetics.
Part 2: Proportion of Participants With Vitamin D Levels >= 40 ng/ml

Time frame: 16 weeks

Proportion of participants in part 2 who achieve vitamin levels >= 40 ng/ml

Sponsors and collaborators

Lead sponsor

IDeA States Pediatric Clinical Trials Network

Network

Collaborators

National Institutes of Health (NIH)

Registry information

Acronym: VDORA1

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Sep 26, 2018
Registry last updated: Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed